research case report forms

Case Report Form: Types Uses & Template Examples

Case report forms are one of the most important data instruments used for clinical researches and medical examinations. When conducting clinical trials, the researcher needs to record even the smallest of observations as they happen. A case report form is designed for this purpose.

In a case report form, you can track the unique changes of each research subject as the clinical trial progresses. This article will discuss different case report forms and show you how to create this form from scratch using Formplus.

What is a Case Report Form?

A case report form is an essential tool for clinical research, although it has been extended for use in other areas of medicine. Primarily, it is a record of all symptoms, signs, diagnosis, treatment, follow-up, observations, changes, and other important information from each research subject during clinical trials. The data gathered via case report forms (CRFs) are analyzed to arrive at the research results and draw valid conclusions.

It is one of the most effective ways to systematically collect and store all the information from research for use. For example, during clinical trials to test the efficacy of a drug, you need to collect data at every stage of the process to answer all your research questions.

In a broader sense, a case study is a questionnaire used for collecting data from patients in the course of any medical procedure, including diagnoses and treatments. It provides valid information that makes up the patient’s medical history which can be used for medical research.

Importance of a Case Report Form

It provides valid information for hypothesis-testing during clinical research.
A case report form captures standardized clinical data at every stage of the research process. This data is analyzed to arrive at research outcomes.
Case report forms play an essential part in medical research breakthroughs. By storing unique data from each research subject, case report forms create a large pool of verifiable medical research information.
It improves problem-based medical education.
Data from case report forms make up a large chunk of peer-reviewed journals in medical research.
Medical researchers leverage existing data from different case report forms to advance systematic investigations in specific fields and sub-fields.
Data from case report forms have helped us develop treatments and vaccines for different diseases, viruses, and infections.

Types of Case Report Form

Paper case report form.

A paper case report form is the traditional method of collecting data during clinical trials. It is the use of paper questionnaires and paper-based systems to gather detailed information from research subjects as per the study protocol. This data is extracted, organized and analyzed to arrive at valid research outcomes.

Advantages of Paper Case Report Forms

It is relatively easier to create and implement paper case report forms.
It allows you to collect research data in remote areas without electricity supply and internet access.

Disadvantages of Paper Case Report Forms

Data loss due to theft and exposure to natural elements like fire outbreaks and floods.
It is difficult to organize and analyze large volumes of data.
When dealing with large volumes of information, it can be challenging to sort the data sets.
It is time-consuming and prone to errors.

Electronic Case Report Form

An electronic case report form is an online questionnaire used for data collection in medical studies and clinical trials. This method of data collection in medical research was introduced in the late 1990s following the shortcomings of paper forms. Electronic case report forms support more accurate data collection and faster data processing.

Advantages of Electronic Case Report Forms

It allows for faster data collection; especially when you are dealing with large volumes of data.
It reduces data losses, errors and costs.
ECRFs allow you to share data remotely among different stakeholders in the research process.
It facilitates rapid data capture and data management.
Easy and transparent access to research data at all times.

Disadvantage of Electronic Case Report Forms

High costs depending on the complexity of the electronic case report form.

Case Report Form Template Examples

Case Report Form

Use this case report form from Formplus to collect specific data from patients as part of the standard medical research procedure. With this survey, you can gather all the important information you need from the patients at once, and then go ahead with a proper diagnosis.

Health Care Proxy Form

The Formplus health care proxy form serves as a legal document for individuals who want to empower others to make decisions for them when they are sick or unavailable. With this form, individuals can formally select their health care providers to act on their behalf when the need arises. You can also edit this proxy form to suit unique needs in the form builder.

Medical Information Form

With the Formplus medical information form, patients can easily keep track of their health status by having all the information they need in one place. This form collects relevant information about the individual’s medical history, bio-data and doctor’s contact information in case of emergency.

Clinical Report Form

Are you conducting any type of clinical research? This form will help you to seamlessly gather and analyze all the data you need for your systematic investigation. While this is a template, you can always edit it to suit your needs using the different features in our drag-and-drop form builder.

Physical Examination Report Form

As you conduct physical examination of your patient, you can put all the information you gather in a Formplus physical examination form. This form allows you to collect data like the gender, weight, blood pressure and height of the patient. Our physical examination form makes it easy to document the patient’s health history.

