clinical research organisations australia

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List of Contract Research Organizations in Australia

Featured cros.

iNGENū is the FDA-centric Australian CRO championing disruptive, innovative biotech firms globally. Our core mission is to create access to high quality clinical research globally, for early to mid-stage biotechs by removing financial and other unnec...

IMS Health and Quintiles are now IQVIA, a world leader in using data, technology, advanced analytics and expertise to help customers drive healthcare - and human health - forward. Together with the companies we serve, we are enabling a more modern, m...

Local, small- and mid-size Contract Research Organizations in Australia

We assist biotechnology, medical device and pharmaceutical start-ups and SMSEs to refine and fast-track their research goals through efficient study design, SAPs and protocol development and adaption, and careful statistical analysis of study endpoin... View full profile

• United Kingdom

At Australian Healthcare Solutions, we believe in medical technology that changes lives for the better.  Australian Healthcare Solutions was founded from the desire to assist companies achieve their vision of delivering credible, safe and cost-effect... View full profile

With our team of experienced personnel and state-of-the-art technology, we are the premier CRO of choice in Australia offering a full suite of services in-house. Avance Clinical's clinical and data capabilities cover all phases and therapeutic areas... View full profile

At Clinexa, we are in a constant pursuit to identify the best ways to pass value to our clients. We challenge ourselves and our stakeholders to create new and innovative models that take into consideration the needs of today’s clinical development ne... View full profile

Clinical Research Australia is a contract research organisation located in Perth, Western Australia. We specialise in conducting clinical trials on natural treatments to enhance mental and physical well-being. Our Mission Statement: “To provide an ef... View full profile

CMAX is one of Australia’s largest and most experienced Phase I-II clinical trial units. Centrally positioned in Adelaide, South Australia, CMAX is located opposite the Royal Adelaide Hospital and adjacent to the innovative BioMed City precinct. Ope... View full profile

Complete Phase CRO is a full-service Contract Research Organization (CRO) offering clinical trial solutions in Australia and New Zealand. View full profile

CROW Clinical is a full-service Clinical Research Organization (CRO) servicing Australia and New Zealand. We are the only CRO that offers a dedicated team of Field Clinical Engineers (FCEs) or MedTech Engineers. Our specialty is supporting high-tech... View full profile

GenesisCare Clinical CRO is an independent company founded by GenesisCare, with people skilled across the full spectrum of traditional CRO service offerings yet connected through GenesisCare to additional research services and investigator sites. Why... View full profile

• United States

InClin is a full service Contract Research Organization with offices in the San Francisco Bay Area and Sydney, Australia. We are a single source provider of an integrated full suite of clinical development services from Phase 1 through Phase 4, inclu... View full profile

Nucleus Network is Australia’s largest Phase 1 clinical research organization and the only Phase 1 specialist globally with facilities in the USA and Australia. Since our establishment in 2004, Nucleus Network has conducted well over 1000 Phase 1 cli... View full profile

Pacific Clinical Research GroupTM (PCRG) has 18 years of consistent success, with 94% of our clients achieving their primary objective – whether it be clinical, regulatory or strategic/financial. The PCRG Chairman works full-time for the Company, and... View full profile

Collaborating on all therapeutic modalities, Resolian fuses expertise from Alliance Pharma and Drug Development Solutions to provide world-class scientific solutions. View full profile

Southern Star Research is a leading Australian, privately owned, full-service Contract Research Organisation, specialising in providing clinical research services for pharmaceutical, medical device and biotechnology clinical trials. With a head offic... View full profile

Global Contract Research Organizations in Australia

ACROSS Global is a unique, full-service, comprehensive alliance of qualified CROs and Specialist Service Providers dedicated to providing a professional, cost-effective, focused, and seamless service to the pharmaceutical, biopharma and medical devic... View full profile

• Bosnia & Herzegovina
• Congo, DR of
• Philippines
• Saudi Arabia
• South Africa
• South Korea
• Switzerland
• United Arab Emirates

A global, full-service contract research organization. We take your trials personally. dMed Global, a full-service Clinical Contract Research Organization (CRO) based in Shanghai, China and Clinipace Incorporated, a full-service Clinical CRO with hea... View full profile

• Czech Republic

At Charles River, we are passionate about our role in improving the quality of people’s lives. Our mission, our excellent science and our strong sense of purpose guides us in all that we do, and we approach each day with the knowledge that our work h... View full profile

• Netherlands

ClinActis Pte. Ltd., is a leading full-service contract research organisation (CRO) in Asia Pacific. We provide clinical trial services to the pharmaceutical, medical device, medical nutrition and biotech companies in Asia Pacific. Headquartered in... View full profile

As a provider of comprehensive Phase I through IV clinical trial management, clinical pharmacology, patient access solutions and other enabling services, Fortrea partners with emerging and large biopharma and medical device and diagnostic companies t... View full profile

• New Zealand

GreenLight Clinical is internationally recognised by sponsors and investigators as a Physician-led CRO of choice in Ophthalmic & Early-Phase Research. As a full-service CRO, we help customers bring innovative treatments and medical devices to mar... View full profile

Since our foundation in Dublin, Ireland in 1990, our mission has been to help our clients to accelerate the development of drugs and devices that save lives and improve quality of life. We are a global provider of consulting, and outsourced developme... View full profile

iNGENū is the FDA-centric Australian CRO championing disruptive, innovative biotech firms globally. Our core mission is to create access to high quality clinical research globally, for early to mid-stage biotechs by removing financial and other unnec... View full profile

IMS Health and Quintiles are now IQVIA, a world leader in using data, technology, advanced analytics and expertise to help customers drive healthcare - and human health - forward. Together with the companies we serve, we are enabling a more modern, m... View full profile

Medidee’s CRO (Clinical Research Organisation) services are backed up by decades of experience in the fields of medical device engineering, quality and regulatory affairs. This unique combination of all relevant competences supports all aspects of yo... View full profile

Our unique global partnering philosophy emphasizes an uncompromising commitment to clinical research and to the highest level of ethical standards and performance in our jobs. We are selective about the projects we engage in because we are devoted to... View full profile

Headquartered in Australia and focused exclusively on the Asia Pacific, Novotech is internationally recognized as a leading regional full-service CRO. With the increasing pace of globalization in drug development, Novotech’s expertise in the vibrant... View full profile

For over 35 years, PAREXEL has proven to be a trusted partner for the complex development journey required of biopharmaceutical and medical device companies. We’re also an astute guide, able to simplify that journey for our clients, so safe new produ... View full profile

PPD is a leading global contract research organization providing comprehensive, integrated drug development, laboratory and lifecycle management services. Our clients and partners include pharmaceutical, biotechnology, medical device, academic and go... View full profile

ProPharma Group partners with life science companies to solve their complex challenges. As an extension of your team, we care about not only the progression of your products through the development lifecycle, but also the safety of your products and... View full profile

Our mission is to be the best CRO in the world as measured by our employees, clients, investigators, and vendors. Our teams work tirelessly to ensure that we deliver on time and on budget. You will always know what's going on with your study when you... View full profile

Life sciences services from SGS – optimize your development timelines to get medicines and medical devices to market quickly and safely. There is no other area of business that is more heavily regulated than the development, testing and distribution... View full profile

• Burkina Faso
• Cote d'Ivoire
• Dominican Republic
• El Salvador
• Equatorial Guinea
• Papua New Guinea
• Saint Lucia
• Trinidad & Tobago
• Turkmenistan

Syneos Health (Nasdaq:SYNH) is the only fully integrated biopharmaceutical solutions organization purpose-built to accelerate customer success. We lead with a product development mindset, strategically blending clinical development, medical affairs a... View full profile

List of CROs by location

The Global CRO for Biotechs

The full-service Contract Research Organization (CRO) with operations in Australia , New Zealand, Asia , North America , and Europe.

We specialize in delivering world-class operations, providing biotechs with strategic guidance from their early pre-clinical development with our experienced ClinicReady team through to late-phase studies, supported by our proven GlobalReady team. Our focus is on fast, agile, and adaptive operations that are solution-oriented, innovative, and cost-effective, ensuring rapid results and robust data.

With a proven track record and experience spanning across more than 120+ indications, Avance Clinical consistently delivers high-quality data that is accepted by global regulators, including but not limited to the TGA, FDA, MHRA, EMA, MFDS, PDMA.

Avance Clinical distinguishes itself by its commitment to personalized service rather than a one-size-fits-all approach.

FROST & SULLIVAN BEST PRACTICES AWARD

Early phase success.

From comprehensive pre-clinical consultancy services through to phase one trials, we offer fast, agile and adaptive clinical research solutions for biotechs in the early phases of their drug development.

The ClinicReady team, our inhouse scientific and regulatory affairs experts, lay the vital clinical foundations that ensure seamless and successful transition into phase one and beyond.

Late Phase success

Our late phase operations deliver multi-regional clinical excellence across key therapeutic areas including oncology, CNS, rare diseases and infectious diseases. Our global teams apply decades of drug development experience, and leverage the latest technology, including AI and gold standard systems and processes, across all functional areas to deliver an exceptional CRO experience for biotechs.

BIO Taiwan 2024 Meet Avance in Taiwan

26 – 28 July 2024

This year's convention features diverse programs, including Business Partnering, Exhibitions, and Conferences, offering insights on the latest bio-health trends and technologies and exploring global expansion opportunities.

PSYCHEDELICS WEBINAR

Join us for an informative webinar as we delve into the world of psychedelic trials and the evolving regulatory landscape surrounding these transformative therapies.

Oragenics Partners with Avance Clinical for Phase II Concussion Trial in Australia

Oragenics, Inc. (NYSE American: OGEN), a pioneer in developing innovative intranasal pharmaceuticals for neurological disorders, today announced a partnership with Avance Clinical, a leading Contract Research Organization (CRO), to conduct a Phase II clinical trial in Australia

Bringing more than three decades of clinical operations experience.

Preclinical / ClinicReady

Foundations for success across all phases

Early Phase

The most important stage for future success.

Multi-regional expansion with Avance Clinical team

• GlobalReady

Your global roadmap for drug development

Foundations for success across all phases.

ClinicReady is the inhouse scientific and regulatory affairs expert team, your surrogate drug development team. The ClinicReady process supports demonstration of safety and preliminary clinical Proof of Concept and lays the vital clinical foundations that ensures seamless transition into phase one and beyond.

Scientific & Regulatory Affairs

The most experienced global team

Surrogate Drug Development Team

Your outsourced roadmap experts

Proof of Concept

Starting with the right data

Global Expertise 

Across the latest regulatory update

From comprehensive pre-clinical services through to phase one trials, we offer fast, agile and adaptive clinical research solutions for biotechs in the early phases of their drug development.

Pre-clinical Expertise

Three decades of experience informs every step

Adaptive Approach

Responsive and innovative culture

Rapid and Agile

Time and funds are key priorities

43.5% Rebate Potential Across all Phases

Specialist partners for strong financial results

multi-regional expansion with Avance Clinical team

Our late phase operations deliver multi-regional clinical excellence across key therapeutic areas including oncology CNS, rare diseases and infectious diseases. Our experienced global teams leverage the latest technology, AI, RWD and RWE, and gold standard systems and processes across all functional areas.

Multi-regional

Expand globally with the same team

Oncology CNS, Rare Diseases, Infectious Diseases and more

Expertise in key therapeutic areas

Gold Standard Systems and Processes

The latest AI tools plus industry standard systems

One CRO across all Phases

Built for success across all phases

The proprietary GlobalReady process encapsulates the entire drug development journey from robust early phase clinical foundations to seamless multi-regional late phase expansions. All the while retaining the same high quality CRO which reduces time and cost and delivers the highest quality data for regulatory approvals.

Robust Foundations

Early planning with a view to later phase roll-out

Seamless journey

Saving time and funds with a seamless Avance Clinical team

Quality Data 

Track-record of success with main regulatory authorities such as FDA and EMA

Cost & Time Saving

Benefits of the one global team

WHY BIOTECHS CHOOSE AVANCE CLINICAL

Globally accepted data.

Avance Clinical ’s global team s have a world-class reputation for delivering quality data that is accepted by all the international regulatory authorities including FDA and EMA .

LATEST TECHNOLOGY

The Avance Clinical Technology & Innovation unit invests heavily in industry-leading as well as emerging technology platforms that elevate quality, speed, and cost metrics for our biotech clients. As part of this technology focus, Avance Clinical also has certified in-house platform specialists including Medidata trained experts.

IN-HOUSE GLOBAL REGULATORY AFFAIRS

Avance Clinical is one of the very few mid-sized global CROs with an in-house Scientific and Regulatory Affairs team delivering cross functional streamlined processes, and rapid and cost saving solutions.

AUSTRALIAN RAPID START-UP & 43.5% SAVINGS

Avance Clinical’s Australian operations can deliver Site Initiation Visit (SIV) and Study Start in 5 – 6 weeks. No IND is required. Indeed, more than 280 Phase III global trials conducted their Phase I in Australia . The 43.5% clinical trial rebate program can also extend to multi-regional later phases.

Latest News

4 June 2024

New Research Launched at BIO24 Finds CROs with In-house Regulatory Affairs Deliver 30% Savings, Halve Timelines and Cut Risk for Biotechs

• Company news

Avance Clinical is sharing new data at BIO 2024 from Frost & Sullivan research showing biotechs save more than 30% in costs and halve start-up times with CROs that have in-house scientific and regulatory affairs.

28 May 2024

Avance Clinical Expands Specialist CNS, Cardiometabolic, and Rare Diseases CRO Services in Europe with Julius Clinical

Avance Clinical has signed a Memorandum of Understanding (MOU) with Julius Clinical, a leading CNS and rare diseases specialist CRO with extensive site relationships in the region.

Avance Clinical Expands Further into APAC with New Clinical Operations in South Korea – Seoul Office Announced at BIO Korea 2024

Avance Clinical, the award-winning Australian and North American market-leading CRO for biotechs, will attend BIO Korea (May 8-10, 2024) and formally open new clinical operations in Seoul, South Korea.

Avance Clinical Welcomes Alex Kavros as Executive Vice President of Scientific & Regulatory Affairs

Avance Clinical, a leading Contract Research Organization (CRO) renowned for its innovative solutions in the biotech industry, is excited to announce the appointment of Dr Alex Kavros as the new Executive Vice President of Global Scientific & Regulatory Affairs.

Avance Clinical at World Vaccine Congress to Share Latest Vaccine Clinical Trial News Including an HIV-1 Study

• Conference news

Avance Clinical, the award-winning Australian and North American market-leading CRO for biotechs, will attend World Vaccine Congress in Washington DC (April 1-4, 2024) and share the latest clinical trial client news including the Uvax Bio announcement. (Booth #267)

16 April 2024

Introducing William Faria, the New Vice President of Biometrics at Avance Clinical

• New team members

Avance Clinical proudly welcomes William Faria as its new Vice President of Biometrics. With an extensive background in data management within the biometrics sector, William brings a wealth of experience and a global perspective to his new role.

Proven industry experience & expertise

Studies in the past 5 years

Experienced team members

Participants past 5 years

Years of CRO experience

The GlobalReady Contract Research Organization for Biotechs

Avance Clinical is a full-service Contract Research Organization (CRO) with clinical operations in Australia, New Zealand, Asia, North America, and Europe.

213 Glynburn Road Firle, South Australia Australia 5070

Phone: +61 8 8249 4788

View all locations

• Preclinical – ClinicReady
• Phase I / Early Phase
• Phase II+ / Late Phase
• The Australian Advantage
• The North American Advantage
• The Asia Advantage

Capabilities

• Our capabilities
• Clinical operations
• Data management
• Biostatistics
• Medical writing
• Quality assurance
• Patient Recruitment
• Global Scientific & Regulatory Affairs
• Global site partnership network
• Safety and Pharmacovigilance

Therapeutic areas

• Biotech experience
• Specialist areas
• Cell & gene therapies
• Central nervous system (CNS)
• Dermatology
• Endocrinology
• Infectious diseases
• Opthalmology
• Rare disease & orphan drug
• Respiratory & allergy
• Company overview
• Meet the team
• Working at Avance Clinical
• Industry awards

News & events

• Press releases

What are you looking for?

ClinicReady is your outsourced drug development department.

Popular searches: Preclinical, Phase I, Phase II, GlobalReady

Close search

• Company History
• International Friends
• Clinical Trial Design
• Clinical Trial Management
• Clinical Trial Monitoring Services
• CRF Design and Data Capture
• Data Management Services
• Medical and Scientific Writing Services
• Medical Monitoring and Pharmacovigilance Services
• Quality Control Processes and Auditing
• Statistics Services for Clinical Trials
• Statistics in Clinical Trial Preparation
• Data Conversion
• Statistical Analysis
• Oncology Clinical Trials Network
• Respiratory Clinical Trials Network
• Australian Cardiovascular Clinical Trials Network
• Australian Pain Clinical Trials Network
• Australian Neurological Clinical Trials Network
• Dermatology Clinical Trials Network
• Gastroenterology Clinical Trials Network
• Australian Metabolic Clinical Trials Network
• Early Phase
• Introduction to Clinical Research Course
• GCP Refresher Course
• Sponsor Responsibilities in Non-commercial Trials

AUSTRALIA'S ORIGINAL

Full service cro, intelligent, clinical trials, early phase, early phase clinical trials.

• Want a CRO with connections to all Phase I units in Australia?
• Need a customised phase I clinical trial in a specific hospital setting, and PK calculations and analyses for bioavailability and bioequivalence studies?
• Datapharm has conducted over 50 phase I clinical trials, and is ready to assist you!
• Do the Phase I clinical trial unit tour!

UP TO 43.5% OFF R&D INCENTIVE

• Are you eligible for up to 43.5% refund on your next Clinical Trial?
• Datapharm Australia is a registered Research Service Provider (RSP) with AusIndustry.  Find out more…
• What are the benefits of using a RSP?
• 43.5% “cash back” benefit now available for eligible foreign companies undertaking R&D in Australia

LATE PHASE CLINICAL STUDIES

• Need phase III clinical trial support in Australia and New Zealand?
• Want to run phase IV post-marketing & observational studies in Oceania?
• Datapharm Australia has well developed clinical trial site networks in various therapeutic areas to get late phase studies running quickly.
• Extending multicentre clinical research studies internationally?

Conducting Wound Healing Clinical Trials in Australia

In Australia, there are more than 450,000 people suffering from chronic wounds each year1. Chronic wounds can have a significant negative impact on the lives of patients and

Conducting Inflammatory Bowel Disease Clinical Trials in Australia Part 2

What to consider when designing an IBD clinical trial Inflammatory Bowel Disease (IBD) is a collective term for two chronic, autoimmune diseases of the gastrointestinal

Conducting Inflammatory Bowel Disease Clinical Trials in Australia Part 1

Inflammatory Bowel Disease (IBD) is a collective term for two chronic, autoimmune diseases of the gastrointestinal tract: ulcerative colitis (UC) and Crohn’s disease (CD). UC

Australia's Original Full Service CRO

Datapharm has earned an enviable reputation for detail and quality through involvement in hundreds of clinical trials in all phases (Phase I to IV) for clients ranging from large international pharmaceutical companies to local and international biotechnology companies, device manufacturers, producers of alternative therapies, private, hospital and university based investigators.

Clinical Trial Services

Datapharm is Australia’s original full service contract research organisation (CRO) providing clinical trial services such as Clinical Trial Site Selection, Regulatory and Site Set-up, Clinical Trial Monitoring Services, Data Management, Statistics, Medical and Scientific Writing, Medical Monitoring and Pharmacovigilance, Quality Control Processes and GCP Auditing.

Clinical Research Therapeutic Expertise

With over 35 years of experience, Datapharm has proudly managed clinical research across all phases and most therapeutic areas for both early phase clinical trials and late phase studies. Datapharm has relationships with some of the best clinical trial Investigators and study sites in Australia and New Zealand. Read more about Datapharm’s clinical trial therapeutic area experience.

Clinical Trial Management Speciality

Our clinical trial Sponsors’ budgets are managed using Project Advantage® and Project Status Invoicing which present project phases by work category against estimated and actual time and cost. As part of our service to you our project managers will work with timelines for data analysis to meet prearranged presentations to client boards or funding agencies. Datapharm Australia CRO clinical trial management services include clinical trial design, preparation of all necessary clinical trial documents, clinical site monitoring, data management, statistical services and medical monitoring and pharmacovigilance.

Testimonials

What are the advantages of running trials in australia, learn more by downloading the free ebook.

Advancing medicine, improving lives.

Do you want to be reimbursed up to $600/day for your time? Participate in one of our clinical trials and help to develop new medication that can help the lives of millions of people!

Discover our current studies

We have a wide variety of studies, ranging from stays of 2 days/nights to stays of multiple weeks. We are looking for healthy volunteers, but also people with a variety of medical conditions. Take a look at our current studies and find the one that's best for you!

Do you have any questions?

At Nucleus Network we run early-stage clinical trials for some of the world’s leading pharmaceutical and biotechnology companies. Do you have questions about how clinical trials work or what it’s like to take part in one? We are always happy to speak to potential participants at 1800 243 733

Participating in a clinical trial

Do you want to know more about what it's like to participate in one of our trials? Just watch this short video!

Our Unique Offering

Nucleus Network is the only Phase 1 clinical research organization in the world to have Phase 1 facilities located in Australia and the USA. We are Australia’s largest Phase 1 clinical research organization and one of the few specialized units in the USA capable of delivering Phase 1 hepatic and renal clinical trials.

Nucleus Network is uniquely positioned to help administer your clinical trial with our four key advantages:

Specialization

Each of our Phase 1 facilities have focused areas of specialization and extensive internal and external capabilities to support the complex requirements of Phase 1 clinical trials.

Our Phase 1 facilities are supported by a highly trained and dedicated team of medical personnel (FRACP), including clinical pharmacologists, oncologists, nephrologists and infectious disease physicians.

Our Australian Phase 1 facilities are strategically co-located within prominent Hospitals and our USA Phase 1 facility benefits from co-locating within a Life Sciences and Biomedical Research Precinct.

The data generated from Nucleus Network is used to support IND and NDA regulatory filings for the USA FDA. Data is also used for EMA, PMDA and Health Canada regulatory filings.

In excess of

Phase 1 clinical trials conducted

Annually conducting

Clinical Pharmacology trials across three clinics

true first-in-human studies completed annually

years’ experience conducting Phase 1 clinical trials

Phase 1 clinical trial beds

Hosted over

sponsor audits, including FDA and EMA regulatory inspections

Access to over

total population across Brisbane and Melbourne (Australia)

total population across Minneapolis – Saint Paul (USA)

qualified participant database

Conduct your clinical trial with us

In the spirit of reconciliation Nucleus Network acknowledges the Traditional Custodians of country throughout Australia and their connections to land, sea and community. We pay our respect to their Elders past and present and extend that respect to all Aboriginal and Torres Strait Islander peoples today. We acknowledge their contributions to medicine, science and public health.