Self Report Form

To make it easier for patients to check for symptoms and monitor their health, you can edit this self-report form and embed it on your hospital’s website for easy access. With this form, health officials and medical practitioners can keep track of and monitor the health status of their patients and employees if the need arises.

Why Use Formplus to Create a Case Report Form?

A case report form can be administered as a paper form or an online form; that is, ECRF. Data collection platforms like Formplus allow you to create secure online CRFs with data validation and data export features. You can also generate reports from the data in the form analytics dashboard.

Collect Data Anywhere : Formplus allows you to collect research data in locations with poor or no internet connection using offline forms. The information filled into the case report form is automatically updated on our servers or your preferred cloud storage system once internet access is restored.
Collect Data on Mobile Devices: You don’t need to have a laptop to record responses on your Formplus form. All Formplus forms are mobile-friendly and allow you to fill in responses from your smartphone. This allows you to record data on the go as you conduct clinical trials.
Analyze Data Easily : In the form analytics dashboard, you can access important insights about your data and data collection process. You can automatically generate custom visual reports for your form data using the reports summary tool available in Formplus. With just a few clicks, this tool instantly displays selected form fields and form data as custom graphs and charts.
Add Multiple Form Fields : With more than 30 form fields, you can collect different types of information in your electronic case report form, seamlessly. You can add long text fields for open-ended questions and different types of scales and radio fields for closed-ended questions.
Export Data : Formplus allows you to export research data to other file formats including CSV, PDF and Google sheets. This makes it easier for you to collaborate with others and share data from your online case report form easily.
Teams and Collaboration: With teams and collaboration, you can easily keep all the members of your research team in sync as you work on forms, data, and responses. Formplus allows you to add important collaborators to your shared account so that everyone can have access to the clinical trials reports in real-time.

How to Create Electronic Case Report Forms With Formplus

1. Create a free Formplus account on www.formpl.us . Then log into your new account to view your dashboard.

2. Click on the “create new form” button to access the Formplus dashboard.

3. In the Formplus dashboard, you can add multiple fields to the online case report form. Drag and drop the fields you want from the builder’s fields section into your form.

4. Edit the form fields to include your question, options and other information. Here, you can also set the fields as required or read-only.

5. Save all the changes you’ve made to access the form customization section. Use the different features and options to tweak the look and feel of your case report form.

6. Copy the form link and share with respondents.

Conclusion

In this article, we have looked at different types and use-cases for case report forms. As a researcher, it is best to use electronic CRFs that reduce your risk of data losses and help you record information faster.

When you sign up for a Formplus account, you can access different case report form templates to help your research. From medical information surveys to health care proxy forms, you are sure to find a template that suits your research purpose. In the form builder, you can edit these templates to align them with your research goals.

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Basics of case report form designing in clinical research

Affiliations.

1 Global Medical Affairs, Dr. Reddy's Laboratories Ltd., Hyderabad, India.
2 Clinical Research, USV Limited, Mumbai, India.
PMID: 25276625
PMCID: PMC4170533
DOI: 10.4103/2229-3485.140555

Case report form (CRF) is a specialized document in clinical research. It should be study protocol driven, robust in content and have material to collect the study specific data. Though paper CRFs are still used largely, use of electronic CRFs (eCRFS) are gaining popularity due to the advantages they offer such as improved data quality, online discrepancy management and faster database lock etc. Main objectives behind CRF development are preserving and maintaining quality and integrity of data. CRF design should be standardized to address the needs of all users such as investigator, site coordinator, study monitor, data entry personnel, medical coder and statistician. Data should be organized in a format that facilitates and simplifies data analysis. Collection of large amount of data will result in wasted resources in collecting and processing it and in many circumstances, will not be utilized for analysis. Apart from that, standard guidelines should be followed while designing the CRF. CRF completion manual should be provided to the site personnel to promote accurate data entry by them. These measures will result in reduced query generations and improved data integrity. It is recommended to establish and maintain a library of templates of standard CRF modules as they are time saving and cost-effective. This article is an attempt to describe the methods of CRF designing in clinical research and discusses the challenges encountered in this process.

Keywords: Case report form; case report form design; completion guidelines; electronic case report form; standard templates.

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Conflict of interest statement

Conflict of Interest: None declared.

A sample case report form…

A sample case report form (CRF) page. An adverse event page of CRF…

Example of a poorly designed…

Example of a poorly designed case report form

Illustrating the missing indicator question

Coding on the case report…

Coding on the case report form module

Sample page of case report…

Sample page of case report form completion guideline

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Case Report Form (CRF) Binder/Electronic Case Report Form (eCRF)

According to ICH GCP EC 1.11, a case report form is a printed, optical, or electronic document designed to record all of the protocol required information to be reported on each trial subject. CRFs are designed by the sponsor or sponsor-investigator and maintained at the investigative site. Information documented on the CRF (or eCRF) must be supported by source documentation. At a minimum the CRF should record:

Inclusion/exclusion criteria and assessment as to whether the subject met them
Protocol-specific clinical laboratory testing (including EKGs, X-rays, eye exams, scans, etc.) documented by laboratory records
All AEs, SAEs, concomitant therapies, and/or inter-current illnesses
Assessment of severity of AEs, relationship to test article, and expectedness of the AE
Report of all dropouts and the reasons

One of the most essential tasks performed by the Clinical Research Coordinator (CRC) is completing and/or ensuring the completion of the subject’s CRF. Most sponsors will provide instructions or a guide for CRF completion. Handwriting must be legible and should be completed in black ink. All data points must be addressed and for fields that cannot be completed, “not available,” “not done” or “unknown” should be marked in accordance with the sponsor’s instructions. The CRC will ensure that all required data are collected and entered on the CRF as soon as possible after, if not during, the visit. All CRFs should be checked for completeness and legibility. The CRFs should be reviewed and signed by the investigator prior to submission. Only those physicians identified on the 1572 may sign CRFs. When making a correction on a CRF, a single line should be drawn through the incorrect entry and the correct data should be entered above or next to the incorrect entry. The correction should be dated and initialed. White-out or eraser should never be used to correct an error. Blanks identified prior to the investigator’s review and sign-off on the CRF can simply be completed. Those identified after sign-off must be dated and initialed.

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A Case Report Form (CRF) is a critical component of clinical trials and research studies. It's a structured document used by researchers and data managers to collect and record data on each study participant. The design and development of CRFs play a crucial role in ensuring accurate and consistent data collection.

Here's an in-depth look at CRF design and development:

1. Purpose of CRF:

- CRFs serve as standardized tools to collect specific data points according to the study protocol.

- They capture demographic information, medical history, treatment details, adverse events, and other relevant variables.

2. CRF Design Process:

- Protocol Review: Understand the study protocol, research objectives, and endpoints to determine the data points that need to be collected.

- Variable Identification: Identify the variables required for analysis, such as primary and secondary endpoints, safety assessments, and patient demographics.

- Data Dictionary: Create a comprehensive data dictionary that defines each variable, its format, and allowable values.

- CRF Structure: Organize the CRF logically, grouping related data fields together and ensuring a user-friendly layout.

3. Key Considerations in CRF Design:

- Clarity and Consistency: Use clear and concise language to minimize ambiguity and ensure consistent data collection across sites.

- Standardized Terminology: Incorporate standardized medical coding systems (e.g., MedDRA, ICD-10) to maintain consistency and facilitate data analysis.

- User-Friendly: Design CRFs that are intuitive and easy to navigate for data entry personnel.

- Validation Checks: Include built-in validation checks to prevent data entry errors, such as range checks and logic checks.

- Response Options: Provide predefined response options (e.g., checkboxes, radio buttons, drop-down lists) for categorical variables.

- Open-Ended Fields: Include open-ended fields for narrative descriptions, comments, and additional information.

4. CRF Development:

- Paper CRFs: Traditional paper CRFs involve printed forms that data entry personnel complete manually.

- Electronic CRFs (eCRFs): Modern trials often use electronic data capture (EDC) systems for digital data entry, allowing real-time validation and remote monitoring.

5. Quality Control:

- Pilot Testing: Test the CRFs on a small sample of participants or data entry personnel to identify any design flaws or ambiguities.

- Review and Approval: CRFs should undergo thorough review by investigators, clinicians, statisticians, and regulatory experts.

- Version Control: Maintain version control to track any revisions or updates to the CRFs.

6. CRF Training and Implementation:

- Provide training to data entry personnel on how to complete the CRFs accurately and efficiently.

- Ensure consistency in data collection practices across different sites and personnel.

7. Regulatory Compliance:

- CRF design should align with regulatory requirements and guidelines, ensuring data integrity and patient safety.

8. Continuous Improvement:

- Monitor the data collection process and identify opportunities for improvement based on feedback and data quality assessments.