© Copyright Nucleus Network

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A full service Contract Research Organization

155 Bovet Road, Suite 660, San Mateo, CA 94402

Your success is realized by our people working in highly functioning teams through trust, effective communication and proactive planning. This type of culture leads to success with your clinical trials.

InClin Services

InClin is a full-service Contract Research Organization with offices in the San Francisco Bay Area and Sydney, Australia. We believe that finding new treatments for diseases improves the quality of life for millions of people around the world.

In helping those in need, we can help make the world a better place to live. Our goal is to partner with drug development sponsors with similar ideals to develop new and improved life changing therapies.

Our Biometrics Department, comprised of Data Management, Statistical Analysis and Programming support provide an integrated and comprehensive approach to clinical development.

Strategic Consulting

InClin provides strategic consulting on planning and execution of clinical trials including experimental design and program optimization.

Quality Assurance

InClin has Quality Assurance professionals with expertise in Inspection Readiness gap assessment and risk mitigation strategic consulting.

Medical Monitoring

Inclin has a team of medical experts to provide strategic consulting and medical monitoring in several therapeutic indications.

Clinical Operations

InClin provides clinical operations services that cover Phase 1 to 4 clinical research activities. InClin’s clinical operations team is experienced and has expertise in multiple therapeutic areas.

Medical Writing

The value of using InClin’s skilled medical writers is the production of high-quality documents in less time than is usually built into timelines.

Drug Safety

InClin has an experienced drug safety team to provide safety-related services for investigational new products undergoing evaluation during clinical research activities.

Founded in 2010 and headquartered in Australia, Southern Star Research is a full-service clinical research organisation (CRO) helping sponsors to navigate the complexities of bringing new medical products to market. Since commencing operations in Sydney, we have grown to become an international team of specialists, managing studies across the globe.

With a focus on the biotechnology and medical device industries, we offer flexible and bespoke solutions that meet the unique needs of each project. While we have experience across all study phases, we are early phase specialists (Phase 1 and 2) with particular expertise in designing and managing clinical trials that ensure your asset is ready for larger Phase 3 and 4 studies, licensing, partnering and acquisition.

We believe a customer-first approach, transparent relationships and a proactive team of experts are the best path to achieving successful commercial outcomes for our clients.

Get in touch now to discuss how our agile and dedicated team can help you run a successful clinical trial.

Our Leadership team

Our partnerships.

Our mission is to help sponsors bring safe and effective medicines and products to market in an efficient and streamlined way.  We believe in:

Agile, proactive and bespoke solutions that help you reach your commercial goals faster

The very best quality at a predictable price - no unexpected add-ons

Transparent, close relationships, with a focus on your unique needs

Simplifying the clinical trial process – we’ll help you navigate each stage with confidence

• Professionalism
• Honesty & integrity
• Excellence in customer service
• Focus on timelines and budget
• Agility & flexibility
• Dependability
• Spirit of altruism
• Commitment to exceeding expectations

Our work in the community

request a proposal

“What a stellar job you’re doing with the SAD study – so calm, confident and professional. In my 30+ years training and managing project managers you stand out by far as one of the best I have seen. I am proud to have you as part of our team.”

Phase 1 study, local Biotech company

“Thank you, your professional attitude and constant support are much appreciated.”

CEO, Australian Medical Device Company

“Their expertise is second to none, they are on the ground working with sites intimitely with close attention to detail to ensure that the job gets done. With Southern Star you dont feel like you’re dealing with big organisation – you get a face to face personal approach.”

Director of Regulatory Affairs

“SSR take time to find out how we work and are solutions focused suggesting things that might help our business. They invest in great outcomes and are willing to think about the long term relationship and how they might work better with their partners.”

Head of Trial Management & Monitoring

“Working with Southern Star Research gives us a level of security, you know your trial will be delivered as expected without surprises. Communication is easy and they are flexible, we talk through issues and adapt continuously to fine tune and tailor to what we need.”

Clinical Trials Program Manager

• Phone: +61 (0)2 9011 6266
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OZTRIALS CLINICAL RESEARCH

We are a private, independent clinical trial research site formed to conduct phase II-IV clinical trials in various therapeutic areas, based in Sydney’s Inner West (Drummoyne).

Our mission is to provide clinical  trial participants with excellent medical care, and provide Sponsors with the highest quality research services.

• For Patients

Participating in clinical trials can be very rewarding for the individual and also supports the search for improved and new medicines.

If you are interested in finding out about clinical trials which may be relevant to you or a loved one, please get in touch with us to find out about our current and upcoming studies.

Find out more about our currently enrolling clinical trials here…

• For Sponsors

Oztrials is a private clinical research unit setup to assist clinical trial Sponsors with their pipeline goals.

Oztrials Clinical Research can offer support with clinical trial HREC submissions,  Patient Recruitment, Site Management through to project completion in various therapeutic areas.

Contact us today for clinical trial feasibility, and to discuss your next project needs!

Oztrials welcomes constructive collaborations with local and international Contract Research Organisations (CROs), other research sites, Institutes & Non-profit groups, Site Management Organisations (SMOs), medical professionals, external labs, Universities and beyond to work together on clinical trials projects conducted to Australian TGA annotated ICH GCP (Good Clinical Practice) guidelines and the National Statement on Ethical Conduct in Human Research .

PATIENTS' FREQUENTLY ASKED QUESTIONS

Clinical trials are research investigations in which people volunteer to test new treatments, interventions or tests as a means to prevent, detect, treat or manage various diseases or medical conditions. Some investigations look at how people respond to a new intervention* and what side effects might occur. This helps to determine if a new intervention works, if it is safe, and if it is better than the interventions that are already available.

Clinical trials might also compare existing interventions, test new ways to use or combine existing interventions or observe how people respond to other factors that might affect their health (such as dietary changes).

The World Health Organization (WHO) definition for a clinical trial is

‘ any research study that prospectively assigns human participants or groups of humans to one or more health-related interventions to evaluate the effects on health outcomes’ .

Clinical trial interventions include but are not restricted to

• experimental drugs
• cells and other biological products
• medical devices
• surgical and other medical treatments and procedures
• psychotherapeutic and behavioural therapies
• health service changes
• preventive care strategies and
• educational interventions.

Researchers may also conduct clinical trials to evaluate diagnostic or screening tests and new ways to detect and treat disease.

*The word ‘intervention’ will be used to refer to interventions, treatments and tests throughout this website.

New interventions that help people to live longer, have less pain or be free of disability are only possible because of the willingness of people to participate in clinical trials. Both healthy participants and those diagnosed with a disease or condition are needed to help find new ways to diagnose, prevent, treat or cure disease and disability. If more people are involved in clinical trials, it may reduce the time it takes to make new interventions widely available.

By taking part in a clinical trial, you can contribute to the advancement of scientific knowledge and, in some cases, to improved health for yourself or others with the same disease or condition.

Australia conducts internationally recognised high-quality clinical trials. Australian clinical researchers have a wealth of knowledge and expertise that is helping to improve health care both in Australia and around the world. Clinical research also improves our health care service by improving patient care practices.

WHY BE PART OF A TRIAL IF YOU ARE HEALTHY

Healthy people may choose to participate in order to help others, to contribute to improved health care or to contribute to the advancement of scientific knowledge. Sometimes they have a personal interest in the specific trial or they might have a friend or family member with the disease or condition.

Like any volunteer work, clinical trials can also be a way to give back to the community.

Although volunteering to help improve the lives of family, friends or others is an extraordinary gesture of kindness, potential participants should think carefully about the demands on their time and the risks and benefits (if any) before enrolling in a clinical trial.

WHY BE PART OF A TRIAL IF YOU HAVE A DISEASE OR CONDITION

Patient participants with a disease or condition may decide to participate in clinical trials to contribute to better understanding of, or better treatment or a potential cure for their disease or condition. In some cases, clinical trials can provide access to new interventions before they are widely available.

Trials also offer the hope of developing better interventions or tests for a particular disease or condition, so that even if a trial does not provide a benefit for an individual, it may provide benefits for others with the disease in the future.

As a patient participant, even when you receive the highest quality care, you may also benefit from additional support and attention provided by clinical trial staff who understand your disease or condition.

COPYRIGHT: © COMMONWEALTH OF AUSTRALIA 2014

This work is licensed under a  Creative Commons Attribution 3.0 Australia License

Source: National Health and Medical Research Council

For anyone interested in being part of a clinical trial, the first step is finding out more about trials in general and what is involved in a particular clinical trial. It is a good idea to seek out information from a number of sources.

There is a wealth of information available on this and other websites about clinical trials in general, why a person may want to be part of a clinical trial, the ethics and regulation of clinical trials in Australia and how to find a trial that is relevant.

WHO TO TALK TO

You can talk to any of the health professionals involved in your care — general practitioners (GPs), specialists, or nursing or allied health professionals. They should be able to provide general information about clinical trials and may have information on clinical trials that is relevant you.

Support groups or consumer health organisations with an interest in a particular disease or condition that you are interested in may also have information on trials, or be able to provide contact information for other patients who have been involved in trials.

QUESTIONS TO ASK

If you are thinking of being part of a clinical trial, you should know as much as possible about the trial and your involvement in it. You can discuss your questions with your doctor and with the research team. You may also find some of the answers to your questions in the participant information and consent form.

When you plan to discuss participation

• consider taking a family member or friend along for support and for help in asking questions or recording answers
• plan what to ask ahead of time, but don’t hesitate to ask any new questions that you think of while you’re there
• write down your questions in advance to make sure you remember to ask them all
• write down or record the answers, so that you can review them whenever you want
• remember that you can ask further questions to the team running the trial at any time
• remember that you can withdraw from the trial at any time and resume other treatment, if that is recommended.

HERE ARE SOME QUESTIONS THAT YOU MAY WANT TO ASK:

About the trial.

• What is the aim of the trial and how will it help people?
• Has the intervention been tested before and, if so, what was the outcome?
• Will the trial use a  placebo  (a ‘dummy’ treatment), standard care or another established intervention as  the control to compare with the new intervention?
• Who is funding the trial?

YOUR INVOLVEMENT

• How might this trial affect my daily life? How much of my time will be needed?
• What kinds of tests and experimental interventions are involved?
• Will I have to complete questionnaires or keep a diary?
• Will I need to spend time in hospital?
• Will I need to take time off work or school?
• Where will the trial be conducted and will I have to travel to be part of it?
• Will I be able to take my regular medications while participating in the trial?
• How long is the trial expected to last? How long will I have to be part of it?
• What will happen if I stop the trial intervention or leave the trial before it ends?
• Who will be in charge of my care? Who can I contact for support and information during the trial? Will someone be available 24 hours a day?
• What are the risks of taking part in this trial? What are the possible side effects of the trial intervention?
• How do the possible risks, side effects and benefits in the trial compare with my current treatment or care?
• If people receiving one intervention in the trial respond much better than people receiving the other intervention or standard care, will all participants be given access to the more effective intervention?
• Who will pay for the experimental intervention?
• Will I be paid to participate in the trial?
• Will my expenses be covered?
• If there are complications that arise from the trial, who is responsible for paying for any costs that are associated with them?

AFTER THE TRIAL

• What follow-up care is available after the trial?
• How long will it be before the results of the trial are known?
• How do I find out the results of the trial?
• Will I have access to the experimental intervention after the trial if I wish to continue with it?

Download these questions as a PDF (PDF, 253KB)

WHAT OTHERS ARE SAYING

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There is an ongoing need for well-conducted clinical studies to collect high quality safety and efficacy data.

Access to patients for inclusion into trials is vital to ensure rapid recruitment of study subjects. The data generated need to be robust for product registration, but also generalisable from a representative sample of subjects in the appropriate clinical setting. At AusTrials we are dedicated to scientific discovery and committed to caring for all our participants.

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AusTrials is a leading private clinical trial site, operated by an experienced team of medical officers and study coordinators. We work with pharmaceutical companies, contract research organisations and academic research institutes to make clinical trials available to patients.

Our long history in Australian clinical trials as ACRO was continued in 2009 with the merger with Trialworks and the creation of AusTrials.

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We work with pharmaceutical companies, contract research organisations and academic research institutes to make clinical trials available to patients.

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At Clinexa, we are continuously looking for new ways to pass value back to our clients. We thrive in a culture of challenging ourselves and our partners so that clinical trials are conducted with the highest quality, compliance, and speed but at a cost that is affordable and commensurate to the services we offer to our clients.   

We are fully responsive to the unique needs of clients and work closely with all partners with shared responsibility to provide comprehensive and meaningful solutions.

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Clinical trials management, non-industry sponsored, early cro engagement is key for success.

At Clinexa, we offer meaningful solutions from preclinical to regulatory applications, program development, marketing approval, and post-marketing research. Our expertise spans across multiple therapeutic areas, phases of clinical trials, special areas such as vaccines, biologics, and diagnostics. ”

At Clinexa, we believe in being resourceful and deliver the best value and experience to our clients and partners.

Personalization, proactivity, convenience, our teams offer deep experience in managing clinical trials.

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Clinexa has over a decade of rich and diverse experience in conducting clinical trials in the Asia Pacific region

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Our team has a combined experience of over 500 clinical trials across all phases and therapeutic areas.

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We have successfully served clients of all sizes from large pharma and biotech to start-up companies.

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Your trusted clinical research partner, every step of the way

Unique, full-service CRO, embedded in one of the world’s largest global oncology networks

Who are we?

GenesisCare’s Clinical CRO is an independent company within GenesisCare, providing contract clinical research services. As a global full-service CRO, we provide tailored clinical development solutions spanning the entire lifecycle of product development, with deep expertise in oncology and theranostics. Leveraging the expertise of our global physician and site network, we deliver faster, more cost-effective and efficient trials for clinical development for our customers.

Our unique, integrated CRO and SRO network model, translates into:

• Access to a large patient population and information on patient availability, for study feasibility & site selection 
•  Access to global site network, facilitating improved patient recruitment & retention.
• Improved investigator and site engagement - Key opinion leader input into study design & reporting
• Access to Real World Data & patient registries 
• Direct to site communication and transparency

How we partner

GenesisCare’s Contract Research Organisation is an independent company founded by GenesisCare. We provide tailored bespoke services across all clinical trial phases for our customers.

One of the key benefits of our network is that we can provide customers with a fully integrated solution, comprising of our CRO, SRO and Imaging Research Organisation (IRO). However, as a Contract Research Organisation and Imaging Research Organisation, we are site and company agnostic, and also work routinely with other site research organisations, academic institutions, and hospital networks. Our Site Research Organisation is also CRO agnostic and can also work with other CRO’s.

Strategic Clinical Development Consulting

Deep and broad expertise in planning therapeutic development pipelines and operationalising protocols. Our consulting services start the very first day you engage us on a potential project. We are able to provide the relevant input, in-country knowledge, and expertise to enable our customers to execute the right protocol strategy for their projects.

Project Management

We provide start-to-finish project management services for clinical studies to drive operational efficiencies and maintain patient safety and data integrity. Our dedicated team of project managers will become your key contact throughout all stages of the project and will be deeply embedded in your team. We provide a complete 360 project management solution, including all aspects of status reporting, budget, third-party vendors and milestone management.

Data Management

Accurate and reliable clinical data allows us to assess whether a study’s primary and secondary endpoints have been achieved and is also the key component of any application for regulatory approval.  We look to take data management off the critical path with an innovative and agile approach to cater to different protocol complexities. We work with industry standard electronic data capture (EDC) platforms, including Veeva EDC and Viedoc EDC.

Our flexible clinical data management solution includes:

• Database design and development
• Provision of CDISC/SDTM compliant datasets
• Medical coding
• Data transfer and API integrations
• Query design and validations
• Preferred EDC platforms
• Data reconciliation (including SAE reconciliation)
• De-identification of data
• Study status Reporting

Site Management and Engagement

Our philosophy and approach to clinical trial site management and engagement isn’t like your typical CRO. Our integrated site research network, spanning more than 350 centres across the globe, gives us a unique, fresh perspective on site management. We understand the very real, practical challenges faced by trial sites and on-the-ground teams, and anticipate and resolve potential roadblocks before they arise.

Our services include:

• Investigator recruitment and ongoing engagement
• Site identification and feasibility studies, site selection and qualification
• Site Initiation
• Site personnel training and education 
• Management of patient recruitment
• Therapeutic supply logistics
• Monitoring of clinical trial data
• Direct-to-site communication

Quality Assurance

GenesisCare’s highly experienced global Quality Assurance team has deep and broad experience in all areas of quality assurance and knowledge of GCP guidelines and in-market local regulations.  To ensure a seamless integration with our customers own QA systems and processes, we have invested in a quality management system routinely used by pharmaceutical, biotech, and medical device companies, and we are ISO9001 certified. Our QA service offering includes clinical site, protocol and clinical database audits, as well as providing support to our clients for regulatory bodies inspections.

Pharmacovigilance

At GenesisCare, our global team of Pharmacovigilance (PV) experts manage the safety and pharmacovigilance needs of clients throughout all stages of product development.

Our PV services for Phase I-III development include:

• SAE reporting
• SAE processing
• Narrative writing
• Medical review
• Lab and diagnostics test review
• Safety report distribution and submission
• Expertise in all major systems

Our PV team work with industry standard platforms to manage case reporting, including the TARA PV platform.

Biostatistics

GenesisCare partners with leading biostatistics service providers, who work in close collaboration with the data management and project management teams throughout all stages of a study.

Our services include sample size estimation and review of methodology, statistical analysis, rapid data delivery, access to all compatible data formats and files, and clinical study report delivery.

Medical Writing

We offer end-to-end clinical research communication services, built from a comprehensive understanding of in-country regulatory guidelines and scientific communication expertise.

Our medical writers work closely with other key functions, including Biostatistics, Quality Assurance, and Clinical Operations, to ensure timely and efficient information transfer.

Our medical writing services include:

• Regulatory: writing and submissions
• Clinical study protocols and amendments
• Informed consent writing 
• Publications and abstracts
• Investigator educational material
• Clinical study report writing

Imaging Research Organisation:

GenesisCare’s CRO is home to a dedicated Imaging Research Organisation (IRO), specialising in the provision of comprehensive imaging services to support oncology and theranostics research. Our IRO services include full-service central imaging, comprehensive nuclear medicine consultancy and dosimetry services for radiopharmaceutical development.  

GenesisCare’s IRO offers clients end-to-end tailored imaging and dosimetry services throughout all stages of the clinical trial process for oncology and theranostics research:

• Bespoke imaging and dosimetry consultation for protocol writing
• Imaging Manual and Charter Preparation
• Site and Reader selection and training
• Streamlined image receipt, QC and query resolution
• Imaging quantification and dosimetry
• Central image review across all imaging modalities, including PET, SPECT, CT, MRI

We understand the importance of imaging protocol and its criticality in meeting imaging endpoints. GenesisCare’s IRO provides clients with imaging protocols tailored to the need of each trial for image quality optimisation and standardisation across multiple sites. Key services include

• Site Imaging Manual preparation and site training
• Optimisation of PET/CT   and SPECT/CT image acquisition and reconstruction
• Scanner validation for diagnostic and therapeutic trials
• Extensive experience with diagnostic and therapeutic radionuclides

With our team of experienced technologists and physicists, GenesisCare’s IRO are the experts in image quantification and dosimetric calculations for radiopharmaceutical development. Key services include:

• Vendor-neutral SPECT image reconstruction and quantification 
• Dosimetry based on 2D planar, 3D SPECT/PET or hybrid 2D-3D imaging 
• MIRD style phantom organ S-values methodology  
• Voxel S-values methodology for patient-specific dosimetry 
• Biological equivalent dose (BED) modelling for radiopharmaceuticals
• Extrapolation of dose from surrogate to therapeutic radionuclides

We understand the importance of central image reviews for imaging endpoints in oncology and theranostics trials where imaging is involved. GenesisCare’s IRO provides clients bespoke central imaging services that include:

• Image Review Charter preparation, reader selection and training
• Central image reads by experienced Nuclear Medicine Physicians and Radiologists for imaging endpoints 
• Expert advice from experienced clinical trialists for central read design

Our experienced team of physicians, physicists and technologists, provide comprehensive theranostics technical support and have extensive experience with development of diagnostic and therapeutic radiopharmaceuticals. We provide guidance and advice on current best practices for theranostics trials.

Our partner promise:

Since our inception in 2018, we have become a trusted partner of choice to pharmaceutical, biotechnology, medical device sponsors, as well as leading academic institutions and tertiary hospitals.

We believe great things happen for our patients when like-minded organisations come together to innovate, collaborate, and shape the future of cancer care.

Our networked nimble approach to clinical research allows us to provide tailored solutions to meet the needs of each individual sponsor.

We are committed to operational and clinical excellence throughout all stages of drug development.

Rapid clinical trial build

Accelerated patient recruitment, dedicated support team, multi-region system integration, access to unique proprietary real-world data tools, global standardised quality governance framework, get in touch:.

If you are interested in partnering with GenesisCare’s CRO to drive your clinical research, please contact us today by emailing us, or alternatively, you can complete the below contact form.

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Awareness Through  Research

Call for study enquiries:   +61  8 9448 7376

Clinical Research Australia is a contract research organisation located in Perth, Western Australia.

We specialise in conducting clinical trials on natural treatments to enhance mental and physical well-being

Our Mission Statement

“To provide an efficient, ethical, and high-quality research service that supports the continued growth of the nutraceutical industry and builds trust with consumers."

"We strive to develop personalised, long-lasting, and mutually-beneficial relationships with our trial sponsors, with the goal of contributing to their success.”

All our clinical trials are conducted in accordance with the:

• Guidelines for Good Clinical Practice (CPMP/ICH/135/95)
• National Statement on Ethical Conduct in Human Research
• Declaration of Helsinki
• Australian Code for the Responsible Conduct of Research, 2018

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Regulatory Authority

Scope of assessment, regulatory fees, ethics committee, scope of review, ethics committee fees, oversight of ethics committees.

Clinical Trial Lifecycle

Submission Process

Submission content, timeline of review, initiation, agreements & registration, safety reporting, progress reporting.

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Site/investigator selection, insurance & compensation, risk & quality management, data & records management, personal data protection.

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Definition of Investigational Product

Manufacturing & import, quality requirements, product management, definition of specimen, specimen import & export, consent for specimen, requirements, additional resources.

Clinical Trials Registries

• ClinicalTrials.gov listing of studies in Australia
• International Clinical Trials Registry Platform (ICTRP) consolidated listing of studies in Australia

Ethics Committees

• Database of institutional review boards/ethics committees registered with the United States Department of Health and Human Services (HHS) Office for Human Research Protections (OHRP) 

Funding & Institutions

• World RePORT database of funding organizations, research organizations, and research programs in Australia
• HHS OHRP database of institutions with approved Federalwide Assurances (FWAs) for the protection of human subjects

Australia Profile Updated

Australia profile updated with revised tga contact information, australia profile updated with revised tga fee schedule, australia profile updated with revised fees document, australia profile updated with revised fees document and gcp inspection guidance, australia profile updated with governance framework implementation details, australia profile updated in clinregs, australia: ctx scheme renamed cta scheme, australia: health agencies issue joint guidance regarding clinical trials and covid-19.

Other Regulatory Databases

• United States Department of Health and Human Services (HHS) Office for Human Research Protections (OHRP) International Compilation of Human Research Standards for Australia
• Health Research Web - Australia

Therapeutic Goods Administration

As per the TGAct , the TGR , and the G-CTHandbook , the Therapeutic Goods Administration (TGA) is the regulatory authority responsible for clinical trial approvals, oversight, and inspections in Australia at the national level. The TGA allows for the supply of unapproved therapeutic goods to be used in clinical trials for experimental purposes in humans in accordance with the provisions in the TGAct and the TGR . There are two (2) regulatory schemes for supplying unapproved therapeutic goods in clinical investigations, which are more fully examined in the Scope of Assessment section .

As per AUS-28 , the TGA is part of the Health Products Regulation Group (HPRG) within the Australian Department of Health and Aged Care . According to the G-TrialsSOP and AUS-32 , the TGA regulates the supply, import, export, manufacturing, and advertising of therapeutic goods. Per AUS-31 , therapeutic goods include prescription medicines, vaccines, sunscreens, vitamins and minerals, medical devices, blood, and blood products.

The TGA manages the Australian Register of Therapeutic Goods (ARTG) ( AUS-22 ), a public database of therapeutic goods that can be legally supplied in Australia. According to the TGAct , the TGA grants exemptions from inclusion in the ARTG for unapproved therapeutic goods to be supplied in clinical trials.

Contact Information

Per AUS-23 and AUS-47 , the contact information for the TGA is as follows:

Postal Address: P.O. Box 100 Woden ACT 2606 Australia

For general questions:

Phone: 1 800 020 653 (free call within Australia) or +61 2 6289 4124 (international calls) Fax: 02 6203 1605 E-mail: use online form (see AUS-11 )

For clinical trial questions:

Phone: Same as the general questions numbers E-mail: [email protected]

In accordance with the G-CTHandbook , the G-TrialsSOP , and AUS-47 , the Therapeutic Goods Administration (TGA) allows for the supply of unapproved therapeutic goods to be used in clinical trials under two (2) regulatory schemes—the Clinical Trial Notification (CTN) scheme and the Clinical Trial Approval (CTA) scheme. The G-CTHandbook specifies that the scope of the TGA’s assessment includes all clinical trials (Phases I-IV).

Under either regulatory scheme, per the TGR , the G-CTHandbook , the G-TrialsSOP , and AUS-47 , an ethics committee (EC) (Human Research Ethics Committee (HREC) in Australia) must approve the research protocol. The G-NatlStmt further specifies that any research that involves greater than low risk must be reviewed by an EC.

According to AUS-40 , all public and private health organizations must also undertake a site-specific assessment (SSA) of each research project. This allows the institution to consider whether the project is suitable for the site and whether it has the capacity to conduct the research at that site. Per the G-TrialsSOP , the SSA and ethics review may occur in parallel. However, EC approval must be obtained and submitted to the research governance officer (RGO) of each participating institution before institutional authorization is granted.

For summaries of the clinical trials regulatory environment, legislation, and guidance, see AUS-40 .

Clinical Trial Review Process

Per the G-CTHandbook , the sponsor is responsible for the overall decision as to whether the CTN or CTA scheme should be used. Consulting the EC responsible for protocol approval may assist the sponsor in making the decision. The main difference between the CTN and CTA schemes is the TGA’s level of involvement in reviewing data about the therapeutic goods before the clinical trial commences.

See AUS-27 for more information on choosing a clinical trial scheme.

As per the G-CTHandbook , the G-TrialsSOP , and AUS-47 , under the CTN scheme, the sponsor must notify the TGA of its intention to sponsor a clinical trial involving an unapproved therapeutic good. The TGA does not assess any data relating to the proposed trial at the time of submission. As further indicated in AUS-47 , sponsors may submit the CTN to the TGA concurrently with the EC’s and institution’s review and approval/authorization. However, it is the sponsor’s responsibility to ensure that all relevant approvals and authorizations are in place before commencement of the trial.

The G-CTHandbook indicates that a clinical trial is deemed to be notified as soon as the online CTN form (via the TGA Business Services (TBS) webpage ( AUS-36 )) has been submitted and the relevant fee has been paid. If there are any changes to the trial details notified to the TGA (such as a change in the details of the principal investigator (PI), the address of the site, or the therapeutic good), the sponsor must update the relevant fields on the online CTN form.

The G-CTHandbook further states that the TGA may request additional information if the trial raises any concern, or ask specific questions to address any deficiencies. Specifically, the TGA can request certain information or documents from the sponsor relating to the supply and handling of the goods, as well as the monitoring and results of the supply of the goods. If the TGA directs a trial notified under the CTN scheme not to be conducted or becomes aware that conducting or continuing the trial would be contrary to the public interest, then the goods used in the trial would no longer be exempt from inclusion in the Australian Register of Therapeutic Goods (ARTG) ( AUS-22 ) and cannot be lawfully supplied. This may occur if the TGA becomes aware that allowing the trial to proceed or continue carries an unacceptable risk of death, serious illness, or serious injury.

According to AUS-47 , parties that are considering submitting a CTA application are strongly encouraged to contact the TGA at [email protected] for advice regarding the application process (some class IV biologicals must be submitted under the CTA scheme). Pre-submission meetings with the TGA may be requested through the forms found on AUS-17 .

AUS-47 indicates that the CTA scheme consists of a two (2)-part process. Part 1 constitutes the formal CTA application, which the sponsor completes and submits directly to the TGA. Part 2 requires the sponsor to notify the TGA when a trial commences and alert the TGA to new sites in ongoing CTA trials.

As per the G-CTHandbook , the TGA reviews relevant, but limited, scientific data, and its primary responsibility is to review the safety of the product. In addition, the TGA can request certain information or documents from the sponsor about therapeutic goods approved under the CTA scheme relating to the supply and handling of the goods, as well as the monitoring and results of the supply of the goods.

AUS-47 further specifies that the evaluation of a CTA application includes consideration of the manufacturing and quality and safety data in conjunction with the trial's usage guidelines, to inform a risk-benefit decision by the TGA on whether or not to approve the clinical trial. Any significant changes to the information provided in support of the trial are considered a variation and need to be approved, since they have the potential to affect the initial decision to approve a trial. The TGA advises clinical trial sponsors to contact them via [email protected] if they intend to change a previously approved CTA application.

The G-CTHandbook further states that the TGA can revoke an approval of a clinical trial under the CTA scheme where the conditions of approval are not met.

According to the G-GCP-Inspect , clinical trials of medicines and biologicals regulated under the CTN or CTA schemes are subject to the TGA’s Good Clinical Practice (GCP) Inspection Program. See the G-GCP-Inspect for more details on how the TGA prioritizes and schedules GCP inspections, the kinds of inspections the TGA might conduct, the inspection process, and how the TGA reports and follows up on inspections. Additionally, see AUS-59 for frequently asked questions about the GCP Inspection Program.

As per the TGR , the sponsor is responsible for paying a fee to the Therapeutic Goods Administration (TGA) to submit an application under the clinical trial notification (CTN) or clinical trial approval (CTA) scheme for evaluation. Per the G-FeesCharges , the fees are as follows:

• $410 Australian dollars for unapproved medicines CTN, and for each notification of one (1) or more additional trial sites
• $1,954 Australia dollars for unapproved medicines CTA (30-day evaluation)
• $537 Australian dollars for unapproved medicines CTA – variation (30-day evaluation)
• $24,285 Australian dollars for unapproved medicines CTA (50-day evaluation)
• $6,628 Australian dollars for unapproved medicines CTA – variation (50-day evaluation)
• $410 Australian dollars for unapproved biologicals CTN, and for each notification of one (1) or more additional trial sites
• $29,574 Australian dollars for unapproved biologicals CTA
• $8,069 Australian dollars for unapproved biologicals CTA – variation

According to AUS-47 , a higher fee is applicable to clinical trial applications under the CTA scheme due to the more complex nature of the evaluation process. Certain variations to an existing CTN may incur a fee, such as the addition of a new site, change to a previously notified therapeutic good that creates separate and distinct goods, or the addition of a new therapeutic good to a previously notified trial. For additional fee information, refer to Schedules 9 and 9A of the TGR and the G-FeesCharges .

Payment Instructions

AUS-66 indicates that regulatory fees and charges may be paid online or by bank transfer (electronic funds transfer (EFT)). Online payment by credit card is the preferred payment option, and all payments must be in Australian dollars.

As stated in AUS-25 , online payment is made via the TGA Online Payment Portal ( AUS-16 ). Once the payment has been finalized, the Portal will confirm that the payment has been successful. The user may request an email confirmation. Certain payments, including a CTN fee and a variation to a medicine (e.g., a therapeutic good), may be made online without an invoice. See AUS-25 for more information.

AUS-66 further indicates that to ensure all payments made by EFT are correctly allocated, the organization’s Identification Number (e.g., TGA00xxxxx) should be included in the payment ‘Reference’ field. Bank transfer fees are the payer’s responsibility. Additionally, bank transfers must be accompanied by a remittance advice, which must be issued within 24 hours for all bank transfers. Remittance advices must be emailed to [email protected] and contain the organization’s Identification Number in the subject field. The TGA’s bank account details are as follows:

Bank: Commonwealth Bank of Australia BSB: 062-909 Account Number: 10215498

Per AUS-66 , payments from overseas can only be accepted in Australian denominations. Payers must ensure that their payment covers any international banking fees. The TGA’s international banking details are as follows:

IBAN: 06290910215498 Swift Code: CTBAAU2S

As indicated in the TGAct , the TGR , the G-CTHandbook , the G-NatlStmt , and AUS-47 , Australia has a decentralized process for the ethics review and approval of clinical trial research. According to the TGR , the G-CTHandbook , the G-TrialsSOP , and AUS-47 , Australia requires human research protocols to be reviewed by an institutional-level ethics committee (EC). The G-NatlStmt further specifies that any research that involves greater than low risk must be reviewed by an EC. (Note: Institutional ECs are referred to as Human Research Ethics Committees (HRECs) in Australia.)

The G-NatlStmt indicates that one (1) or more institutions can individually or jointly establish an EC or any other ethics review body. Institutions that establish an EC are responsible for adequately resourcing and maintaining it, including providing sufficient administrative support. Per the TGAct and AUS-20 , ECs are required to be constituted and operate in accordance with the guidelines issued by the National Health and Medical Research Council (NHMRC) , and to have notified the NHMRC of their existence. According to the TGR , the G-NatlStmt , the G-TrialsSOP , and AUS-20 , institutional ECs ensure that clinical trial research complies with the NHMRC’s ethical standards published in the G-NatlStmt . See the Oversight of Ethics Committees section for more information on notification.

Ethics Committee Composition

As stated in the G-NatlStmt , an EC must be composed of at least eight (8) members in the following categories:

• A chairperson with suitable experience
• Two (2) people who bring a broader community or consumer perspective and have no paid affiliation with the institution
• One (1) person with knowledge of and current experience in the professional care, counseling, and/or treatment of people
• One (1) person who performs a pastoral care role in the community
• One (1) qualified lawyer, who may or may not be currently practicing and, where possible, is not engaged to advise the institution on research-related or any other matters
• Two (2) people with current research experience relevant to the research proposals to be considered at the meetings they attend

The G-NatlStmt further states that wherever possible, one (1) or more of the members listed above should be experienced in reflecting on and analyzing ethical decision-making. As far as is practicable, institutions should ensure that their EC’s membership at each meeting has diversity, including gender diversity, and at least one third of those participating in each meeting are from outside of the institution. ECs that review research about Aboriginal and Torres Strait Islander people or communities should appoint one (1) or more members who have knowledge of research with Aboriginal and Torres Strait Islander peoples or are familiar with relevant cultural knowledge, if such a person has not already been appointed.

Per the G-NatlStmt , ECs may also include other members with the above areas of expertise or with additional areas of expertise. Institutions are encouraged to establish a pool of appointed EC members to draw on as needed to help meet minimum membership requirements and/or provide additional experience or expertise. The institution should ensure that its EC has access to the expertise necessary to properly review research, which may necessitate going outside of the EC’s membership.

Terms of Reference, Review Procedures, and Meeting Schedule

As delineated in the G-NatlStmt , institutional ECs must ensure that it documents, implements, and publicizes standard operating procedures (SOPs) that promote good ethics review, including:

• Meeting frequency, attendance, and conduct
• Minutes and agenda preparation
• Timely distribution of materials to members before meetings
• Timely consideration of applications
• Methods of deliberation and decision-making
• Processes, if any, for reviewing applications from unaffiliated or international researchers
• Disclosure of interests and management of conflicts of interest
• Appropriate confidentiality of the content of applications and the deliberations of review bodies
• Prompt notification of decisions to researchers
• Communicating with researchers, including face to face, by telephone and in writing, (including available forms of electronic communication)
• Record keeping
• Monitoring of approved research
• Reporting and handling of adverse events
• Receiving and handling of complaints
• Advising the institution(s) of decisions to suspend or withdraw ethics approval of research projects
• Attendance of people other than members at meetings

Pursuant to the G-NatlStmt , EC members should be familiar with the G-NatlStmt and other relevant guidelines; prepare for and attend EC meetings or, if unavailable, provide opinions before the meetings; and attend research ethics training programs or continuing education at least every three (3) years. Members should be appointed to an EC using open and transparent processes, and institutions should consider reviewing appointments to the EC at least every three (3) years.

The G-NatlStmt states that as far as possible, each EC meeting should be arranged to enable attendance of all members of the minimum membership categories listed above and other relevant appointed members, either in person or via available technology. Meeting papers should be provided enough in advance to enable members to be fully informed. An EC’s decision about whether a research proposal meets the requirements of the G-NatlStmt must be informed by an exchange of opinions from all members of the EC participating in the meeting. The exchange should, ideally, take place at a meeting with all those members present. Where there is less than full attendance of the minimum membership categories at a meeting, the chairperson must be satisfied, before a decision is reached, that the views of those absent who belong to the minimum membership have been received and considered. The EC should attempt to reach decisions by general agreement or consensus. Voting is neither required nor prohibited. Some decisions may not be unanimous, and a dissent should be recorded in the minutes of the meeting. Where requested by a dissenting member, the reasons for the dissent should also be recorded in the minutes of the meeting.

According to the G-NatlStmt , ECs may invite researchers, and researchers may request, to be present for discussion of their proposed research. In addition, ECs may seek advice from external experts to help in considering a research proposal. Communication between the sponsor and the EC is not prohibited but should be restricted so that it does not inappropriately influence the review of any relevant research proposals.

As delineated in the G-NatlStmt , ECs must maintain a complete record of all research proposals received and reviewed. Approved project documentation and any relevant correspondence must also be retained. Records must be maintained in accordance with the requirements of relevant Commonwealth and state or territory legislation and guidelines. See G-NatlStmt for detailed records requirements.

For more details on the governance and responsibilities of Australian institutional ECs, see the G-NatlStmt .

According to the G-NatlStmt , the institutional ethics committee (EC) (Human Research Ethics Committee (HREC) in Australia) is responsible for protecting the interests of research participants and for promoting good research by ensuring adherence to the values of research merit and integrity, beneficence, justice, and respect for persons throughout the conduct of the research project. The EC must review the recruitment and consent processes, weigh the benefits and risks of the research, and consider the impact of the research on certain groups of participants deemed to merit special consideration. Additionally, ECs may conduct both scientific and ethics review or may delegate scientific review to a sub-committee.

Pursuant to the G-NatlStmt , the establishment and maintenance of ethics review processes and processes for assessing the risk level of the research are part of an institution’s overall governance responsibility. In addition to ethics approval, research must also be authorized by each institution with responsibility for oversight of the research before it can proceed. See the Oversight of Ethics Committees , Submission Process , Submission Content , Timeline of Review , and Initiation, Agreements & Registration sections for more information on research governance requirements.

Role in Clinical Trial Approval Process

According to the G-CTHandbook , the G-TrialsSOP , and AUS-47 , ECs are responsible for reviewing and approving protocols involving unapproved therapeutic goods under one (1) of two (2) regulatory schemes—the Clinical Trial Notification (CTN) scheme or the Clinical Trial Approval (CTA) scheme—prior to the sponsor initiating a trial. According to AUS-40 , all public and private health organizations must also undertake a site-specific assessment (SSA) of each research project. This allows the institution to consider whether the project is suitable for the site, and whether it has the capacity to conduct the research at that site. Per the G-TrialsSOP , the SSA and ethics review may occur in parallel. However, EC approval must be obtained and submitted to the research governance officer (RGO) of each participating institution before institutional authorization is granted.

The G-CTHandbook states that a CTN scheme is a notification scheme under which the Therapeutic Goods Administration (TGA) does not review or evaluate any data relating to the clinical trial. The EC is responsible for assessing the scientific validity of the trial design, the balance of risk versus harm of the therapeutic good(s), and the overall ethical acceptability of the trial. Per AUS-47 , EC and institutional review and approval/authorization may be conducted in parallel to the CTN form submission to the TGA; however, it is the sponsor’s responsibility to ensure that all relevant approvals and authorizations are in place before commencement of the trial.

Under the CTA scheme, as delineated in the G-CTHandbook , the TGA reviews relevant, but limited, scientific data, while the EC is responsible for considering the scientific and ethical issues of the proposed trial protocol.

Per the G-CTHandbook , the sponsor determines whether to conduct a clinical trial under the CTN or CTA scheme. Consulting the EC responsible for protocol approval may assist the sponsor in making the decision. One of the determining factors for an EC is whether the committee has access to appropriate scientific and technical expertise in order to assess the safety of the product. If an EC feels that it requires additional expertise to review a CTN, it may seek advice from external authorities or it may seek to collaborate with another EC that has the required expertise. An EC may also determine that it does not have access to the appropriate scientific and technical expertise to review the proposed trial under the CTN scheme and recommend review under the CTA scheme.

AUS-14 states that prior to approving a clinical trial, the EC must be satisfied that the trial protocol complies with the following requirements:

• Declaration of Helsinki ( AUS-52 )
• AU-ICH-GCPs
• TGA requirements, including the G-CTHandbook and the G-SafetyDataMgt
• Any relevant Australian Government and/or state/territory laws

The G-CTHandbook and the TGR state that during its review, the EC also needs to be aware of relevant state and territory laws pertaining to the supply of therapeutic goods or other clinical trial-related matters. The G-CTHandbook further indicates that ECs have a high level of independence and are responsible for establishing their own processes for reviewing research proposals. According to the G-CTHandbook and the AU-ICH-GCPs , if requirements specified in the G-NatlStmt appear to differ from those specified in the AU-ICH-GCPs , the TGA recommends compliance with the G-NatlStmt .

As stated in AUS-20 , ECs also consider the protection of privacy for humans participating in research and their data. ECs do this by considering whether the research proposal conforms to relevant legislation, principles, and guidelines, including federal and/or state/territory legislation as well as the G-PrivacyAct95 and G-PrivacyAct95A guidelines. See the Personal Data Protection section for more information.

Per the G-NatlStmt , an EC may approve, request modification of, reject, or withdraw approval of a research proposal. The EC must clearly communicate its decision to the researcher(s):

• Where a proposal is approved or rejected, or where approval is withdrawn, communication must be in writing (which may include electronic formats) and should include an explicit statement that the proposal meets or did not meet the requirements of the G-NatlStmt . If rejecting or withdrawing approval of a research proposal, the EC should provide the rationale for its decision, including citing the provisions of the G-NatlStmt or relevant institutional policy that underpins its decision, if relevant.
• Where modifications are requested, communication may be written or, where appropriate, informal; however, a record should be kept of any informal communication, and guidance should be clearly communicated regarding to whom the researcher’s response should be directed .

According to the G-NatlStmt , varying processes may be used for the review and approval of project extensions, amendments to an approved project, progress reports, and renewal of project approval. Appropriate processes depend on the nature of the original project and any proposed changes, but any process authorized by an institution for these purposes must prioritize the safety and well-being of participants, researchers, and/or the community.

Pursuant to the G-CTHandbook and the TGR , when the EC approves a trial protocol, it takes responsibility for monitoring the progress and conduct of the trial. However, the G-NatlStmt indicates that each institution has ultimate responsibility for ensuring, via its research governance arrangements, that all its authorized research is monitored. Monitoring arrangements should be commensurate with the risk, size, and complexity of the research. Monitoring responsibilities that are performed by the institution’s EC should be based on the EC’s review of the project. However, where research that will take place at multiple sites has been reviewed by only one (1) EC, the ECs of the other institutions participating in the project do not have knowledge of the project. In such cases, only the reviewing EC can take on those elements of monitoring a research project that are commonly performed by ECs.

Per the G-NatlStmt , if the EC or institution has reason to believe that continuance of a research project would compromise participants' welfare, or if the conditions of ethics approval for the project are not being adhered to, it should immediately seek to establish whether ethical approval for the project should be suspended or withdrawn. If an institution or EC considers that suspension of research is necessary, the instruction to stop should come from the management of the institution. If ethics approval for a research project is suspended, the researcher, the institution(s), and, where possible, the participants should be informed of the suspension.

As indicated in the G-NatlStmt , ECs may require researchers to amend research procedures to protect participants. If an EC determines that such changes cannot achieve that end, the EC may decline to grant an extension to project approval or decide to withdraw approval for the research. Where ethics approval for a research project is withdrawn:

• The researcher, the institution(s), and, where possible, the participants should be informed of the withdrawal
• Continuation of the research project is subject to re-application and re-approval by the EC

See the G-NatlStmt for more details on institutional and EC responsibilities regarding research monitoring.

External Ethics Approval and the National Mutual Acceptance Scheme

The G-NatlStmt encourages the minimization of unnecessary duplication of ethics review, including for research conducted in multiple Australian jurisdictions or across international boundaries. Institutions may accept an ethics review conducted by an entity external to the institution (including overseas review bodies) and should determine their criteria for this acceptance.

Per the G-NatlStmt , researchers who wish to submit evidence of ethics approval by an external EC in support of single ethics review should be aware of existing national or international programs, protocols, policies, standards, and guidance that may be relevant to the institutional decision to accept the review. To facilitate the efficient ethics review of research, researchers must inform any EC of:

• All sites at which the research will be conducted
• Any information on local site circumstances that is relevant to the ethics review
• Any other body that will be considering ethical issues related to the research
• Any previous decisions to approve, re-consider, or deny approval of the research by another review body in Australia or elsewhere

See the G-NatlStmt for more information on external ethics approval.

As described in AUS-21 and AUS-41 , the National Mutual Acceptance (NMA) scheme further supports the acceptance of a single scientific and ethical review of multicenter research conducted in publicly funded health services. All state and territory-certified public health organizations in Australia are part of the NMA scheme.

Per AUS-68 , in order for ethics reviews of human research to be accepted under NMA, the EC conducting the review must be certified under the National Health and Medical Research Council (NHMRC) National Certification Scheme of Institutional Processes Related to the Ethical Review of Multi-centre Research (National Certification Scheme), and also be a “Certified Reviewing HREC” under the NMA scheme.