Effective CRF design and development are essential for collecting reliable and high-quality data in clinical trials. A well-designed CRF enhances data accuracy, facilitates analysis, and contributes to the overall success of the study.

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Case Report Form

28. June 2024

Importance of Case Report Forms in Clinical Research

Regulatory compliance, designing a case report form, elements of a crf, electronic case report forms, role of the case report form in data management, data entry and cleaning, data validation and analysis.

The Case Report Form (CRF) is a pivotal tool in clinical research . It is a document used in clinical trials to collect data from each participating patient . The CRF serves as a record of each participant’s clinical and demographic information, which is critical to the trial’s success. This article will delve into the intricacies of the CRF, its importance, design, and the role it plays in clinical research.

The CRF is a structured, participant-specific document that captures information in a consistent manner. It is designed to collect the specific data needed to answer the research question or objectives of the clinical trial. The data collected on a CRF can include participant demographics, medical history, trial procedure data, outcomes, and adverse events. The data is then used for statistical analysis to determine the trial’s results.

The importance of CRFs in clinical research cannot be overstated. They are the primary tool for collecting and managing data in a clinical trial. Without a well-designed and properly filled CRF, the data collected may be incomplete, inaccurate, or unusable, jeopardizing the validity of the trial’s results.

CRFs also play a crucial role in ensuring the safety of trial participants. They record any adverse events or reactions experienced by participants, which can then be monitored and addressed. This information can also contribute to the overall understanding of the investigational product’s safety profile.

CRFs are also critical for ensuring regulatory compliance. Regulatory bodies such as the Food and Drug Administration (FDA) and the European Medicines Agency (EMA) require detailed documentation of clinical trials, including the data collected on CRFs. These bodies may review the CRFs during audits to ensure the trial is being conducted according to regulatory standards and guidelines.

Failure to maintain accurate and complete CRFs can result in regulatory sanctions, including the rejection of trial results. Therefore, the importance of a well-designed and properly managed CRF in clinical research cannot be overstated.

The design of the CRF is a critical step in the planning of a clinical trial. The CRF must be designed to collect the specific data needed to answer the research question or objectives of the trial. This requires a thorough understanding of the trial protocol, the investigational product, and the disease or condition being studied.

The design of the CRF should also take into account the needs of the various stakeholders involved in the trial, including the investigators, the data management team, the statistical team, and the regulatory bodies. The design should facilitate accurate and efficient data collection, minimize errors, and ensure data quality.

A well-designed CRF typically includes several key elements. These include participant demographics, medical history, trial procedure data, outcomes, and adverse events. Each of these elements should be clearly defined and structured to facilitate accurate and consistent data collection.

Participant demographics typically include information such as age, sex, race, and ethnicity. Medical history can include past and current medical conditions, medications, and surgeries. Trial procedure data can include information about the investigational product, dosing, and administration. Outcomes can include measures of efficacy, such as symptom improvement or disease progression. Adverse events can include any negative reactions or side effects experienced by the participant.

With the advancement of technology, many clinical trials now use electronic Case Report Forms (eCRFs). eCRFs offer several advantages over traditional paper-based CRFs, including improved data quality, real-time access to data, and streamlined data management processes.

eCRFs also offer enhanced security features, such as user access controls and audit trails, which can help ensure data integrity and regulatory compliance. However, the design and implementation of eCRFs require additional considerations, such as user training, system validation, and data privacy and security.

The CRF plays a central role in the data management process of a clinical trial. Once the data is collected on the CRF, it is typically entered into a database for storage, cleaning, and analysis. The quality of the data collected on the CRF directly impacts the quality of the data in the database and, ultimately, the validity of the trial’s results.

Data management involves several steps, including data entry, data cleaning, data validation, and data analysis. Each of these steps relies on the data collected on the CRF. Therefore, the accuracy and completeness of the CRF are critical to the success of the data management process.

Data entry is the process of transferring the data from the CRF into the database. This process can be prone to errors, such as transcription errors or data entry mistakes. Therefore, it is important to have procedures in place to ensure the accuracy of data entry.

Data cleaning is the process of checking the data in the database for errors or inconsistencies and correcting them. This process relies on the data collected on the CRF. If the CRF is inaccurate or incomplete, the data cleaning process may not be able to correct all errors or inconsistencies, compromising the quality of the data.