For more information on submissions to ECs under the NMA scheme and the National Certification Scheme, see the Submission Process and Oversight of Ethics Committees sections .

Exemption from Ethics Review

As stated in the G-NatlStmt , some research may be eligible for exemption from ethics review. Where appropriate, exemption is granted, or not, by the institution responsible for the research. Where there is no institution providing oversight of the research, researchers should request a grant of exemption from an EC. Research that may be eligible for exemption from ethics review includes research that carries a lower risk to participants or the community, and satisfies one (1) or more of the following conditions:

• The research involves the use of collections of information or data from which all personal identifiers have been removed prior to being received by the researchers, and where researchers explicitly agree: (i) not to attempt to re-identify those with whom the information or data is associated; (ii) to take all reasonable steps to prevent re-identification of the information or data for unauthorized purposes or access to the information or data by those who are not authorized; and (iii) that any sharing of any research data during or after the project will not create any additional risks of re-identification of the information or data
• The research is restricted to surveys and observation of public behavior using information that was or will be collected and recorded without personal identifiers and is highly unlikely to cause distress to anyone associated with the information or the outcomes of the research
• Is conducted as part of an educational training program in which the research activity is for training purposes only and where any outcomes or documentation are for program use only
• The research uses only information that is publicly available through a mechanism set out by legislation or regulation and that is protected by law, such as mandatory reporting information, information obtained from registries of births and deaths, coroner’s investigations, or reports of the Australian Bureau of Statistics

The G-NatlStmt indicates that institutions or other granting bodies must keep a record of any decision to grant exemption from ethics review. See the G-NatlStmt for more information on ethics review exemption.

The G-NatlStmt indicates that when establishing an ethics committee (EC) (Human Research Ethics Committee (HREC) in Australia), an institution must set out and publicize its terms of reference, including its schedule of fees charged, if any, for ethics review. The institution is responsible for ensuring that its EC operates in accordance with the G-NatlStmt , which includes being satisfied that any fees charged for EC review do not discourage research that the institution has an obligation to support.

As per the TGAct , the G-TrialsSOP , and the G-CTHandbook , the National Health and Medical Research Council (NHMRC) is responsible for receiving applications from ethics committees (ECs) (Human Research Ethics Committees (HRECs) in Australia) to be registered. The NHMRC was established by the NHMRCAct . Per the NHMRCAct , the NHMRC’s activities are designed to raise the standard of individual and public health throughout Australia; to foster the development of consistent health standards between the various states and territories; to foster medical and public health research and training throughout Australia; and to foster consideration of ethical issues relating to health.

Research Governance

Pursuant to the G-NatlStmt , institutions may fulfill their research governance responsibilities by establishing and overseeing different levels of ethics review. One (1) or more institutions can individually or jointly establish an EC or any other ethics review body. Institutions that establish an EC are responsible for adequately resourcing and maintaining it, including providing sufficient administrative support.

According to the G-NatlStmt , institutions should ensure that all ethics review processes and the criteria that are used for determining the appropriate process are clear, transparent, and published to enable researchers to submit their research proposals efficiently.

The G-NatlStmt further states that institutions should clearly publicize their policy for access to their EC or other ethics review processes by researchers who are not affiliated with the institution. Additionally, institutions should regularly assess all their ethics review processes, including the criteria for allocating research to different levels of review, to ensure that those processes continue to enable the institution to meet its responsibilities under the G-NatlStmt . Where possible this assessment should be informed by the documented experience of research participants and/or by involving participants or the wider community in the assessment.

Furthermore, as delineated in the G-NatlStmt , institutions should have in place an auditing process to confirm that research is being reviewed at the levels of review that their criteria require and research is being exempted from review only in accordance with the criteria set out in the G-NatlStmt . See the Scope of Review section for more information on exemption criteria.

Registration, Auditing, and Accreditation

According to the G-NatlStmt , institutions that have responsibility for oversight of research and maintain ECs must register their ECs with the NHMRC. ECs that are not associated with institutions must register themselves with the NHMRC.

Per AUS-20 , registration means that the EC has notified the NHMRC of its existence and declared that it meets the requirements of the G-NatlStmt . In order to review and monitor clinical trials of unregistered therapeutic goods, an EC must be notified to the NHMRC, and constituted and operating in accordance with the G-NatlStmt . Forms for registering an EC, notifying the NHMRC of changes to the EC, or terminating an EC’s registration are available at AUS-20 .

As per the G-NatlStmt , an institution and its EC must report annually, or upon request, to the NHMRC. The NHMRC, through the Australian Health Ethics Committee (AHEC), will review the activities of ECs to ensure conformance with the G-NatlStmt . Reportable information may include:

• Membership/membership changes
• Number of meetings
• Confirmation of participation in meetings by members in minimum membership categories
• The number of research proposals presented, the number approved, the number requiring modification prior to approval, and the number rejected
• Monitoring procedures that are in place and any problems encountered with monitoring of projects
• Complaints procedures and number of complaints handled
• Any other relevant policies, procedures, or processes as determined by the NHMRC

The G-NatlStmt further indicates that failure to comply with the requirements of the G-NatlStmt may result in the EC being removed from the list of ECs registered with NHMRC. See AUS-20 for more information and the list of registered ECs.

National Certification Scheme

According to AUS-21 , the NHMRC developed the National Certification Scheme of Institutional Processes Related to the Ethical Review of Multi-centre Research (National Certification Scheme) to enable the single ethics and scientific review of human research occurring at multiple institutions in Australia. Under this scheme, certified institutions can have their ethics review accepted by other institutions participating in the research project. As part of the National Certification Scheme, certified institutions and their ECs are required to report to the NHMRC on their multicenter research activities.

As per AUS-21 , the NHMRC assesses each institution’s interest in certification on a case-by-case basis. Certification respects institutional decisions about research governance matters, including whether research should be conducted at a given site. Before commencing steps to apply for certification, institutions should contact [email protected] .

For more information on the National Certification Scheme and the NHMRC’s continuous certification process, see AUS-21 .

As stated in AUS-68 , EC certification under the National Certification Scheme is required in order for ethics reviews of human research to be accepted under the National Mutual Acceptance (NMA) scheme. The NMA scheme facilitates single scientific and ethical review of clinical trials conducted in participating jurisdiction’s public health organizations. See the Scope of Review section for more information on NMA.

In accordance with the G-CTHandbook , the G-TrialsSOP , and AUS-47 , Australia requires the sponsor to obtain clinical trial authorization from the Therapeutic Goods Administration (TGA) for the supply of unapproved therapeutic goods for clinical trials for experimental purposes in humans. The sponsor can apply under two (2) regulatory schemes—the Clinical Trial Notification (CTN) scheme and the Clinical Trial Approval (CTA) scheme.

Under either regulatory scheme, per the TGR , the G-CTHandbook , the G-TrialsSOP , and AUS-47 , an ethics committee (EC) (Human Research Ethics Committee (HREC) in Australia) must approve the research protocol. The G-NatlStmt further specifies that any research that involves greater than low risk must be reviewed by an EC. AUS-47 indicates that the review and approval/authorization by an EC and institution may be conducted in parallel to the CTN form submission to the TGA, but it is the sponsor’s responsibility to ensure that all relevant approvals and authorizations are in place before commencement of the trial.

According to AUS-40 , all public and private health organizations must also undertake a site-specific assessment (SSA) of each research project. This allows the institution to consider whether the project is suitable for the site, and whether it has the capacity to conduct the research at that site. Per the G-TrialsSOP , the SSA and ethics review may occur in parallel. However, EC approval must be obtained and submitted to the research governance officer (RGO) of each participating institution before institutional authorization is granted. While there is no submission language requirement stated in the requirements, the official language of Australia is English.

Regulatory Submission

Per AUS-17 , sponsors may request pre-submission meetings with the TGA. See AUS-17 for the applicable forms.

According to AUS-47 and AUS-30 , CTN forms are submitted online through the TGA Business Services (TBS) webpage ( AUS-36 ). The sponsor must have or obtain a TGA Client Identification Number.

As per AUS-49 , to submit the online CTN form successfully through AUS-36 , the sponsor must accept a declaration to assume responsibility for the trial. After accepting the declaration, a webpage will advise the sponsor that the CTN submission has been successful. According to AUS-47 , the TGA does not send an acknowledgement letter by email since this information is available for viewing and printing via the online portal. The TGA advises clinical trial sponsors to obtain and save a printout of notification at each stage of the submission process.

AUS-49 indicates that the sponsor may delegate duties and correspondence with the TGA to an authorized agent, which is able to create and submit a CTN on behalf of a sponsor. If an agent has submitted a CTN on the sponsor’s behalf, the sponsor will not have access to view or vary the CTN. Access is only granted to the agent.

See AUS-30 and AUS-49 for additional information on using and submitting the online form.

According to AUS-47 , the sponsor must complete and submit two (2) forms ( AUS-56 and AUS-57 ) to the TGA via email at [email protected] . Supporting data for the CTA application should be provided in electronic format, preferably on USB or CD-ROM via post. The trial commencement notification form ( AUS-57 ) must be sent to the TGA within 28 days of commencing supply of the unapproved therapeutic goods.

Per AUS-47 , those with queries regarding the CTA scheme are encouraged to contact the TGA directly at [email protected] .

Ethics Review Submission

AUS-46 indicates that the National Health and Medical Research Council (NHMRC) developed the Human Research Ethics Application (HREA) form ( AUS-9 ) as a concise application to facilitate timely and efficient ethics review for research involving humans. The HREA assists researchers in considering the ethical principles of the G-NatlStmt in relation to their research and is accepted by institutions that participate in the National Mutual Acceptance (NMA) scheme, which facilitates single ethics review by multiple public health organizations for most human research.

According to the G-CTHandbook , trial sponsors and researchers should use the HREA unless advised otherwise. AUS-19 contains resources for using the HREA.

Per AUS-46 , research proposals should be submitted to ECs associated with public health institutions in New South Wales, Queensland, South Australia, Australian Capital Territory, and Victoria, as well as Mater Research, via the Research GEMS system ( AUS-55 ), the Ethical Review Manager (ERM) website ( AUS-8 ), and/or the Research Ethics and Governance Information System (REGIS) ( AUS-10 ), depending on which jurisdictions are involved. For research in the Northern Territory, Tasmania, or Western Australia, the EC should be contacted for their local submission requirements.

The G-CTHandbook further states that ECs have a high level of independence and are responsible for establishing their own processes for receiving research proposals.

According to the G-NatlStmt , institutions should publish (such as on their website) clear policies and procedures for institutional authorization of research. As noted in the G-CTHandbook , individual jurisdictions have specific requirements as a part of their SSA and authorization processes. South Australia sites use the online SSA form found in the Research GEMS system ( AUS-55 ), while the ERM website ( AUS-8 ) is used for SSA form submission for Mater Research, Queensland, and Victoria. New South Wales and the Australian Capital Territory use REGIS ( AUS-10 ) for site governance applications.

Regulatory Authority Requirements

Clinical Trial Notification (CTN) Scheme

As delineated in AUS-49 , the following information must be submitted to the Therapeutic Goods Administration (TGA) through the online form on the TGA Business Services (TBS) webpage ( AUS-36 ):

• Sponsor name and address
• Sponsor declaration
• Notification fee (See Regulatory Fees section )
• Organization-nominated contact’s name, phone number, and email
• An optional alternative contact, which may be chosen from the contacts for the agent or sponsor organization submitting the CTN
• Protocol number
• Expected trial start and completion dates
• Potential use of restricted goods
• Study title and description
• “This Trial” check boxes indicating whether the trial involves the use of a medicine, a medical device, and/or a biological
• Whether the trial is a first in human trial
• Whether the trial, in part or as a whole, has been halted/stopped/withdrawn or rejected in another country due to safety concerns
• Total number of trial participants
• Therapeutic area
• Investigational product (IP) details
• Whether it is a multi-center trial
• Whether the trial is being conducted in other countries
• Preceding trial details
• Trial site details

See AUS-49 for detailed descriptions of each required item.

Clinical Trial Approval (CTA) Scheme

AUS-47 states that the CTA scheme application consists of two (2) forms – Part 1: the application ( AUS-56 ), and Part 2: Notification of the conduct of a trial under the CTA scheme ( AUS-57 ).

The Part 1 CTA application form ( AUS-56 ) requires general information (sponsor name, data details, and sponsor declaration) and details on the medicine (active ingredient)/biological be submitted to the TGA.

The Part 2 CTA application form ( AUS-57 ) requires trial sponsor information (name and client ID code), the IP or biological, and the notification type, as well as trial and trial site details (title of study and trial type). The form also requires signed certifications from the sponsor, the principal investigator (PI), the ethics committee (EC) (Human Research Ethics Committee (HREC) in Australia), and the authority approving the conduct of the trial.

Ethics Committee Requirements

Per the G-CTHandbook , the EC and the institution are responsible for establishing what information should be provided in support of an application. The EC should request any additional information that it believes is necessary to undertake review of the proposed research. Unless advised otherwise, trial sponsors and researchers should use the Human Research Ethics Application (HREA) for submitting proposals for research involving humans to ECs.

AUS-46 indicates that the HREA assists researchers in considering the ethical principles of the G-NatlStmt in relation to their research. The G-NatlStmt requires that those who conduct and approve human research to consider:

• How the research question/theme is identified or developed
• The alignment between the research aims and methods
• How the researchers and the participants will engage with one another
• How the research data or information are to be collected, stored, and used
• How the results or outcomes will be communicated
• What will happen to the data and information after the project is completed

For more information on the HREA, see the Submission Process section.

The G-NatlStmt further specifies that in an application for review of their research, researchers should determine and state in plain language:

The research question or questions that the project is intended to explore

The potential benefit of exploring the question or questions including to whom that potential benefit is likely to flow, and whether that benefit is a contribution to knowledge or understanding, improved social or individual wellbeing, or the skill and expertise of researchers

The basis for that potential benefit as described in either relevant literature or a review of prior research unless, due to the novelty of the question, there is scarce literature or prior research

How the design and methods of the project will enable adequate exploration of the research questions and achieve the aims of the research

How the design of the project will maintain respect for the participants

Where relevant, that the research meets the requirements of any relevant regulations or guidelines authorized by law (such as those related to privacy and reporting requirements for disclosure of child abuse)

Whether or not the project has been reviewed by a formally constituted academic, scientific, or professional review process, and, if so, the outcome of that review

According to the G-NatlStmt , institutions should publish (such as on their website) clear policies and procedures for institutional authorization of research. See the Research GEMS system ( AUS-55 ), the Ethical Review Manager (ERM) ( AUS-8 ), and the Research Ethics and Governance Information System (REGIS) ( AUS-10 ) websites for public health organization site-specific assessment (SSA) forms, which may differ between institutions and states or territories.

Clinical Protocol

The G-TrialsSOP indicates that where the investigator is responsible for the protocol development, the investigator must ensure the protocol follows the outline in the AU-ICH-GCPs . Specific content of a protocol will vary depending on the research area, the level of risk to participants, the phase of the research and study design, and whether a medicinal product or a device or a therapeutic intervention is being researched. If satellite sites for a teletrial are involved in the study, no specific additional wording is required in the protocol, as relevant considerations will be addressed in other study-specific documents which may be annexed to the protocol.

The AU-ICH-GCPs provides the following outline of the protocol:

• General information (protocol title, identifying number, and date; contact information for the sponsor, medical expert, investigator(s), trial site(s), qualified physician(s), and laboratory and/or institutions involved in the study)
• Background information
• Objectives and purpose
• Trial design
• Selection, withdrawal, and treatment of participants
• Assessment of efficacy
• Assessment of safety
• A description of the statistical methods to be used in the trial
• Direct access to source data and documents
• Quality control and quality assurance
• Ethical considerations
• Data handling and recordkeeping
• Financing and insurance
• Publication policy

In accordance with the G-CTHandbook , the G-TrialsSOP , and AUS-47 , the Therapeutic Goods Administration (TGA) is responsible for authorizing the supply of unapproved therapeutic goods for clinical trials under two (2) regulatory schemes—the Clinical Trial Notification (CTN) scheme and the Clinical Trial Approval (CTA) scheme. According to the TGR , the G-CTHandbook , the G-TrialsSOP , and AUS-47 , under either regulatory scheme, an ethics committee (EC) (Human Research Ethics Committee (HREC) in Australia) must approve research protocols. The G-NatlStmt further specifies that any research that involves greater than low risk must be reviewed by an EC. AUS-47 indicates that the review and approval/authorization by an EC and institution may be conducted in parallel to the CTN form submission to the TGA, but it is the sponsor’s responsibility to ensure that all relevant approvals and authorizations are in place before commencement of the trial.

According to AUS-40 , all public and private health organizations must also undertake a site-specific assessment (SSA) of each research project. Per the G-TrialsSOP , the SSA and ethics review may occur in parallel.

Regulatory Authority Approval

AUS-47 states that the TGA’s target time to process online CTNs is five (5) to seven (7) working days, but the agency tries to process the notification as soon as possible. This timeframe does not include the time taken for TGA finance to match the payment (if required) to a submission. For information on how to check the status of a CTN, see AUS-49 .

No timeline information is available for applications under the CTA scheme. Per AUS-47 , parties that are considering submitting a CTA application are strongly encouraged to contact the TGA at [email protected] for advice regarding the application process.

Ethics Committee Approval

The EC review and approval process timeline varies by institution. However, according to the G-NatlStmt , the institutional EC must implement standard operating procedures that promote good ethics review, including timely consideration of applications.

The G-GovHndbk indicates that ethical review and site assessment, both components of research governance, are two (2) distinct processes relating to the ethical approval and institutional authorization of research involving humans. However, because evidence of EC approval is a component of the site assessment process, institutional authorization of a research project cannot be given until EC approval has been provided. The G-TrialsSOP further specifies that EC approval must be obtained and submitted to the research governance officer (RGO) of each participating institution before institutional authorization is granted.

While some parts of the research governance review must occur after the EC review, the G-GovHndbk recommends that as part of the national approach to single ethical review, institutions establish processes to facilitate parallel review. Project documentation processes related to site assessment may be considered as falling into these categories:

• That which can be assessed independent of ethical review, such as evidence of research qualifications, supporting department approval forms, contracts, budgets, and insurance and indemnity documents
• That which is subject to ethical review, but can be submitted prior to or in parallel with ethical review to enable independent assessment of other documentation, such as initial project application documents
• That which can only be assessed subsequent to ethical approval, such as approved project application documents, fully signed regulatory documents, and a certificate of ethical approval

See the G-GovHndbk for additional National Health and Medical Research Council (NHMRC) guidance on best practices in the governance of multicenter human research as part of the national approach to single ethical review.

The NHMRC also developed the GPP-SiteAssess to help institutions streamline the research governance process and shorten clinical trial start-up times. See the GPP-SiteAssess for more information.

In accordance with the G-TrialsSOP , the G-CTHandbook , and AUS-47 , clinical trials involving unapproved therapeutic goods can only commence under the Clinical Trial Notification (CTN) scheme or the Clinical Trial Approval (CTA) scheme. According to the G-GovHndbk and the G-TrialsSOP , under either scheme, both institutional ethics committee (EC) (Human Research Ethics Committees (HRECs) in Australia) approval and research governance authorization are required before a research project can commence at a site.

Per the G-GovHndbk , research must be governed by the institution at all stages of a project. Ethical review and site assessment, both components of research governance, are two (2) distinct processes relating to the ethical approval and institutional authorization of research involving humans. According to AUS-40 , all public and private health organizations must undertake a site-specific assessment (SSA) of each research project. This allows the institution to consider whether the project is suitable for the site, and whether it has the capacity to conduct the research at that site. Pursuant to the G-NatlStmt , authorization of research by the institution should consider, but not re-review, any issues raised during the ethics review of the research proposal, and each institution should have a process or processes for assessing the risk level of the research. These processes may involve seeking advice from relevant clinical or administrative staff, members of an EC, or a full meeting of the EC. All research should be developed, reviewed, authorized, conducted, and monitored in accordance with a research governance framework as described in an institution’s policy. For more information on institutional responsibilities, see the Site/Investigator Selection section .

The G-TrialsSOP states that in the case of a teletrial, the principal investigator (PI) must ensure that a robust site assessment is undertaken that fully quantifies the capabilities of each satellite site to inform the extent to which trial related activities can be delegated to the site. This may include a pre-commencement assessment before a specific trial is proposed so that the process of trial start up is expedited when a suitable trial is identified.

Per the G-TrialsSOP , prior to a study’s commencement, the PI must:

• Submit the primary site's Clinical Trial Research Agreement (CTRA), EC approval, the SSA form, evidence of any relevant good clinical practice (GCP) training, and any other required documentation to the institution’s research governance officer (RGO)
• Ensure all documentation and correspondence pertaining to the submission and approval processes is filed in the study master file (SMF) (see Appendix 8 of the G-TrialsSOP )
• Ensure each satellite site completes and submits to their RGO a clinical trial sub-contract and a SSA form
• Await site specific RGO authorization before any study related activity can occur at that site
• Ensure the satellite site files all documentation in the satellite site study file (SSSF)

The G-TrialsSOP further states that prior to the initiation of a study, the investigator must also mutually agree with the sponsor on a scheduled date, time, and location for a study initiation visit at the participating site to ensure the site is prepared to commence the study. In the case of a teletrial, this may be at the primary site only, or could include (remotely) the satellite site(s) as determined by the study complexity by the sponsor/PI.

See the G-TrialsSOP for more information on site initiation requirements for primary and satellite sites.

The G-GovHndbk further indicates that in the national approach to single ethical review, site assessment and project authorization are the responsibility of each institution participating in a multicenter human research project while ethical review is provided by a single EC using certified ethical review processes. Each institution collaborating in a multicenter project utilizing the outcome of a single ethical review must individually authorize the commencement of research at their institution. To avoid unnecessary delays in research commencing at all collaborating centers and sites, each institution should consider relevant local matters prior to or in parallel with ethical review.

Clinical Trial Agreement

As delineated in the AU-ICH-GCPs , the sponsor must sign an agreement between all involved parties, including investigators, institutions, contract research organizations, and others for documentation purposes. Further, the sponsor should obtain the investigator’s/institution's agreement:

• To conduct the trial in compliance with good clinical practice, with the applicable regulatory requirement(s), and with the protocol agreed to by the sponsor and given approval/favorable opinion by the EC
• To comply with procedures for data recording and reporting
• To permit monitoring, auditing, and inspection
• To retain the trial-related essential documents until the sponsor informs the investigator/institution these documents are no longer needed

The sponsor and the investigator/institution should sign the protocol, or an alternative document, to confirm this agreement.

For the purposes of the G-TrialsSOP , the CTRA for the primary site and the sub-contract for each satellite site constitute part of a research governance application, which is submitted to the RGO. The CTRA covers matters such as confidentiality, intellectual property, ownership of data, insurance, and indemnity. The Medicines Australia CTRA (see AUS-38 ) is the recommended standard form.

Clinical Trial Registration

The G-NatlStmt requires that clinical trials be registered on a publicly accessible register complying with international standards before recruitment of the first participant. For information on these standards, see the World Health Organization (WHO)’s International Clinical Trials Registry Platform (ICTRP) ( AUS-67 ). Per AUS-15 , the Australian and New Zealand Clinical Trials Registry (ANZCTR) ( AUS-12 ) recommends applying for registration at the same time as ethics submission.

Safety Reporting Definitions

According to the G-SftyRpt , the following definitions provide a basis for a common understanding of Australia’s safety reporting requirements:

• Adverse Event (AE) – Any untoward medical occurrence in a patient or clinical trial participant administered a medicinal product and that does not necessarily have to have a causal relationship with this treatment
• Adverse Reaction (AR) – Any untoward and unintended response to an investigational medicinal product related to any dose administered
• Unexpected Adverse Reaction (UAR) – An adverse reaction, the nature or severity of which is not consistent with the applicable product information (e.g., investigator's brochure (IB) for an unapproved investigational medicinal product)
• Serious Adverse Event (SAE) or Serious Adverse Reaction (SAR) – Any adverse event/adverse reaction that results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in persistent or significant disability or incapacity, or is a congenital anomaly or birth defect
• Suspected Unexpected Serious Adverse Reaction (SUSAR) – An adverse reaction that is both serious and unexpected
• Significant Safety Issue (SSI) – A safety issue that could adversely affect the safety of participants or materially impact the continued ethical acceptability or conduct of the trial
• Urgent Safety Measure (USM) – A measure required to be taken in order to eliminate an immediate hazard to a participant’s health or safety (Note: This type of SSI can be instigated by either the investigator or sponsor and can be implemented before seeking approval from ethics committees ( ECs) or institutions)

Safety Reporting Requirements

Investigator Responsibilities

As specified in the G-SftyRpt , the investigator is responsible for recording and assessing all AEs that occur at the site. The investigator is also required to inform the sponsor of all SAEs, and all USMs instigated by the site, within 24 hours of becoming aware of the event. All safety critical events must be reported to the sponsor, and for reported deaths, the investigator should supply the sponsor with any additional requested information. Further, the investigator must report to the institution all SSIs and SUSARs arising from the local site within 72 hours of becoming aware of the event.

However, the G-TrialsSOP states that the investigator must also report any SUSARs to the sponsor within 24 hours of becoming aware of the event, and USMs instigated by the investigator or site must be reported to the sponsor within 72 hours. Furthermore, the investigator must report all other significant issues to the sponsor within 15 days of instigating or becoming aware of the event. The investigator must notify the sponsor promptly regarding any changes significantly affecting the conduct of the trial, and/or increasing the risk to participants. The investigator must also be available to meet with the sponsor to discuss study progress, issues, and safety.

The G-TrialsSOP requires that within 72 hours of instigating or becoming aware of the event, the investigator must notify the institution of:

• SUSARs arising from the local site
• Any information received from the sponsor that may be new and have an impact on the continued ethical acceptability of the trial or may indicate the need for amendments to the trial protocol, including monitoring of safety

The G-TrialsSOP indicates that for satellite site(s) in teletrials, staff must report safety issues directly to the sponsor as per the timelines specified in the clinical trial protocol and the safety monitoring plan or similar document, in the same way as the primary site. Certified copies of the relevant safety reports/documentation generated at the satellite site must be sent to the primary site for filing in a study master file.

According to the G-TrialsSOP , the principal investigator (PI) must ensure that study staff, including those at teletrial satellite sites, are trained in the protocol, investigator’s brochure (IB), study procedures, and AE/SAE reporting. The PI must also ensure that a system for safety reporting duties is in place for all study staff. For more information on investigator responsibilities related to standard operating procedures (SOPs), see the G-TrialsSOP .

Sponsor Responsibilities

As delineated in the G-SafetyDataMgt , the G-SftyRpt , and the G-CTHandbook , the sponsor is required to expedite reporting of SUSARs to the Therapeutic Goods Administration (TGA) .

The G-SafetyDataMgt indicates that other situations requiring expedited reporting may include information that might materially influence the benefit-risk assessment of an investigational product, or that would be sufficient to consider changes in the administration or conduct of a clinical trial.

According to the G-SftyRpt and the G-TrialsSOP , expedited reporting requires the sponsor to file reports to the TGA in the following specified timelines:

• For an Australian SUSAR that is fatal or life-threatening, immediately, but no later than seven (7) calendar days, with any follow-up information within eight (8) calendar days
• For all other Australian SUSARs, no later than 15 calendar days after becoming aware of the case

The G-SftyRpt and the G-TrialsSOP further indicate that the TGA, the EC, and investigators must also be notified of all SSIs that adversely affect the safety of participants, or materially impact the continued ethical acceptability or conduct of the trial. SSIs that meet the definition of a USM should be reported within 72 hours, and all other SSIs should be reported within 15 calendar days of the sponsor being made aware of the issue. It is strongly recommended that the sponsor contact the TGA within 24 hours of a USM being taken, and if initial contact is by telephone, it should be followed up with a written notification provided by e-mail within 72 hours. See AUS-53 for additional information on SSIs and USMs.

Per the G-SftyRpt , submitting individual reports of AEs, SAEs, and SUSARs to ECs, institutions, and investigators are no longer required. However, according to the G-TrialsSOP , the sponsor must provide the EC with an updated IB at least annually that supports trial oversight, depicts a clear picture of the evolving trial safety profile, and provides evidence that the sponsor is conducting its safety monitoring appropriately.

The G-CTHandbook and the G-SftyRpt further require the sponsor to maintain records of all other single case AEs and submit them to the TGA upon request. The G-CTHandbook indicates that the TGA does not require sponsors to submit individual SUSARs from outside Australia. Sponsors should continually monitor the safety of their clinical program and advise the TGA of any SSIs that arise from their analysis of overseas reports, or of any action that has been taken by another country’s regulatory agency. Investigators and ECs should also be informed of this information, and sponsors must be able to provide the TGA with the clinical details of any individual overseas AE reports if requested.

According to the G-TrialsSOP , the sponsor’s plans for safety data monitoring should be documented in a safety monitoring plan or similar document and be given to the PI prior to commencement of the clinical trial. The plan must be continually reviewed and updated during the trial, as real-time assessments of safety data are performed, and outcomes are made available.

Other Safety Reports

The G-SftyRpt delineates that the sponsor must provide the EC with an annual safety report including a clear summary of the evolving trial safety profile. The annual safety report should generally include:

• A brief description and analysis of new and relevant findings
• For investigational products (IPs) not on the Australian Register of Therapeutic Goods (ARTG) ( AUS-22 ), a brief analysis of the safety profile of the IP and its implications for participants
• A brief discussion of the implications of the safety data to the trial’s risk-benefit ratio
• A description of any measures taken or proposed to minimize risks

A Development Safety Update Report (DSUR) or other similar document may also serve as the annual safety report. See the G-SftyRpt for more information.

Form Completion & Delivery Requirements

As per the G-CTHandbook , all SUSARs from Australian sites must be reported to the TGA using one (1) of three (3) formats:

• The Electronic Data Interchange (EDI) functionality, which allows sponsors to submit AE reports directly from their system to the TGA (more information can be found at AUS-26 )
• The online reporting form, which can be accessed from AUS-51
• The CIOMS Form I ( AUS-4 ) or the TGA’s Blue Card Adverse Reaction Reporting Form ( AUS-3 )

Per AUS-3 , the Blue Card form may be emailed to [email protected] or mailed to Pharmacovigilance and Special Access Branch, Reply Paid 100, Woden ACT 2606. More information about reporting to the TGA may be found at AUS-7 .

See AUS-37 for the SSI/USM reporting form.

Interim and Annual Progress Reports

As per the AU-ICH-GCPs , the G-NatlStmt , and the G-TrialsSOP , the investigator(s) is responsible for submitting progress reports to the ethics committee (EC) (known as Human Research Ethics Committee in Australia) annually, or more frequently if requested. The AU-ICH-GCPs and the G-TrialsSOP state that if there are significant changes in trial conduct or safety, the investigator should submit a written report to the sponsor, the EC, and where applicable, the institution. The G-NatlStmt indicates that at regular periods (reflecting the degree of risk, and at least annually), researchers should provide reports to the relevant EC(s) and institution(s), including information on:

• Progress to date
• The security of project-related data and information
• Compliance with the approved proposal
• Compliance with any conditions of approval

According to the G-NatlStmt , progress report forms should be designed to collect information that can provide meaningful assistance to reviewers in determining whether continuation of ethics approval is warranted. See the G-NatlStmt for more details.

Final Report

AUS-47 indicates that for trials conducted under the Clinical Trial Approval (CTA) scheme, the CTA clinical trial completion advice form ( AUS-58 ) is used to notify the Therapeutic Goods Administration (TGA) of the trial completion. AUS-58 indicates that upon completion, the form may be emailed to the TGA at [email protected] (preferred) or faxed to 02 6232 8112.

Per AUS-49 , for trials conducted under the Clinical Trial Notification (CTN) scheme, a completion advice should be submitted through the TGA Business Services (TBS) webpage ( AUS-36 ). The completion advice must include the date the trial was completed at all Australian sites, as well as the completion reason. See AUS-49 for additional information on the completion advice.

The AU-ICH-GCPs and the G-TrialsSOP indicate that the investigator should provide the EC with a final clinical study report. As per the G-TrialsSOP , the investigator must also notify the research governance officer that the trial has been terminated/closed. At the completion of the project, a report with the same information as described above for progress reports (per G-NatlStmt ) must also be provided to the relevant EC(s) and institution(s), but it should include information on the outcome of the completed research.

As per the AU-ICH-GCPs and the G-TrialsSOP , a sponsor is defined as an individual, company, institution, or organization that takes responsibility for the initiation, management, and/or financing of a clinical trial. As stated in the AU-PIC-S-GMP-Guide , sponsors undertake the ultimate responsibility for all aspects of the clinical trial, including the quality of investigational products (IPs).

In accordance with the AU-ICH-GCPs , Australia permits a sponsor to transfer any or all of its trial-related duties and functions to a contract research organization (CRO). Any trial-related duties and functions transferred to a CRO should be specified in a written agreement, and the sponsor should ensure oversight of such transferred responsibilities. Any trial-related duties and functions not specifically transferred to and assumed by a CRO are retained by the sponsor. The AU-ICH-GCPs further indicates that the sponsor retains overall responsibility for the trial data’s quality and integrity, as well as the conduct of the trial. As stated in the G-TrialsSOP , the sponsor is also responsible for ensuring that appropriate approvals are obtained prior to the commencement of the clinical trial, that conditions of any approvals are adhered to during the course of the clinical trial, and that the ethics principles of research merit and integrity, justice, beneficence, and respect are applied to the conduct of clinical trials.

According to the G-CTHandbook , if the investigator initiates and organizes the trial, the role of trial sponsor is assumed. If another party (such as a pharmaceutical company) provides the IP or other support for an investigator-led trial, that party is not required to assume the sponsor role.

As per the G-CTHandbook , the G-TrialsSOP , and AUS-47 , a sponsor must be an Australian entity.

As set forth in the AU-ICH-GCPs , the sponsor should select the investigator(s) and the institution(s) for the clinical trial, taking into account the appropriateness and availability of the study site and facilities. The sponsor must also ensure that the investigator(s) are qualified by training and experience. Prior to entering into an agreement with the investigator(s) and the institution(s) to conduct a study, the sponsor should provide the investigator(s) with the protocol and an investigator’s brochure.

According to the G-TrialsSOP , the principal investigator (PI) must ensure that all required staff who assist with the clinical trial are informed about and trained on the protocol, any investigational product (IP), and their research-related duties and functions. This can be in the form of an initiation meeting held by any communication means, including face-to-face, videoconference, telehealth, etc. The PI must also have sufficient time to properly conduct and complete the research within the specified period, as well as an adequate number of qualified staff and adequate facilities for the foreseen duration of the research. When a teletrial is being conducted, the PI, who is always at the primary site and never at the satellite site, remains responsible for the trial across the cluster. For more information on PI site staff training and qualification requirements, see the G-TrialsSOP .

See AUS-64 for additional clinical trial and researcher resources.

The G-NatlStmt indicates that institutions must ensure that any human research for which they are responsible is designed, reviewed, approved, authorized, conducted, and monitored in accordance with the G-CodeConduct and the G-NatlStmt , along with any policies that they have developed that form part of their research governance framework. Each institution should be satisfied that the human research for which it is responsible meets both relevant ethical standards and scholarly or scientific standards, and ensure that those conducting the research (i) are either adequately experienced and qualified, or supervised; (ii) understand the need to assess risks to their own safety and that of participants; and (iii) are aware they are free to withdraw from research on conscientious grounds. Institutions should publish (such as on their website) clear policies and procedures for ethics review and approval and institutional authorization of research. They may establish their own processes for ethics review of research or use the review processes of another institution or external ethics review body.

Per AUS-63 , the Australian Commission on Safety and Quality in Health Care developed the National Clinical Trials Governance Framework ( AUS-63 ), which embeds clinical trials into routine health service provisions and strengthens the clinical and corporate governance arrangements for parties that deliver clinical trials. All jurisdictions have agreed to implement the framework in health service organizations, meaning the organizations will be assessed concurrently for clinical and corporate services and clinical trial service provisions. The framework describes the systems and processes that should be in place to implement an effective governance system considering local needs, values, and the context in which services are provided. For more information about implementation timing and assessments under the National Safety and Quality Health Service (NSQHS) standards, see AUS-63 .

Foreign Sponsor Responsibilities

Data Safety Monitoring Boards

G-DSMB indicates that the sponsor may establish a Data Safety Monitoring Board (DSMB) to review accumulating trial data in order to monitor the progress of a trial. The role of a DSMB is to provide advice on safety and/or trial conduct issues by making recommendations to the sponsor or trial steering committee on whether to continue, modify, or stop a trial. Per the AU-ICH-GCPs , the DSMB should have written standard operating procedures (SOPs) and maintain written records of all its meetings.

According to the G-TrialsSOP , the sponsor may utilize a DSMB or independent individuals (e.g., a medical monitor) to:

• Review accruing trial safety data in either an unblinded or blinded manner to assess treatment exposure
• Access, assess, and review emerging efficacy data for the trial
• Assess the balance of risks and benefits within the trial
• Document the outcome of these reviews

Multicenter Studies

As delineated in the AU-ICH-GCPs , in the event of a multicenter trial, the sponsor must ensure that:

• All investigators conduct the trial in strict compliance with the protocol that was agreed to by the sponsor and the Therapeutic Goods Administration (TGA) (if required), and that was approved by the ethics committee (EC)
• The case report forms (CRFs) capture the required data at all multicenter trial sites
• The responsibilities of coordinating investigator(s) and the other participating investigators are documented prior to the start of the trial
• All investigators are given instructions on following the protocol, on complying with a uniform set of standards to assess clinical and laboratory findings, and on completing the CRFs
• Communication among investigators is facilitated

As noted in the G-TeletrialPrncpls , Australian jurisdictions agree that “traditionally” multicenter clinical trials assume one (1) PI per geographic site, differing from teletrials. However, for the purposes of teletrials, multicenter trials may include some sites that have satellite sites supervised under teletrial guidance, including the Clinical Oncology Society of Australia (COSA) ’s Australasian Tele-trial Model ( AUS-2 ), the G-TeletrialPrncpls , and the G-TrialsSOP . Sponsor responsibilities in teletrials, as described in the G-TrialsSOP , are discussed throughout the Australia profile alongside other clinical trial regulations and guidance. See each section of the Sponsorship topic for additional applicable information.

The AU-ICH-GCPs and the G-NatlStmt state that the sponsor should provide insurance in accordance with applicable regulatory requirements. In addition, according to the G-NatlStmt , institutions must ensure that sponsors have insurance arrangements in accordance with applicable regulatory requirements. The federal documents cited here do not explicitly require insurance.

Per the G-GovHndbk , the institution and investigator are responsible for managing risks of any proposed research, including providing appropriate insurance coverage.

Compensation

Injury or Death

According to the G-NatlStmt , institutions must ensure that sponsors have indemnity and compensation arrangements in accordance with applicable regulatory requirements, and that arrangements are in place to compensate trial participants for harm resulting from negligence in research. The AU-ICH-GCPs further indicates that the sponsor must explain to participants the compensation and/or treatment available to them in the event of trial-related injuries. The federal documents cited here do not explicitly require indemnity.

The G-TrialsSOP states that if the investigator is notified or becomes aware that a trial participant intends to make a claim against the institution or sponsor for injuries arising as a result of participating in a clinical trial undertaken at the institution (or any of the satellite sites under supervision by the institution in a teletrial), the investigator must promptly notify the following parties in writing that such an action is intended:

• The institution’s authority
• The coordinating principal investigator (CPI)/principal investigator (PI)/associate investigator, as relevant
• The sponsor

In addition, if the institution is notified or becomes aware that a trial participant intends to make a claim for compensation against the institution or sponsor for injuries arising as a result of participating in a clinical trial undertaken at the institution (or any of the satellite sites under supervision by the institution in a teletrial), the institution must promptly notify the institution’s insurer in writing that such an action is intended.

See AUS-39 for indemnity and injury compensation guidelines for commercially-sponsored trials.

Trial Participation

The G-NatlStmt states that it is generally appropriate to reimburse participants for the costs associated with taking part in research including travel, accommodations, and parking. Sometimes participants may also be paid for time involved. However, payment may not be disproportionate to the time involved, or include other incentives that encourage participants to take risks. Further, payment or reimbursement decisions should consider customs and practices of the community in which the trial will be conducted.

According to the G-ResearchPayment , any proposal for payment of participants should be considered by the ethics committee (EC) reviewing the research. The EC should be provided with a payment plan that includes:

• A rationale for the proposed payments
• The method and timing of any disbursements, including how they have been calculated, and
• Information about how prospective participants will be advised of the provision of payment

Payment of participants is ethically appropriate if it is equitable and proportionate to the burden of the research, and does not:

• Undermine a participant’s capacity to provide voluntary and informed consent
• Unduly influence a participant to accept a risk or burden that is greater than they would otherwise accept in everyday living or to compromise their fundamental values
• Unduly influence a participant to make false representations about or conceal information that is relevant to their eligibility for the research, their contribution to the research, or the risks related to participation

To minimize the likelihood of a payment acting as an undue influence, the G-ResearchPayment further indicates that payment of participants should generally be limited to reimbursement of documented expenses and remuneration for time and inconvenience. Payment may be offered as an incentive to participate in cases where the research offers little or no benefit to individuals or where the research requires the participation of target populations that are difficult to recruit. In these cases, adequate processes must be in place to promote valid consent. For more information and examples of payment models, see the G-ResearchPayment .

According to the AU-ICH-GCPs , payments to a participant should be prorated and not wholly contingent on completion of the trial by the participant.

Post-Trial Access

Per the G-NatlStmt , researchers must make clear to the participant if there are any intended therapeutic benefits from the trial, and if the treatment will be available only through participation in the trial. In addition, researchers must make it clear to the participant whether they will have access to the treatment or information they received after completion of the trial.

Quality Assurance/Quality Control

As per the TGR and the AU-ICH-GCPs , the sponsor should implement a system to manage quality throughout all stages of the trial process, focusing on trial activities essential to ensuring participant protection and the reliability of trial results.

According to the AU-ICH-GCPs , the quality management system should use a risk-based approach that includes:

• Identifying processes and data that are critical to ensure participant protection and the reliability of trial results during protocol development
• Identifying risks to critical trial processes and data
• Evaluating the identified risks against existing risk controls
• Deciding which risks to reduce and/or accept
• Documenting quality management activities and communicate to those involved in or affected by these activities
• Periodically reviewing risk control measures to ascertain whether the implemented quality management activities are effective and relevant
• Describing the quality management approach implemented in the trial and summarize important deviations from the predefined quality tolerance limits and remedial actions taken in the clinical study report

The G-RBMgmtMntring provides further guidance on the application of risk-based trial processes, particularly as a reference to sponsors of non-commercial trials.

The AU-ICH-GCPs further indicates that the sponsor is responsible for implementing and maintaining quality assurance (QA) and quality control (QC) systems with written standard operating procedures (SOPs) to ensure that trials are conducted and data generated, recorded, and reported in compliance with the protocol, the AU-ICH-GCPs , and the applicable regulatory requirements. The sponsor is responsible for obtaining agreement from all involved parties to ensure direct access to all trial-related sites, source data/documents, reports for monitoring and auditing purposes, and inspection by domestic and foreign regulatory authorities. The sponsor should implement a system to manage quality throughout all stages of the trial process, and QC should be applied to each stage of data handling to ensure that all data are reliable and have been correctly processed. Any agreements between the sponsor and investigator, or with any other parties involved in the clinical trial, should be written, either within the protocol or in a separate agreement.

Responsible Research Conduct

The G-CodeConduct outlines principles, responsibilities, and expectations for institutions and researchers to facilitate responsible research practices. Australian institutions must establish and maintain good governance and management practices for responsible research conduct. In addition, researchers must comply with the relevant laws, regulations, disciplinary standards, ethics guidelines, and institutional policies related to responsible research conduct. Compliance with the G-CodeConduct is a requirement to receiving funding from the National Health and Medical Research Council (NHMRC) or the Australian Research Council (ARC) .

The G-CodeBreaches describes the preferred model for institutions to use to investigate and manage potential code breaches, to determine any corrective actions, and when a finding of research misconduct may be made. The Australian Research Integrity Committee uses the G-CodeBreaches as a guide for reviewing how NHMRC- and ARC-funded institutions manage potential code breaches.

The G-RptBreachGCP requires the sponsor to notify the reviewing ethics committee (EC) (Human Research Ethics Committee (HREC) in Australia) within seven (7) days of confirming a serious breach of good clinical practice (GCP). A serious breach is defined as one that is likely to affect to a significant degree: the safety or rights of a trial participant or the reliability and robustness of the data generated in the trial. Sponsors should also develop documented processes for managing serious breaches. The G-TrialsSOP notes that although all deviations or breaches of the protocol must be reported by the investigator to the sponsor, only serious breaches must be reported to the EC. Serious breaches should also be reported by the principal investigator (PI) to their institution, as they may have an impact on medico-legal risk, the responsible conduct of research, or adherence to contractual obligations.

The supplementary guidance G-RptBreachGCP should be read alongside the G-CodeConduct and the G-CodeBreaches .

Monitoring Requirements

As part of its QA system, the AU-ICH-GCPs notes that the sponsor should ensure the trial is monitored and audited. The purpose of the audit should be to evaluate trial conduct and compliance with the protocol, SOPs, the AU-ICH-GCPs , and other applicable regulatory requirements. The sponsor should appoint auditors to review the clinical trial. The sponsor should ensure that the auditors are qualified by training and experience, and the auditor’s qualifications should be documented. The sponsor must also ensure that the audit is conducted in accordance with its own SOPs and that the auditor’s observations are documented.

Per the G-TrialsSOP , the PI must ensure audit/inspection readiness throughout the study, have oversight of any audit or inspection of the trial at both primary and satellite sites, and ensure any deficiencies identified through audit or inspection are actively managed to ensure continuous improvement.

The TGR further states that the sponsor must provide a written assurance to comply with any trial-related requests by an authorized Therapeutic Goods Administration (TGA) officer(s), which includes allowing inspection of clinical trial sites. The PI is required to comply with requests and answer any questions the authorized officer(s) may have.

Premature Study Termination/Suspension

As per the G-CTHandbook , procedures following the TGA’s revocation of approval under the Clinical Trial Approval (CTA) scheme or a breach of the conditions of the Clinical Trial Notification (CTN) scheme would be determined on a case-by-case basis based on the impact on participants and their ongoing safety. The AU-ICH-GCPs states that if a trial is prematurely terminated or suspended, the sponsor should promptly inform the investigator(s), institution(s), the EC, and the TGA. The sponsor should provide the reason(s) for the termination or suspension. Additionally, as indicated in the G-CTHandbook , the sponsor must notify all sites in the case of a multicenter trial. A lead EC in a multicenter study will need to liaise with the sites and sponsor when determining which, if any, are affected and the actions they need to apply.

According to the G-TrialsSOP , if a trial is prematurely terminated or suspended for any reason, the investigator must:

• Promptly inform the sponsor, EC, research governance officer, associate investigator, any satellite site, and the TGA by providing a detailed written explanation of the premature termination or suspension
• Promptly inform the trial participant and the participant’s primary care physician where the trial participant has consented, of the termination or suspension and, if applicable, of the investigational product (IP) and dose that was administered
• Assure appropriate therapy and follow up for the participant’s continued care

As per the G-NatlStmt , if an institution or EC considers that suspension of research is necessary, the instruction to stop should come from the management of the institution. Where ethics approval for a research project is suspended:

The institution must ensure that the researcher promptly suspends the research and makes arrangements to meet the needs of participants, such as ensuring that appropriate counselling support or the provision of standard care continues

The research may not be resumed unless: (i) the research is modified to provide sufficient protection or participants or address the concerns that led to the suspension; or (ii) the researcher establishes to the satisfaction of the EC that continuation of the research will not compromise participants’ welfare; and (iii) the institution authorizes the continuation of the research

The G-NatlStmt further indicates that if ethics approval for a research project is withdrawn, the researcher must promptly halt the research, make arrangements to meet the needs of participants, and notify the institution that these steps have been taken.

Electronic Data Processing System

When using electronic trial data handling systems, the sponsor must ensure and document that the electronic data processing system conforms to its established requirements for completeness, accuracy, reliability, and consistent intended performance, and that standard operating procedures (SOPs) are maintained for using these systems. Refer to the AU-ICH-GCPs for additional information.

Records Management

According to the G-CodeConduct and the G-DataInfoMgt , institutions must provide access to facilities for the safe and secure storage and management of research data, records, and primary materials.

The G-DataInfoMgt requires that institutional policy include guidance for managing research data and primary materials that addresses the following:

• Ownership, stewardship, and control
• Storage, retention, and disposal
• Safety, security, and confidentiality
• Access by interested parties

Furthermore, institutional policies on ownership of, and access to, databases and archives must require that:

• Researchers are informed of relevant confidentiality agreements and restrictions on the use of research data
• Computing systems are secure
• Information technology personnel understand their responsibilities for network security and access control
• Those holding primary material, including electronic material, understand their responsibilities for security and access

The G-CodeConduct and the G-DataInfoMgt further state that researchers must retain clear, accurate, secure, and complete records of all research including research data and primary materials. Additionally, the G-NatlStmt indicates that when multiple researchers are collaborating on the collection, storage, and/or analysis of data or information, they should agree to the arrangements for custodianship, storage, retention, and destruction of those materials, as well as the rights of access, rights to analyze/use and re-use the data or information, and the right to produce research outputs based upon them.

According to the G-TrialsSOP , the investigator must maintain adequate source documents and trial records, including all key observations on each of the trial participants. The investigator must also store all trial related documents in a study master file (SMF) and take measures to prevent accidental or premature destruction of these documents. In the case of a teletrial, the SMF is stored at the primary site, and the principal investigator (PI) must have control of all essential documents and records generated by the investigator(s), institution, and satellite site(s) before, during, and after the trial. The PI must also establish the maintenance rules of the SMF and relationship between the primary site’s SMF and any satellite site study files. For more information on the SMF, see the G-TrialsSOP .

As set forth in the annotated AU-ICH-GCPs , the Therapeutic Goods Administration (TGA) requires that the sponsor retain records for 15 years following the completion of a clinical trial. However, product liability is the overriding consideration, and the sponsor should be able to produce records at any time, including possibly beyond the life of a product, in the event of an adverse event claim. The sponsor should inform the investigator(s) and the institution(s) in writing when trial-related records are no longer needed.

Data Management Plan

According to the G-NatlStmt and the G-DataInfoMgt , researchers should create a data management plan, which should be developed as early as possible in the research process and should include details regarding:

• Physical, network, system security, and any other technological security measures
• Policies and procedures
• Contractual and licensing arrangements and confidentiality agreements
• Training for members of the project team and others, as appropriate
• The form in which the data or information will be stored
• The purposes for which the data or information will be used and/or disclosed
• The conditions under which access to the data or information may be granted to others
• What information from the data management plan, if any, needs to be communicated to potential participants

The G-NatlStmt states that in the data management plan, researchers should also clarify whether they will seek extended or unspecified consent for future research, or permission from a review body to waive the requirement for consent. In addition, the security arrangements specified in the plan should be proportional to the risks of the research project and the sensitivity of the information.

In accordance with the G-NatlStmt , researchers must comply with all relevant legal and regulatory requirements that pertain to the data or information collected, used, or disclosed as well as the conditions of the consent provided by participants. Data, information, and biospecimens used in research should be disposed of in a manner that is safe and secure, consistent with the consent obtained and any legal requirements, and appropriate to the research design.

The G-NatlStmt indicates that in the absence of justifiable ethical reasons and to promote access to the benefits of research, researchers should collect and store data, or information generated by research projects, in such a way that they can be used in future research projects. A justification must be provided when a researcher believes there are valid reasons for not making data or information accessible. More details are provided in the G-NatlStmt .

In addition, for details related to secondary use and sharing of data or information, see the G-NatlStmt .

Responsible Parties

Per AUS-70 , the PrivacyAct regulates how certain health service providing organizations collect and handle personal information, including health information. It also includes provisions that generally allow an individual to access information held about them.

According to the PrivacyAct , agencies and organizations as defined in the PrivacyAct must comply with the Act and the Australian Privacy Principles (APP), found in Schedule 1, and are referred to as APP entities.

Data Protection

Per the PrivacyAct ’s APP, an APP entity must have a clearly expressed and up-to-date policy about the management of personal information by the entity. Individuals must have the option of not identifying themselves or of using a pseudonym, and an APP entity must not collect sensitive information about an individual unless the individual consents to the collection of the information.

The APP outline further requirements for the consideration of personal information privacy; the collection of personal information; dealing with personal information; the integrity of personal information; and access to, and correction of, personal information. For the full list of APP, see Schedule 1 of the PrivacyAct .

Consent for Processing Personal Data

The PrivacyAct ’s APP indicate that if an APP entity holds personal information about an individual that was collected for a particular purpose, the entity must not use or disclose the information for another purpose unless consent is obtained from the individual. There are limited exceptions to this requirement, which can be found in Schedule 1 of the PrivacyAct .

AUS-70 notes that in certain circumstances, the PrivacyAct permits the handling of health information and personal information for health and medical research purposes, where it is impracticable for researchers to obtain individuals' consent, recognizing: the need to protect health information from unexpected uses beyond individual healthcare, and the important role of health and medical research in advancing public health. To promote these ends, the Office of the Australian Information Commissioner (OAIC) approved the National Health and Medical Research Council (NHMRC) ’s legally binding guidelines, G-PrivacyAct95 and G-PrivacyAct95A , which researchers must follow when handling health information for research purposes without individuals' consent. The guidelines also assist ethics committees (ECs) (known as the Human Research Ethics Committees in Australia) in deciding whether to approve research applications. The guidelines are:

• G-PrivacyAct95 , which sets out procedures that ECs and researchers must follow when personal information is disclosed from a federal agency for medical research purposes
• G-PrivacyAct95A , which provides a framework for ECs to assess proposals to handle health information held by organizations for health research (without individuals' consent). It ensures that the public interest in the research activities substantially outweighs the public interest in the protection of privacy

See the PrivacyAct , the G-PrivacyAct95 , and the G-PrivacyAct95A for more information.

Obtaining Consent

In all Australian clinical trials, valid consent is required from each participant in accordance with the requirements set forth in the AU-ICH-GCPs and the G-NatlStmt . According to the AU-ICH-GCPs , if requirements specified in the G-NatlStmt appear to differ from those specified in the AU-ICH-GCPs , the Therapeutic Goods Administration (TGA) recommends compliance with the G-NatlStmt .

As per the AU-ICH-GCPs , the informed consent form (ICF) (also referred to as a participant information sheet and consent form (PICF) in Australia) is viewed as an essential document that must be reviewed and approved by an institutional ethics committee (EC) (known as a Human Research Ethics Committee in Australia) and kept on file before the trial commences. (See the Required Elements section for details on what should be included in the form.)

According to the G-TrialsSOP , the principal investigator (PI) for any research project retains overall responsibility for ensuring a participant’s consent has been obtained in the correct manner prior to the participant’s entry into the project. This includes where consent is obtained from participants at satellite sites in a teletrial. The PI can delegate the duty for obtaining consent to a suitably qualified associate investigator at the PI’s discretion, but the PI remains responsible for any delegated activity. Furthermore, the investigator must ensure that institutional authorization is obtained, inclusive of approval by an appropriate EC, for all written information and any other media used to provide information to potential participants prior to their usage to obtain consent from any participant.

The AU-ICH-GCPs states that the investigator must provide detailed research study information to the participant or legal representative/guardian. The ICF content should be as non-technical as practical and understandable to the participant or legal representative/guardian. The G-TrialsSOP further indicates that the ICF and relevant EC-approved participant information documents can be provided in person, by telehealth, or by telephone and email or weblink. If informed consent is obtained by telephone, this must be recorded on the ICF and in the participant’s health and medical record, and/or source document, stating (as an example): “The protocol was discussed with [participant’s name] via telephone on [DD/MM/YYYY].”

According to the G-TrialsSOP , e-consent may be the preferable option for teletrials, as consent signatures can be obtained contemporaneously at both primary and satellite sites. For more information on obtaining consent using telehealth, see the G-TrialsSOP .

As per the AU-ICH-GCPs , the ICF content should be clearly presented orally, or in a written language that is easy to understand, and commensurate with the age and comprehension level of the research participant. The participant and legal representative/guardian should also be given adequate time to consider whether to participate. According to the G-NatlStmt , information should also be presented to potential participants in ways that help them make informed choices. To this end, the researcher should take into account cultural and language barriers, the need for accurate and reliable translation, the participant’s educational background, the participant’s age and maturity level, and whether there is a visual, hearing, or communication impairment. See AUS-65 for researcher guidance on how to talk to potential participants.

Furthermore, as delineated in the G-TrialsSOP , the PI or delegate must assess the potential participant’s understanding of what they are agreeing to, that they are aware of the purpose of the study, what will be involved, and any risks that may exist. The participants must demonstrate that they fully understand the implications of decisions that may be made within the course of the research.

Per the G-NatlStmt , where a potential participant lacks the capacity to consent, a person or appropriate statutory body exercising lawful authority for the potential participant should be provided with relevant information and decide whether the individual will participate. That decision must not be contrary to the individual’s best interests. Researchers should bear in mind that the capacity to consent may fluctuate, and even without that capacity, people may have some understanding of the research and the benefits and burdens of their participation. Additionally, within some communities, decisions about participation in research may involve not only individuals but also properly interested parties such as formally constituted bodies, institutions, families, or community elders. See the Emergencies, Vulnerable Populations, Children/Minors, Prisoners, and Mentally Impaired sections for additional information about these populations.

As per the AU-ICH-GCPs , none of the oral and written information concerning the research study, including the written ICF, should contain any language that causes the participant or legal representative/guardian to waive or to appear to waive their legal rights, or that releases or appears to release the investigator(s), the institution, the sponsor, or their representative(s) from liability for negligence. Per the G-NatlStmt , no person should be subject to coercion or pressure in deciding whether to participate in a trial.

The G-NatlStmt indicates that consent may be:

• Specific – limited to the specific project under consideration
• Extended – given for the use of data or tissue in future research projects that are: (i) an extension of, or closely related to, the original project; or (ii) in the same general area of research (for example, genealogical, ethnographical, epidemiological, or chronic illness research)
• Unspecified – given for the use of data or tissue in any future research

The G-NatlStmt further states that when unspecified consent is sought, its terms and wide-ranging implications should be clearly explained to potential participants. When such consent is given, its terms should be clearly recorded. Subsequent reliance, in a research proposal, on existing unspecified consent should describe the terms of that unspecified consent. See the G-NatlStmt for more information on consent to future use of data and tissue in research. Additionally, see the Consent for Specimen section for more information on consent related to use of tissue in research.

According to the AU-ICH-GCPs and the G-TrialsSOP , any change in the ICF that is relevant to the participant’s consent should be approved by the EC prior to implementing any changes. The participant or legal representative/guardian should also be informed in a timely manner if new information becomes available that may be relevant to the participant’s willingness to continue participation in the trial. The communication of this information should be documented. The G-TrialsSOP further specifies that unless there is a significant safety concern, ECs will not usually require that participants be recontacted immediately since there are potential implications related to blinding. If approved by the EC, continued consent may be obtained verbally and recorded in the participant’s medical records and relevant documents. Re-consent may also be obtained by telephone if approved by an EC.

The G-NatlStmt notes that in some research, consent may occasionally need to be renegotiated or confirmed, especially where projects are complex or long-running, or participants are vulnerable. Research participants should be told if there are changes to the terms to which they originally agreed and given the opportunity to continue their participation or withdraw.

Language Requirements

Pursuant to the G-NatlStmt , methods for presenting research information to participants should take into account the need for accurate and reliable translation into the participant’s first language or dialect, as well as culture and its effects on the communication process. According to the G-TrialsSOP , in cases where translation is required, a professional interpreter should facilitate the process.

Documenting Consent

The AU-ICH-GCPs and the G-TrialsSOP state that the participant or legal representative(s)/guardian(s) and the investigator(s) must sign and date the ICF. Where the participant is unable to read or the legal representative/guardian is unable to read, an impartial witness should be present during the entire informed consent discussion. After the following steps have occurred, the witness should sign and date the ICF attesting that the information in the ICF was accurately explained to, and apparently understood by the participant or legal representative/guardian:

• The written ICF and any other written information to be provided to the participant is read and explained to the participant or legal representative/guardian
• The participant or legal representative/guardian has orally consented to the participant’s involvement in the trial, and has signed and dated the ICF, if capable of doing so

Before participating in the study, the participant or legal representative/guardian should receive a copy of the signed and dated ICF.

The G-TrialsSOP further indicates that where consent is obtained by telehealth or telephone, once the ICF is signed and dated by both the participant and the investigator (and any other person present, for example an interpreter), the participant must select the statement identifying that consent was obtained by telehealth or telephone with the name of the investigator. Similarly, the investigator must select the statement identifying that consent was obtained by telehealth or telephone with the name of the participant. For more information on informed consent documentation, see the G-TrialsSOP .

According to the G-NatlStmt , consent may be expressed orally, in writing, or by some other means (such as return of a survey or conduct implying consent), depending on the nature, complexity, and level of risk of the research, and the participant’s personal and cultural circumstances.

Waiver of Consent

The G-NatlStmt specifies that although voluntary consent is a requirement for every trial, the EC may approve an alteration to the consent requirements. Limited disclosure to participants of the aims and/or methods of research may be justifiable. However, only an EC can review and approve research that involves active concealment or planned deception or aims to expose illegal activity.

Per the G-NatlStmt , it may be appropriate to use an opt-out approach for participant recruitment when obtaining explicit consent is neither practical nor feasible. An opt-out approach is a method used in the recruitment of research participants where information is provided to the potential participant regarding the research and their involvement, and where their participation is presumed unless they take action to decline to participate. An EC may approve the use of an opt-out approach for research if the study satisfies all of the following conditions:

• It involves only low risk to participants
• The public interest in the proposed activity substantially outweighs the public interest in the protection of privacy
• The research activity is likely to be compromised if the participation rate is not near complete, and the requirement for explicit consent would compromise the necessary level of participation
• Reasonable attempts are made to provide participants with appropriate plain language information explaining the nature of the information to be collected, the purpose of collecting it, and procedure to decline participation or withdraw from the research
• A reasonable time period is allowed between the provision of information to prospective participants and the use of their data so that an opportunity for them to decline to participate is provided before the research begins
• A mechanism is provided for prospective participants to obtain further information and decline to participate
• The data collected will be managed and maintained in accordance with relevant security standards
• There is a governance process in place that delineates specific responsibility for the project and for the appropriate management of the data
• The opt-out approach is not prohibited by state, federal, or international law

According to the G-NatlStmt , only an EC may grant a waiver of consent for research using personal information in medical research, or personal health information. However, other review bodies may grant a waiver of consent for other research. In order to help maintain public confidence in the research process, each institution must make publicly accessible summary descriptions of all its research projects for which consent has been waived.

As stated in the G-NatlStmt , an EC may waive the requirement for consent if the study satisfies all of the following conditions:

• Involvement in the research carries no more than low risk to participants
• The benefits from the research justify any risks of harm associated with not seeking consent
• It is impracticable to obtain consent (for example, due to the quantity, age, or accessibility of records)
• There is no known or likely reason for thinking that participants would not have consented if they had been asked
• There is sufficient protection of their privacy
• There is an adequate plan to protect the confidentiality of data
• There is, where practicable, a plan for making information arising from the research available to participants in cases where the results have significance for their welfare
• The possibility of commercial exploitation of derivatives of the data or tissue will not deprive the participants of any financial benefits to which they would be entitled
• The waiver is not prohibited by state, federal, or international law

See the G-NatlStmt for more information on conditions for the opt-out approach or waiving consent.

Based on the AU-ICH-GCPs and the G-NatlStmt , both the informed consent discussion and the written informed consent form (ICF) (also referred to as a participant information sheet and consent form (PICF) in Australia) should include the following statements or descriptions, as applicable (Note: Each of the items listed below will not necessarily be found in both sources, which provide overlapping and unique elements):

• That the trial involves research
• The purpose of the trial
• The trial treatment(s) and the probability for random assignment to each treatment
• The trial procedures to be followed, including all invasive procedures
• The participant's responsibilities
• Those aspects of the trial that are experimental
• The reasonably foreseeable risks or inconveniences to the participant and, when applicable, to an embryo, fetus, or nursing infant
• The reasonably expected benefits, including to the wider community. When there is no intended clinical benefit to the participant, the participant should be made aware of this
• The alternative procedure(s) or course(s) of treatment that may be available to the participant, and their important potential benefits and risks
• The compensation and/or treatment available to the participant in the event of trial-related injury, including provision of services to participants adversely affected by the research
• The amounts and sources of funding for the research, as well as financial or other relevant declarations of interests of researchers, sponsors, or institutions
• The anticipated prorated payment, if any, to the participant for participating in the trial
• The anticipated expenses, if any, to the subject for participating in the trial
• That participation in the trial is voluntary and that the participant may refuse to participate or withdraw from the trial, at any time, without penalty or loss of benefits to which the subject is otherwise entitled
• Any implications of withdrawal from the trial, and whether it will be possible to withdraw data
• How the research will be monitored
• That the monitor(s), the auditor(s), the ethics committee (EC), and the regulatory authority(ies) will be granted direct access to the participant's original medical records for verification of clinical trial procedures and/or data, without violating the confidentiality of the participant, to the extent permitted by the applicable laws and regulations and that, by signing a written informed consent form, the participant or legal representative/guardian is authorizing such access
• That records identifying the participant will be kept confidential and, to the extent permitted by the applicable laws and/or regulations, will not be made publicly available. If the results of the trial are published, the participant’s identity will remain confidential
• That the participant or legal representative/guardian will be informed in a timely manner if information becomes available that may be relevant to the participant's willingness to continue participation in the trial
• The person(s) to contact for further information regarding the trial and the rights of trial participants, and whom to contact in the event of trial-related injury
• Contact details of a person to receive complaints and of the researchers
• The foreseeable circumstances and/or reasons under which participation in the trial may be terminated
• The expected duration of participation in the trial
• The approximate number of participants involved in the trial
• The likelihood and form of dissemination of the research results, including publication
• Any other relevant information, including research-specific information required under other chapters of the G-NatlStmt

In accordance with the AU-ICH-GCPs and the G-NatlStmt , Australia’s ethical standards protect participants’ rights and promote respect for human beings, research merit and integrity, justice, and beneficence. The G-NatlStmt further recognizes that state or territory authorities may have additional statutes regarding the use of human tissues, guardianship, and illegal and unprofessional conduct. Furthermore, a participant’s rights must be clearly addressed in the informed consent form (ICF) (also referred to as a participant information sheet and consent form (PICF) in Australia).

The Right to Participate, Abstain, or Withdraw

As stated in the AU-ICH-GCPs and the G-NatlStmt , the participant or the legal representative/guardian should be informed that participation is voluntary, that the participant may withdraw from the research study at any time, and that refusal to participate will not involve any penalty or loss of benefits to which the participant is otherwise entitled. The G-TrialsSOP further specifies that participants may withdraw their consent at any time without giving a reason.

Per the G-NatlStmt , the participant should be informed of any implications of withdrawal and whether it is possible to withdraw data.

The Right to Information

As per the AU-ICH-GCPs and the G-NatlStmt , a potential research participant or the legal representative/guardian has the right to be informed about the nature and purpose of the research study, its anticipated duration, study procedures, any potential benefits or risks, any compensation or treatment in the case of injury, and any significant new information regarding the research study.

The Right to Privacy and Confidentiality

According to the AU-ICH-GCPs and the G-NatlStmt , all participants must be afforded the right to privacy and confidentiality, and the ICF must provide a statement that recognizes this right. Privacy is also subject to national, state, and territory laws, including the PrivacyAct . As per the G-TrialsSOP , if telehealth is used, all measures must be taken to ensure privacy and confidentiality of the participant’s identity.

See the Personal Data Protection section for more details on personal information collection and handling requirements.

The Right of Inquiry/Appeal

The AU-ICH-GCPs and the G-NatlStmt state that the research participant or the legal representative/guardian should be provided with contact information for the individual responsible for addressing trial-related inquiries and/or rights.

AUS-45 provides information on who the participant or the legal representative/guardian may contact regarding a concern with the clinical trial. The options include contacting the researcher(s) directly, the ethics committee (EC) (known as Human Research Ethics Committee in Australia), the institution, the healthcare complaints entity in the state or territory, or the National Health and Medical Research Council (NHMRC) . Concerns may also be reported to the Therapeutic Goods Administration (TGA) . See AUS-45 for more information on the types of concerns that may be reported to each party.

See the G-NatlStmt for more information on institutional requirements for receipt of complaints.

The Right to Safety and Welfare

The AU-ICH-GCPs (which upholds the Declaration of Helsinki ( AUS-52 )) and the G-NatlStmt clearly state that a research participant’s right to safety and protection of health and welfare must take precedence over the interests of science and society.

See the Required Elements and Vulnerable Populations sections for additional information regarding requirements for participant rights.

The AU-ICH-GCPs states that in emergency situations, when prior consent of the participant is not possible, the consent of the legal representative/guardian, if present, should be requested. When prior consent of the participant is not possible, and the legal representative/guardian is not available, enrollment of the participant should require measures described in the protocol and/or elsewhere, with documented approval/favorable opinion by the ethics committee (EC) (known as the Human Research Ethics Committee in Australia), to protect the rights, safety, and well-being of the participant and to ensure compliance with applicable regulatory requirements, including the G-NatlStmt . Per the AU-ICH-GCPs , the participant or legal representative/guardian should be informed about the trial as soon as possible, and consent to continue and other consent should be requested, as appropriate.

The G-NatlStmt recognizes that in emergency care research, recruitment into a research project often must be achieved rapidly. Where the research involves emergency treatment and meets the G-NatlStmt ’s requirements for research involving people highly dependent on medical care, consent for the research may be waived. See the Vulnerable Populations section for more information on people highly dependent on medical care, and the Documentation Requirements section for more details on waiver of consent.

The AU-ICH-GCPs characterizes vulnerable populations as those who may be unduly influenced by the expectation, whether justified or not, of benefits associated with participation in a clinical trial, or of a retaliatory response for not participating. Examples are members of a group with a hierarchical structure, such as medical, pharmacy, dental, and nursing students, subordinate hospital and laboratory personnel, employees of the pharmaceutical industry, members of the armed forces, and persons kept in detention. Other vulnerable subjects include patients with incurable diseases, residents of nursing homes, unemployed or impoverished persons, patients in emergency situations, homeless persons, nomads, refugees, minors, and those incapable of giving consent. Per the G-NatlStmt , people who may be involved in illegal activities, Aboriginal and Torres Strait Islander peoples, ethnic minority groups, and people in other countries are other groups for which specific ethical considerations are required.

People Highly Dependent on Medical Care

According to the G-NatlStmt , research involving people who are highly dependent on medical care may be approved where:

• It is likely that the research will lead to increased understanding about, or improvements in, the care of this population
• The requirements of relevant jurisdictional laws are taken into account
• Either: 1) any risk or burden of the proposed research to this particular participant is justified by the potential benefits, or 2) where participants have capacity to consent, any risk or burden is acceptable to them and justified by the potential benefits of the research

The G-NatlStmt indicates that when a researcher is also the treating health professional, it should be considered whether an independent person should seek the consent of potential participants who are highly dependent on medical care. In addition, the participant and/or the participant’s relatives and an authorized representative should be informed of the participant’s inclusion in the research and of the option to withdraw from it without any reduction in quality of care.

The G-NatlStmt states that when neither the potential participant nor the legal representative/guardian can consider the proposal and give consent, an ethics committee (EC) (known as the Human Research Ethics Committee in Australia) may, having taken account of relevant jurisdictional laws, approve a research project without prior consent if:

• There is no reason to believe that, were the participant or legal representative/guardian to be informed of the proposal, the participant would be unwilling to consent
• The risks of harm to individuals, families, or groups linked to the participant, or to their financial or social interests, are minimized
• The project is not controversial and does not involve significant moral or cultural sensitivities in the community

And, where the research is interventional, these additional conditions apply:

• The research supports a reasonable possibility of benefit over standard care
• Any risk or burden of the intervention to the participant is justified by its potential benefits
• Inclusion in the research project is not contrary to the interests of the participant

The G-NatlStmt further provides specific requirements related to conducting research on participants in terminal care, which is characterized by the short remaining life expectancy of the participants and their vulnerability to unrealistic expectations of benefits. Terminal care research should be designed so that the benefits of research justify any burden, discomfort, or inconvenience to the participants; the prospect of benefit from research participation is not exaggerated; the needs and wishes of participants to spend time as they choose are respected; and the entitlement of those receiving palliative care to participate is recognized.

Aboriginal and Torres Strait Islander Peoples

The G-NatlStmt states that research involving Aboriginal and Torres Strait Islander Peoples must be reviewed and approved by an EC and include assessment and advice from: people who have networks with and/or knowledge of Aboriginal and Torres Strait Islander Peoples; and people familiar with the culture and practices of the relevant Aboriginal and Torres Strait Islander community(ies). In addition, the researcher should ensure the following:

• Research methods are respectful and acknowledge the cultural distinctiveness of participating Aboriginal and Torres Strait Islander communities and groups
• There is evidence of support for the research project from relevant Aboriginal and Torres Strait Islander communities or groups and the research methodology engages with their social and cultural practices
• The research methods provide for mutually agreed mechanisms for recruitment, information provided about the research, notification of participants’ consent and of research progress, and final reporting
• Procedures and actions have been taken to monitor and, where appropriate, minimize any potential negative consequences of the proposed research

For more information on research involving Aboriginal and Torres Strait Islander Peoples, see the G-AboriginalEthic , the G-EthicsRsrchTrackII , and the G-AIATSISCode .

People in Dependent Groups

The G-NatlStmt cautions that dependent or unequal relationships that might compromise the voluntary character of a participant’s decision should be considered. Examples of such relationships include caregivers and people with chronic conditions/disabilities; health care professionals and their patients; teachers and their students; prison authorities and prisoners; governmental authorities and refugees; employers/supervisors and their employees (including members of police and Defense Forces); and service-providers and especially vulnerable communities to whom the services are provided. Where potential participants are especially vulnerable or powerless, consideration should be given to the appointment of a participant advocate.

Per the G-NatlStmt , when a researcher and potential participant have a pre-existing relationship, it should be considered whether an independent person should seek the consent of the participant.

People Who May Be Involved in Illegal Activities

The G-NatlStmt provides specific requirements related to conducting research on participants who may be involved in illegal activities. Research that is intended to study or expose, or likely to expose, illegal activity should be reviewed and approved by an EC. Researchers should be satisfied that participants who are subject to criminal justice processes are aware that the research may discover illegal activity and do not have unrealistic expectations of benefit from their participation. Finally, research designed to expose illegal activity should only be approved where the illegal activity bears on the discharge of a public responsibility or the fitness to hold public office, the risks are justified by the benefits, and the research meets the other requirements in the G-NatlStmt .

People in Other Countries

The G-NatlStmt states that research involving people in other countries must be reviewed and approved by an EC and comply with the G-NatlStmt . The research design, protocol, and consent process should take into consideration the local cultural values, yet still result in participants being treated with no less respect and protection than what is provided in the G-NatlStmt . Additional details are provided in the G-NatlStmt .

The FamLawAct defines a child as a person who is under 18 years of age. Per AUS-71 , different states or territories may have specific legislation about a parent/guardian providing consent to medical treatment for a minor; otherwise, the FamLawAct has provisions that may apply.

According to AUS-71 , children under 16 cannot give legal consent, which must be given by a parent/guardian, but they can and should be involved in the decision. Young people over 16 can give legal consent to medical treatment; however, they usually cannot provide legal consent to participate in research until they are 18. Nonetheless, some ethics committees (ECs) (known as Human Research Ethics Committees in Australia) do allow mature young people under 18 to give their consent for some kinds of research.

The AU-ICH-GCPs states that minors should be informed to the extent compatible with their maturity and understanding, and if capable, they should sign and personally date the informed consent form (ICF) (also referred to as a participant information sheet and consent form (PICF) in Australia). In accordance with the G-NatlStmt , consent requirements for conducting clinical trials follow the general requirements listed in the Required Elements section.

The G-NatlStmt states before including a child or young person in research, researchers must establish that there is no reason to believe that such participation is contrary to that child's or young person's best interest. Furthermore, a child or young person's refusal to participate in research should be respected wherever the child or young person has the capacity to give consent to that same research. Where a child or young person lacks this capacity, the child or young person’s refusal may be overridden by the judgement of the parent/guardian as to what is in the child's best interest.

The G-NatlStmt indicates that an EC may approve research to which only the child or young person consents if it is satisfied that:

• The child or young person is mature enough to understand the relevant information and give consent
• The research involves low risk
• The research aims to benefit children or young people
• The child or young person is estranged or separated from the parent/guardian and the researcher ensures the child or young person’s safety, security, and well-being in the research conduct; or it would be contrary to the best interests of the child or young person to seek consent from the parent/guardian, and the researcher ensures the child or young person’s safety, security, and well-being in the research conduct

In addition, as stated in the G-NatlStmt , children and young people who are not of sufficient maturity to consent should only participate in clinical studies when: the research is likely to advance knowledge about the health or welfare of, other matters relevant to, children and young people; or their participation is indispensable to the conduct of the research. When considering the inclusion of children and young people in research, the researchers and EC must consider their level of maturity to ensure adequate protections for their welfare.

Assent Requirements

AUS-71 indicates that when a parent/guardian gives consent for their child to take part in a clinical trial, researchers may also ask the child for their permission or agreement, also referred to as assent. The researchers must do this in an age-appropriate manner. Both the parent/guardian and the child should have the chance to ask any questions before agreeing to participate and at any time during a trial.

In order for a child to provide their consent or assent they must:

• Understand the research process
• Understand the purpose of the trial
• Be told what they are expected to do or what will happen to them during the trial

Children should be able to express their views and any worries they might have about participating in a trial, and have their questions answered. Children should always be given information in a form that they can understand.

Furthermore, the G-NatlStmt states that except in cases involving standing parental consent, specific consent must be obtained from the child or young person whenever the child or young person has the capacity to make this decision, and either one (1) parent, except when the EC decides that the risks require the consent of both parents, or the child or young person’s parent/guardian.

Per the G-NatlStmt , researchers must respect the developing capacity of children and young people to be involved in decisions about participation in research. The child or young person's particular level of maturity has implications for whether consent is necessary and/or sufficient to authorize participation. However, it is not possible to attach fixed ages to each level of maturity, which may vary from child to child. The following guidelines on maturity and corresponding capacity to consent are provided:

• Infants, who are unable to take part in discussion about the research and its effects
• Young children, who are able to understand some relevant information and take part in limited discussion about the research, but whose consent is not required
• Young people of developing maturity, who are able to understand the relevant information but whose relative immaturity means that they remain vulnerable; the consent of these young people is required, in addition to consent from a parent or guardian
• Young people who are mature enough to understand and consent, and are not vulnerable through immaturity in ways that warrant additional consent from a parent or guardian

See the G-NatlStmt for more information on consent and assent involving children and young people.

As per the G-NatlStmt , studies involving pregnant women, fetuses, and neonates require additional safeguards to ensure that the research assesses the risks to the pregnant women, fetuses, and neonates. The wellbeing and care of the woman who is pregnant and of her fetus always takes precedence over research considerations, and research involving a fetus or fetal tissue should be conducted in a manner that maintains a clear separation between the woman’s clinical care and the research. Additionally, research should be designed to minimize pain or distress for the fetus, include steps for monitoring for signs of fetal pain or distress, and include steps for suspending or ceasing the research if necessary.

In accordance with the G-NatlStmt , consent requirements for conducting clinical trials follow the general requirements listed in the Required Elements section . However, except for therapeutic innovative therapy cases, the process of providing information and obtaining consent for participating in research should be clearly separate from clinical care if the woman is pregnant and the fetus is in utero. Further, per the G-NatlStmt , the woman should be informed of the following:

• That she should consider whether to seek consent to the proposed research from any other person (e.g., the other parent)
• Whether it is possible to store the fetus or fetal tissues for later use in research
• That she is free to withdraw her consent to the research at any time, whether before or after a termination or other loss of a fetus
• Whether there is potential for commercial application of outcomes of the research, including the development of cell lines
• That she will not be entitled to a share in the profits of any commercial applications
• Whether fetal organs or stem cell lines developed from them will be exported to another country

In addition, the G-NatlStmt states that if, for research purposes, fetal cells are to be derived from the fetal tissue and stored or propagated in tissue culture, or tissues or cells are to be used in human transplantation, the woman's consent is required. Others whom the woman identifies may also need to be involved in decisions about these matters.

For requirements related to assisted reproductive technology, including research involving the creation of human embryos using precursor cells from a human embryo or a human fetus, see the G-EthicsART .

The G-NatlStmt refers to prisoners and prison authorities as an example of people who may be in dependent or unequal relationships.

Per the G-NatlStmt , a research study involving people in dependent or unequal relationships (such as prisoners) should, wherever possible, invite prospective participants to discuss their participation with someone who is able to support them in making their decision. If prospective participants are especially vulnerable, researchers should consider appointing a participant advocate.

Cognitive Impairment, Intellectual Disability, or Mental Illness

The G-NatlStmt discusses the requirements for research involving participants with cognitive impairment, intellectual disability, and mental illness together, noting that many of the ethical issues they raise about research participation are similar. An ethics committee (EC) (known as Human Research Ethics Committee in Australia) must review and approve research involving such participants, except where the research uses collections of non-identifiable data and involves negligible risk.

Per the G-NatlStmt , the research design should take into account factors that may affect the capacity to receive information, to consent to the research, or to participate in it. Additionally, care should be taken to determine whether the participant’s cognitive impairment, intellectual disability, or mental illness increases the susceptibility to some forms of discomfort or distress. Ways of minimizing effects of this susceptibility should be described in the research proposal.

As delineated in the G-NatlStmt , the participant must consent if the participant has the capacity, or the participant’s legal representative/guardian must consent on behalf of the participant. Where a legal representative/guardian has given consent, the researchers still must explain to the participant what the research is about and what participation involves. If the participant recovers the capacity to consent, the researcher should offer the opportunity to continue participation or withdraw. Refusal or reluctance to participate in a research project should be respected.

The G-NatlStmt states that if the participant’s impairment, disability, or illness is temporary or episodic, researchers should seek consent when the condition does not interfere with the capacity to give consent. This consent should occur in the presence of a witness who is familiar with the participant, is independent from the research, and understands the research’s merits, risks, and procedures.

Research Involving Unconscious Persons

The G-NatlStmt states when prior consent is not possible for research involving unconscious persons, consent should be provided by the participant’s legal representative/guardian. However, relevant jurisdictional laws must be taken into account. Because of their extreme vulnerability, unconscious persons should be excluded from all but minimally invasive research, or in research designed both to be therapeutic for them and to improve treatment for the condition from which they suffer.

The G-TrialsSOP notes that as per the Declaration of Helsinki ( AUS-52 ), for research involving participants who are physically or mentally incapable of giving consent (e.g., unconscious patients/participants), the study must be relevant to the physical or mental condition of the participant(s) that prevents them from being able to consent to participate in the study.

According to the AU-ICH-GCPs and the G-TrialsSOP , an investigational product (IP) is defined as a pharmaceutical form of an active ingredient or placebo being tested or used as a reference in a clinical trial. This includes a product with a marketing authorization when used or assembled (formulated or packaged) in a different way from the approved form; when used for an unapproved indication; or when used to gain further information about an approved use.

In Australia, IPs are also referred to as unapproved therapeutic goods. As per the G-CTHandbook and AUS-47 , an unapproved therapeutic good includes:

• Any medicine, biological, or medical device not entered on the Australian Register of Therapeutic Goods (ARTG) ( AUS-22 ), including any new formulation, strength or size, dose, name, indications, directions for use or type of container of a medicine already in the ARTG
• Any therapeutic good already in the ARTG to be used in a manner not covered by the existing ARTG entry

Manufacturing

As specified in the TGAct , the TGR , and the G-CTHandbook , the Therapeutic Goods Administration (TGA) authorizes the manufacture of investigational products (IPs) in Australia. As per AUS-47 and AUS-49 , the sponsor provides manufacturer and/or active ingredient information to the TGA in the clinical trial application under one (1) of the two (2) regulatory schemes—the Clinical Trial Notification (CTN) scheme or the Clinical Trial Approval (CTA) scheme. Pursuant to TGManuf , Australia adopted the Pharmaceutical Inspection Co-operation Scheme (PIC/S) Guide to Good Manufacturing Practice for Medicinal Products ( AU-PIC-S-GMP-Guide ) regarding the manufacture of therapeutic goods.

Per the AU-PIC-S-GMP-Guide , the holder of a manufacturing authorization must manufacture IPs to ensure that they are fit for their intended use, comply with the requirements of the clinical trial authorization, and do not place participants at risk due to inadequate safety, quality, or efficacy. The production of IPs involves added complexity in comparison to marketed products and therefore requires personnel with a thorough understanding of, and training in, the application of good manufacturing practice (GMP) to IPs. Cooperation with trial sponsors, who undertake the ultimate responsibility for all aspects of the clinical trial, is also required.

See the AU-PIC-S-GMP-Guide for detailed manufacturing requirements.

The G-CTHandbook and AUS-47 indicate that IPs may be imported and held under the direct control of the sponsor (importer) until the IPs are the subject of a notification to the TGA under the CTN scheme or an approval under the CTA scheme. The IPs must be kept in a warehouse or other properly secured area. There is no requirement for the CTN or CTA process to have been completed prior to importation of the clinical trial goods.

Per AUS-47 , importers are advised to contact other relevant agencies, as there may be further restrictions on importation imposed through other legislation.

Other Considerations

AUS-47 states that Australian clinical trial product importers/manufacturers are not required to provide the TGA with six (6) monthly reports under regulation 47B of the TGR . However, the TGA can require information or documents relating to the supply (including quantity) of therapeutic goods that are exempt under the CTN scheme or approved under the CTA scheme.

Investigator’s Brochure

According to the AU-ICH-GCPs , the sponsor is responsible for providing the investigators with an investigator’s brochure (IB). The IB must contain all of the relevant information on the investigational product(s) (IPs), including significant physical, chemical, pharmaceutical, pharmacological, toxicological, pharmacokinetic, metabolic, and clinical information. The sponsor must ensure that an up-to-date IB is made available to the investigator(s), and the investigator(s) must provide an up-to-date IB to the ethics committee.

According to the G-TrialsSOP , where the investigator contributes to the content and development of the IB, the investigator must ensure the IB follows the outline in the AU-ICH-GCPs . The AU-ICH-GCPs requires the IB to cover the following areas:

• Physical, chemical, and pharmaceutical properties and formulation parameters
• Non-clinical studies (pharmacology, pharmacokinetics, toxicology, and metabolism profiles)
• Effects of IP in humans (pharmacokinetics, metabolism, and pharmacodynamics; safety and efficacy; and regulatory and post-marketing experiences)
• Summary of data and guidance for the investigator(s)

See Section 7 of the AU-ICH-GCPs for detailed content guidelines.

Quality Management

As specified in the AU-ICH-GCPs , the sponsor must ensure that the products are manufactured in accordance with Good Manufacturing Practice (GMP). Furthermore, the sponsor must maintain a Certificate of Analysis to document the identity, purity, and strength of the IP(s) to be used in the clinical trial.

Per the AU-PIC-S-GMP-Guide , GMP ensures that products are consistently produced and controlled to the quality standards appropriate to their intended use and as required by the clinical trial authorization. A quality system designed, set up, and verified by the manufacturer or importer should be described in written procedures available to the sponsor, taking into account the GMP principles and guidelines applicable to IPs. Manufacturers should maintain documentation including specifications and instructions; the IP order; the product specification file; manufacturing formulae and processing instructions; packaging instructions; and processing, testing, and packaging batch records. The product specifications and manufacturing instructions may be changed during development, but full control and traceability of the changes should also be maintained.

See the AU-PIC-S-GMP-Guide for more details on quality documentation requirements.

Investigational product (IP) labeling in Australia must comply with the requirements set forth in the G-CTHandbook , the AU-ICH-GCPs , and the AU-PIC-S-GMP-Guide . Per the AU-PIC-S-GMP-Guide , as annotated by the G-CTHandbook , the following information must be included on the IP label:

• Sponsor’s name, address, and phone number. The main contact details for information on the product, clinical trial, and emergency unblinding must be an Australian contact.
• Pharmaceutical dosage form, route of administration, and quantity of dosage units. For closed blinded trials, the labeling should include a statement indicating “placebo or [name/identifier] + [strength/potency]”.
• The batch and/or code number to identify the contents and packaging operation
• A trial reference code, which should identify the particular trial site, unless provided elsewhere or its absence can be justified. The trial reference code used should also identify the Australian trial sponsor, unless provided as the main contact or its absence can be justified.
• The trial participant identification number/treatment number
• Investigator’s name. The name of the principal investigator should appear on the label unless already included in a trial reference code or unless its absence can be justified.
• Directions for use
• “For clinical trial use only” or similar wording
• The storage conditions
• The period of use (use-by date, expiry date, or re-test date as applicable) in month/year format and in a manner that avoids any ambiguity
• “Keep out of reach of children” except when the product is not taken home by participants

The G-CTHandbook recognizes that in exceptional circumstances, it may not be possible to meet the requirements of Annex 13 of the AU-PIC-S-GMP-Guide for labeling IPs. In this case, the sponsor must contact the Therapeutic Goods Administration (TGA) (see AUS-23 ) if they wish to request a departure from the requirements of Annex 13.

In addition, the AU-ICH-GCPs states that the IP must be coded and labeled in a manner that protects the blinding, if applicable.

Per the G-CTHandbook , labeling is a manufacturing step under the TGAct . However, an exemption from the requirement to hold a manufacturing license may apply to certain persons identified within the TGR , to allow relabeling of the IP with name and address of the new sponsor. If there is a change of Australian trial sponsor, the clinical trial medication should be relabeled appropriately with the details of the new trial sponsor at the time of transfer. See the G-CTHandbook for more details on these manufacturing exemptions.

Additional details on IP labeling are provided in the G-CTHandbook and the AU-PIC-S-GMP-Guide .

Supply, Storage, and Handling Requirements

As defined in the AU-ICH-GCPs and the AU-PIC-S-GMP-Guide , the sponsor must supply the investigator(s) with the investigational product(s) (IPs)), including the comparator and placebo, if applicable. The G-CTHandbook and AUS-47 indicate that Therapeutic Goods Administration (TGA) approval through the Clinical Trial Approval (CTA) scheme or notification through the Clinical Trial Notification (CTN) scheme must occur prior to supplying the IP(s) to the trial site(s).

The AU-ICH-GCPs specifies that the sponsor must ensure the following:

• Timely delivery of the IP(s)
• Records maintained for IP document shipment, receipt, disposition, return, and destruction
• A system for retrieving or disposing of IP(s) and documenting this retrieval or disposal
• Written procedures including instructions for IP handling and storage, adequate and safe receipt of the IP(s), dispensing of the IP(s), retrieval of unused IP(s), return of unused IP(s) to the sponsor, and disposal of unused IP(s) by the sponsor
• IP product quality and stability over the period of use
• IP manufactured according to any application of the Good Manufacturing Practices (GMPs)
• Proper coding packaging, and labeling of the IP(s)
• Acceptable IP handling and storage conditions and shelf-life

In addition, the AU-ICH-GCPs states that the IPs must also be suitably packaged in a manner that will prevent contamination and unacceptable deterioration during transport and storage. Refer to the AU-ICH-GCPs for detailed sponsor-related IP requirements.

As per the G-TrialsSOP , responsibility for IP management and accountability at the trial site rests with the principal investigator (PI). However, the PI may delegate responsibility for IP management to the site pharmacist or, where a pharmacist is not available or involved, to an appropriately qualified person. The site pharmacist or the appropriately qualified person will undertake IP management at the primary site and/or the satellite site in a teletrial. The investigator, pharmacist, or appropriately qualified non-pharmacist must ensure the IP is used only in accordance with the approved protocol and confirm IP certification and all relevant trial approvals/notifications are in place before releasing the IP for dispensing to participants. Refer to the G-TrialsSOP for detailed investigator-related IP requirements.

Record Requirements

According to the G-TrialsSOP , the investigator, pharmacist, or appropriately qualified non-pharmacist must maintain records of all IP management aspects. These records at a minimum should include: shipping documents; date of each transaction; quantities; batch/serial numbers; expiration dates/retest dates (if applicable); temperature logs showing the storage conditions of the IP throughout the trial period; the set of unique code numbers assigned to the IP and to the trial participant; and record of destruction/return.

As set forth in the AU-ICH-GCPs , the sponsor must retain essential documents for 15 years following completion of the trial. The sponsor should inform the investigator(s) and institution(s) in writing when record retention is needed and when the trial-related records are no longer needed.

In Australia, a specimen is referred to as a “biological” or a “human biospecimen.” According to the TGAct , a biological is made from, or contains, human cells or human tissues that are likely to be taken to:

• Treat or prevent disease, ailment, defect, or injury
• Diagnose the condition of a person
• Alter the physiological processes of a person
• Test the susceptibility of a person to disease
• Replace or modify a person’s anatomy

The G-NatlStmt defines human biospecimen as any biological material obtained from a person, including tissue, blood, urine, sputum, and any derivative from these including cell lines.

Legislation in Australian states and territories do not use standard terminology, but generally refer to human biospecimens as “human tissue.”

Per the G-NatlStmt , if a human biospecimen will be, or has been, imported for research, researchers must establish whether the human biospecimen was obtained in a manner consistent with the requirements of the G-NatlStmt and relevant Australian legislation. If this cannot be established, then the human biospecimen should not be used for research in Australia.

Per the G-CTHandbook , other legislation and requirements may impose restrictions on the import of therapeutic goods for clinical trials involving materials of biological origin (human, animal, plant, or microbial), genetically modified organisms, and other substances. See the G-CTHandbook for a non-exhaustive list.

The G-NatlStmt states that a human biospecimen obtained in Australia may be sent overseas for research if its exportation is consistent with the original consent, and if ethics committee (EC) (known as a Human Research Ethics Committee in Australia) approval is obtained.

Per the G-SpecExport , a permit to export human body fluids, organs, and other tissue must be obtained from the Therapeutic Goods Administration (TGA) when the volume of a container exceeds 50 mL. If exporting substances derived from human blood, a TGA permit is required regardless of the volume. The application form requires the reason for the request, which can include research purposes. See the G-SpecExport for more details on when export permits are required, and AUS-24 for the application forms.

The G-TrialsSOP indicates that to ensure the integrity of biological samples has been maintained, there should be evidence of the chain of custody from their point of collection through processing, storage, transport, through to disposal, with evidence of appropriate storage and transit conditions. Equipment used for processing and storage of samples (e.g., centrifuges, fridges, and freezers) should be maintained by suitably qualified persons and periodically inspected, cleaned, and calibrated to the relevant International Organization for Standardization (ISO) standard according to local policy and manufacturer’s manuals. Additionally, the investigator must ensure all study staff, who have cause to handle or ship biological substances, hold a current certificate in the International Air Transport Association (IATA) Approved, Civil Aviation Safety Authority (CASA) Certified Dangerous Goods Packaging Course. The investigator must also ensure that documentation (e.g., receipts, shipping records, order forms, and proformas) related to handling and shipment of biological specimens is maintained and filed in the respective site file.

Additional details on import and export requirements are provided in the G-CTHandbook , the G-TrialsSOP , the G-SpecExport , and AUS-24 .

In accordance with the G-NatlStmt , prior to collecting human biospecimens, consent must be obtained from the participant or legal representative/guardian. The general requirements for consent must be met, including the investigator(s) obtaining ethics committee (EC) (known as Human Research Ethics Committee (HREC) in Australia) review and approval of the proposed consent, collection, processing, storage and distribution, and disposal. This requirement pertains to human biospecimens that are collected for a specific clinical research project or are placed into a biobank for future research use.

The G-NatlStmt states that before potential participants consent to donation of their biospecimens, they should be given sufficient information about:

• The research for which their biospecimens will be used and, where extended or unspecified consent is sought, and sufficient information is provided to meet the general requirements of consent
• How their biospecimens will be stored, used, and disposed of, including any processes to be adopted that respect their personal or cultural sensitivities
• The extent to which their biospecimens will be reasonably identifiable, and how their privacy and confidentiality will be protected
• Whether the biospecimen research is likely to provide information that may be important to their health or to the health of their blood relatives or their community; and, if such information is likely to be revealed, whether they have the choice to receive this information, whether they have the choice for it to be provided to their relatives or their community, and how these will be managed
• Whether their biospecimens and associated data may be distributed to other researchers, including those outside Australia
• Their right to withdraw consent for the continued use of their biospecimens or associated data in research, and any limitations that may be relevant to their withdrawal of consent
• Any relevant financial or personal interests that those engaged in the collection, processing, storage and distribution, and use of their biospecimens may have
• Any potential for commercial application of any outcomes of the research and how this will be managed and to whom the benefits, if any, will be distributed

As stated in the G-NatlStmt , human biospecimens that were previously obtained for clinical purposes and have been retained by an accredited clinical pathology service may be used if the identity of the donor is not needed. If the donor’s identity is needed, a request for the waiver of the consent requirement to use existing collections of human biospecimens can be submitted to an EC.

The G-NatlStmt indicates that where proposed research involving the use of human biospecimens may reveal information that may be important for the health of the donors, their relatives, or their community, researchers should prepare an ethically defensible plan to describe the management of any proposed disclosure or non-disclosure of that information. An EC must approve this plan. With regard to biospecimens post-mortem, any wish expressed by a person about the use of their biospecimens post-mortem should be respected. If no such wish is discovered, researchers seeking to obtain human biospecimens post-mortem should obtain consent from the person(s) authorized by relevant legislation.

Human Genetic Research Consent Requirements

The G-NatlStmt indicates that research results and information collected for genomic research may be significant for relatives of research participants. Research including genomics will generally require review by an EC. However, if no information that can identify an individual is used and no linkage of data is planned, the research may be considered low risk.

Per the G-NatlStmt , researchers must prepare and follow an ethically defensible plan to manage the disclosure or non-disclosure of genomic information of potential importance for the health of participants or their relatives. An EC must approve the plan. Where researchers consider that the results of the research must be provided to participants, the project should be designed to include the mandatory return of results and this condition should be clear in any informational materials. In considering the appropriate form and scope of consent, as well as the most appropriate process for obtaining consent, researchers should consider:

• What information will be generated by the research
• What may be discovered by the research
• What will be deliberately excluded from the scope of the research
• Which, if any, of the findings of the research will be communicated to participants and, if so, how
• What the health implications are of the information for participants and their relatives
• Whether there are any other implications for participants and their families by being given this information
• The potential for the information generated by or used in the research to result in participants being re-identified
• Whether information generated by the research will be shared with other research groups
• Potential future use of information and biospecimens, including commercial applications

The G-NatlStmt further notes that consent specific to the research may not be required, or a waiver of the requirement for consent may be considered by an EC, if:

• The data or information to be accessed was previously collected and either aggregated or had identifiers removed
• Prior consent for the use of the data or information was provided under the scope of a research program that encompasses the proposed research project
• Prior consent for the use of the data or information was provided in the clinical context for research that encompasses the proposed research project
• Unspecified consent has been provided

In addition, researchers should consider how genomic research data or information will be stored in the event it is needed for future analysis/testing and disclosure to participants.

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Clinical Research Organization in US & India

Welcome to prorelix research cro, your drug development arm.

ProRelix Research is a Clinical Research Organization (CRO) with offices in the USA and India along with site networks in Australia, Thailand, Africa, and Europe supporting the clinical development of innovative new healthcare inventions and innovations to improve the health of patients. Every project is equally important to us. We first listen to you and strategize, aiming to a long-term partnership. We understand each project is unique on its own, and conscious clinical development, where efficiency is utmost and accuracy is supreme, is valuable and demanding to long-term success.

We provide services to help pharmaceutical, medical device, biopharmaceutical and nutraceutical/ herbal companies to transform scientific discoveries into new treatments. From clinical trial services, clinical data management services, pharmacovigilance services, medical writing services, drug regulatory affairs services, decentralized clinical trial services to leveraging real world insights, our therapeutic, technical, & operational ability is underpinned by a great conviction in what we do.

ProRelix Research has a global network of distinguished scientific leaders who are experts in a diverse range of therapeutic areas. We specialize in chronic diseases clinical trial services including oncology, respiratory, ophthalmology, endocrinology, immunology, dermatology, etc. Our reputation in clinical research services differentiates us from conventional clinical research organizations (CRO). We leverage our scientific leadership to establish and maintain the engagement of unique investigator networks for clinical research services.

Our Portfolio

Clinical trials play a pivotal role in the approval of new drugs as they most accurately reflect the effect of the drug in the human body. Since drug development is a costly and laborious process with the clinical trial phase...

Medical devices are an integral part of our lives from a simple thermometer to a life-saving pacemaker. Devising medical device clinical studies is complex and requires knowledge and experience-our experts at ProRelix Research can help you design studies depending upon...

The use of software to inform healthcare decisions is ubiquitous and is being utilized by patients, clinicians, and healthcare providers. Proper understanding, planning, and design of SaMD is essential for approval. ProRelix Research provides customized solutions and helps you adapt...

The success of a generic drug or biosimilar often hinges on the results of bioequivalence studies making it essential to partner with an experienced and reliable CRO to design and conduct bioequivalence studies. ProRelix Research offers full range service for...

ProRelix Research offers customized, end-to-end services for clinical trials of a broad range of biological products to help bring both innovator biologics and biosimilars to the market in a timely and cost-effective manner. We ensure compliance with regulatory requirements in...

The exponential growth in the natural product and dietary supplements field requires clinical trials to support safety and efficacy. ProRelix Research lends support at every step of your clinical trial journey to help you carve a niche in the dietary...

Diagnosis of diseases by clinicians using suitable tests guides treatment decisions and is necessary for improving and prolonging the health and well-being of patients. ProRelix Research partners with you to provide clinical trial support and ensure your device meets regulatory,...

ProRelix Research provides tailored end-to-end management of clinical trials keeping cost and patient safety at the forefront. We help you navigate the complex path of clinical trials by offering study support from patient recruitment to statistical interpretation to help you...

At ProRelix Research we understand that realization of the full potential of the emerging field of personalized medicine is dependent on the design and execution of clinical trials. We can help you circumvent the unique challenges associated with conducting precision...

ProRelix Research understands the utmost importance of protecting patient safety from clinical trials to real-world use of a new drug, biological or medical device. We help you develop appropriate pharmacovigilance plans and adverse event reporting systems in compliance with US...

Our experts at ProRelix research provide customized and comprehensive pharmacovigilance and safety monitoring programs in accordance with European Union (EU) regulations with an emphasis on patient well-being from research and development to post-market authorisation.

Patient safety and well-being lie at the heart of all our pharmacovigilance operations at ProRelix Research. We are with you every step of the way-from development of a pharmacovigilance system to regular reporting of safety and adverse events to regulatory...

How ProRelix Research can help you?

The successful execution and completion of a clinical trial are determined by several interconnected cross-functional expertise teams, including Medical Writing, Regulatory Affairs, Clinical Project Management, Clinical Data Management, Site Management, and Patient Recruitment,  Faster Ethics Committee Approval,  Pharmacovigilance, and much more.

A Quality driven Global Clinical Research Organization (CRO) that can truly understand your needs and help you to achieve your goals by minimizing the complexity across functional teams.  We at ProRelix Research strive to bring forth the best clinical research services managed by therapeutically sound experts and professionals who are having over a decade of international regulatory experience in conducting complex clinical trials into simple ones.

Also, our extensive knowledge, quality work, and global recognition make us an ideal choice for the rising demand for conducting holistic clinical trials which include New/ Repurposed  Pharmaceutical Products, Biological, Herbal, Nutraceutical, In Vitro Diagnostic Devices, Therapeutic Medical Devices, and more.

We are dedicated to follow the best ethical and clinical practices when conducting clinical studies while keeping the safety of all of our participant at core. Our motto is to provide our clients with prompt clinical study management, reliable clinical data with integrity, and ethical conduction of the clinical trials. The uniqueness of our services and functionality is that we not only design the ideal mechanism for better functionality of your trials but we also provide you a lending hand in all those processes and take you through them from the start till the end to reach your goal.

Our service portfolio includes Clinical Trial Project management, Phase 1 to 4 Clinical Trials, Drug Regulatory Affairs, Medical Writing, Clinical Data Management, Pharmacovigilance, Clinical Operations, etc . We are open to clients from all over the world and have a strong presence in USA and India and strategic partners in Europe, Australia. Let’s commit ourselves to better healthcare systems all around the world by ethical, prompt, and reliable clinical research studies!

Our  Highlights

• Clinical Research Organization with Global Services Capability in USA, India, Europe, and Australia
• Phase 1, 2, 3, and 4 clinical trial services for (i) Pharmaceutical (ii) Medical Device (iii) Herbal/ Neutraceutical
• Organized Structure and Reputation
• Experienced and  Best Service Portfolio
• Adaptability and Flexibility with Sponsor/Study Requirements
• Quality Assurance and Transparency

CRO Services

Clinical research services.

Our clinical research service focuses on the Quality, Ethics, and Well-being of the clinical trial subject… Read More

Data Management & Statistics Services

At ProRelix Research we are a team of experienced people who are well aware… Read More

Medical Writing Services

ProRelix Research’s medical writing service capabilities range from Clinical Research, Regulatory… Read More

Regulatory Affairs Services

ProRelix Research’s Regulatory Affairs services provide expert support in drug development programs. Read More

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We are very happy to have found Prorelix Research, during our relationship, ProRelix Research has delivered best services for our medical device study project..

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Ranking the top ten clinical research organisations in the world, top ten clinical research organisations.

Clinical research organisations support pharmaceutical companies during the research and development (R&D) phase by providing a way for some of the necessary stages in the clinical trial process to be outsourced.

Clinical research organisations play a central role in the pharma industry’s R&D efforts, as reflected in the size of the pharma outsourcing market, which reached a value of $36.7bn in 2017. Grand View Research has projected that he market’s value will top $51bn by 2024.

The continuing growth of the clinical research market and the number of related organisations begs the question, what are the largest global clinical research organisations?

Igea Hub, a pharmaceutical blog created by Novartis Oncology’s global medical director Luca Dezzani, has listed the top ten clinical research organisations worldwide for 2018. The list contains a mixture of publicly listed and privately held organisations, and only two of the top ten are not based in the US; ICON is based in Ireland and Wuxi Apptec is Chinese.

The ranking is based on a system that tracks revenue based on the company’s financial reports, annual revenue growth between 2016 and 2017, net income, expenses ratios, revenue per employee and scope of service portfolio. Each of these components is weighted, with revenue being the most important and composing 70% of the score, and the final ranking aims to represent the financial health, competitive advantage and activity status of the clinical research organisations listed.

Igea Hub’s top ten list is consistent with others compiled by pharma industry publications and websites, such as Pharma IQ.

Top ten clinical research organisations in 2017

Laboratory corporation of america holdings.

Laboratory Corporation of America was ranked at number one in Igea Hub's list of the top ten clinical research organisations with $10.44bn in revenue in 2017, of which 12.14% was income. The company has 31 units in its service portfolio.

Laboratory Corporation of America is composed of two business segments: LabCorp Diagnostics and Covance Drug Development. Covance is the portion that focuses on clinical research; it provides services to help with drug development throughout the clinical research process from early-stage research to post-regulatory approval. Covance claims to have worked on all of the 50 best-selling drugs on the market using its range of clinical and commercialisation services.

One recent example of Covance’s work in the clinical research space is working with the Chinese Food and Drug Administration (CFDA) on behalf of an Indian pharma company developing a new combination therapy for complicated Urinary Tract Infection (cUTI). Covance’s role included creating a regulatory strategy and facilitating interactions between the CFDA and the pharma company.

US-based, publicly listed IQVIA was created out of a merger between Quintiles and IMS Health in 2016. Its revenues for 2017 totalled $9.74bn with 13.44% representing income and it has 92 units in its service portfolio. Under the name Quintiles IMS, IQVIA was ranked number one in Igea Hub’s 2017 list of the top ten clinical research organisations, while LabCorp was ranked second.

These figures are consistent with the second quarter (Q2) 2018 results IQVIA reported in July; $2.567bn in revenue, an increase of 9% or 7.7% at constant currency.

IQVIA focuses on leveraging its IQVIA Core platform to help pharma companies and other medical bodies to innovate and maximise opportunities. In addition to clinical development, the company has also developed analytics and technology solutions to help the medical industry to commercialise products and better engage with customers.

Syneos Health

Created through the merger of INC Research and inVentiv Health, Syneos Heath is also based in the US and provides biopharmaceutical services in three areas: clinical development, commercialisation and consulting.

Syneos Health’s revenue for 2017 was $2.67bn with 91.1% spent on expenses and 42 services in its portfolio. The company’s revenue appears to be increasing in 2018 with $2.13bn for the first half of the year.

Within its clinical development segment, in addition to providing support to companies throughout each phase of the clinical research process, Syneos is also a functional service provider covering areas, including biostatistics, pharmacovigilance and patient recruitment.

Parexel International Corporation

Ranked at number four on Igea Hub’s list with a 2017 revenue of $2.44bn, Paraxel International is headquartered in Massachusetts, US and has been privately owned by Pamplona Capital Management since 2017. It partners with drug manufacturers and medical device companies throughout the product development and commercialisation process. 95% of its revenues in 2017 were dedicated to expenditure and its service portfolio has 79 units.

Parexel has fallen one place from its ranking from 2017 with revenues of $2.43bn for 2016 and 79 units in the portfolio.

The company initially focused on supporting German and Japanese pharmaceutical firms, but has expanded and now has clients in more than 100 countries worldwide.

Parexel partnered with data-focused marketing technology company Datavant earlier in September this year. The aim of the partnership is to enhance its clinical study design and capacity by allowing the linking of healthcare data from different sources.

PRA Health Sciences

US-based PRA Health Sciences was acquired by Kohlberg Kravis Roberts and made public in 2014. Its 2017 revenue was $2.26bn, a 24.73% increase from 2016, which earned it a rise of one place in Igea Hub’s ranking.

Revenue growth seems to be continuing with the company reporting $722.8m in Q2 2018, which represents 34.2% growth on a constant currency basis from Q2 2017.

The company primarily focuses on offering operational and therapeutic expertise to its clients through integrated systems, as well as supplying local expertise in specific regions via its 80 global offices. PRA works in both early and late-stage clinical trial processes, as well as the fields of consultancy, technology, strategy and bio-analytics.

Pharmaceutical Product Development

Privately-held, North Carolina-based Pharmaceutical Product Development (PPD) had $1.90bn in revenue for 2017 and a service portfolio of 44 units.

The company focuses on three areas: drug development, laboratory and lifecycle management services. It has clients in a range of areas in addition to pharmaceutical companies, including medical device manufacturers, academic organisations and government groups.

In June this year, PPD launched a new patient enrolment model called PatientAdvantage, which it claims reduces the time and cost of conducting clinical trials by conducting data-driven research to identify eligible patients.

The PatientAdvantage system has been employed in three Phase III studies conducted for The Medicines Company, which were part of the ORION project.

Charles River Laboratories

Ranked seventh is Charles River Laboratories, a 71-year-old publicly-listed, US company, which claims to have worked on 80% of the drugs approved by the FDA in 2017. Its revenue for 2017 totalled $1.86bn, representing a 10.47% increase on 2016.

Charles River was ranked first in Igea Hub’s 2016 list, falling to ninth in 2017.

The company’s capabilities span the entire drug R&D process from basic research to pre-clinical testing to manufacturing and commercialisation within two major services: Good Laboratory Practice (GLP) and non-GLP. Charles River recently purchased Thermo Scientific’s Lab Vision Autostainer 720 to enhance its immunohistochemistry automation capacities, thus reducing the time it takes to run slides and the risk of batch variation.

Falling one rank from 2017 to number eight is Icon plc. It is based in Ireland and generated $1.76bn in revenue in 2017, compared to $1.67bn in 2016, which represents an increase of approximately 5%.

The company’s revenue growth continues into 2018; it reported a10% year-on-year revenue increase of $473.9m in Q2.

Icon offers a range of consulting, development and commercialisation services in 37 countries, but it has a specific focus on the Asia-Pacific and Latin America regions. It has established many partnerships with pharmaceutical industry companies and healthcare organisations; a recent example is electronic health record company Practice Fusion to improve Icon’s use of patient data during the clinical trial process.

WuXi Apptec

Chinese privately firm WuXi Apptec focuses on reducing the discovery and development time for pharmaceutical and medical device products.

The company recorded a revenue of $1.01bn in 2017, and dropped one place from the 2017 ranking; in 2016 its revenue was estimated to be $919.9m. It had a service portfolio of five in both 2016 and 2017.

WuXi’s portfolio includes small molecules, biologics, cell and gene therapy and genomics and it provides support to biotechnology and pharmaceutical companies throughout the R&D process and into the commercialisation phase.

Earlier in September this year, WuXi’s partner, Shanghai-based Hutchison MediPharma, received approval for Elunate for metastatic colorectal cancer in China. WuXi’s STA subsiary supported the market launch of this drug through process optimisation and validation of Elunate’s active ingredient, as well as aiding with the regulatory submission process.

Medpace Holdings

US-based, publicly listed Medpace Holdings was ranked tenth in Igea Hub’s list of the top ten clinical research organisations in the world with a total 2017 revenue of $436m.

Medpace was not listed on the 2017 list, but is growing quickly with its share value rising more than 34% in the past quarter and 86% in the past year.

The company offers full-service clinical trial outsourcing through its medical, regulatory and operational teams.

"Ranking the top ten clinical research organisations in the world" was originally created and published by Pharmaceutical Technology , a GlobalData owned brand.

The information on this site has been included in good faith for general informational purposes only. It is not intended to amount to advice on which you should rely, and we give no representation, warranty or guarantee, whether express or implied as to its accuracy or completeness. You must obtain professional or specialist advice before taking, or refraining from, any action on the basis of the content on our site.