Data validation is the process of checking the data in the database against the original data collected on the CRF. This process ensures that the data in the database accurately reflects the data collected on the CRF. If the CRF is inaccurate or incomplete, the data validation process may identify discrepancies that cannot be resolved, compromising the validity of the data.

Data analysis is the process of analyzing the data in the database to answer the research question or objectives of the trial. The quality of the data analysis relies on the quality of the data in the database, which in turn relies on the quality of the data collected on the CRF. Therefore, the accuracy and completeness of the CRF are critical to the success of the data analysis process.

The Case Report Form is a critical tool in clinical research. It is the primary means of collecting and managing data in a clinical trial. The design and management of the CRF can significantly impact the quality of the data collected, the validity of the trial’s results, and the safety of the trial participants.

Therefore, a well-designed and properly managed CRF is essential for the success of a clinical trial. It requires a thorough understanding of the trial protocol, the investigational product, and the disease or condition being studied. It also requires careful planning, meticulous attention to detail , and rigorous quality control processes.

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How to Prepare Case Report Forms

Planning how and what data to collect in an investigator initiated trial (IIT) is one of the most challenging tasks for researchers. On the one hand, there needs to be sufficient data collected to support and test the study’s hypotheses. On the other hand, the over-collection of data results in wasted resources. The case report form (CRF), which is used to collect patient data for analysis, therefore needs to be carefully designed with great attention to details. This article will highlight some useful tips for you to keep in mind when designing your CRF.

Paper or Electronic Formats

There are two types of CRFs, the traditional paper form and the newer electronic format (eCRF). For small clinical studies and IITs, the paper CRF may be a suitable option because it can be easily implemented. It does not require upfront investment costs for the technology and training that is required for an eCRF. The drawback of paper CRFs, however, is that it is tedious to design and execute, as well as highly prone to errors in data entry and data transfer. The use of eCRFs overcomes a lot of disadvantages just mentioned and is the preferred method globally for CRFs of large clinical trials. They are much less time-consuming and more friendly to use for the clinical investigators. Additionally, the use of eCRFs makes it easy to collect and harmonize data from multicentre studies. Moreover, the use of eCRFs also facilitates the approval process by regulatory bodies. The downside, of course, is there are costs associated with implementing an eCRF system. So, the choice between paper or electronic formats entirely depends on your preference and budget.

Design Tips

A well-drafted CRF will ensure the integrity and quality of the data collected. In contrast, a poorly designed CRF form could prove costly for the study as it will lead to incomplete and inaccurate data collection—and in some cases not collecting essential data at all. We’ve summarized some of the essential tips to help you improve your CRF design:

Avoid duplication of data and unwanted details
Prevent page clutter by adding white spaces wherever possible
Remove any potential ambiguity in language or data entry
Provide clear instructions, questions, and prompts
Use bold and italics to highlight instructions
Provide adequate instructions as to when to skip questions or sections
Ensure that the document is formatted the same throughout with proper font style and size
Use visual cues such as box outlines to direct the place and format of data to be entered
Use checkboxes instead of circling answers to avoid confusion
Reduce the amount of free text response as these are hard to interpret
For numeric entries, signify the number of decimal places and the units
Ensure that date formatting and page numbers are consistent throughout the document
Wherever possible, use pre-determined answers (yes/no, mild/moderate/severe)
Avoid calculations on the CRF
Ensure that the subject ID and CRF version appears on every page for keeping track of missing data

The example below on the left shows a poorly designed CRF. Notice how it does not include a version number in the footer or instructions on how to complete it. Furthermore, instead of using checkboxes with pre-determined answers, it uses free-text boxes that are hard to interpret and prone to errors. There are also no instructions on how to fill out the visit date or date of birth, so the date formats could vary between investigators. The example on the right shows a significantly better version of the CRF form.

There is often a lot of overlap in data requirements across clinical studies, so it’s a good idea to develop a standard CRF that can be customized as needed. Using the same standard structure will also reduce the amount of training required to fill out future CRFs. Some examples of CRF templates that can be reused across studies include demographics, medical history, physical examination, and adverse tracking list. Below you will find links to CRF templates that can help you get started:

National Center for Complementary Integrative Health CRF templates ( https://www.nccih.nih.gov/grants/toolbox )
University of Wisconsin-Madison CRF templates ( https://ictr.wisc.edu/clinical-research-toolkit-2/case-report-form-templates/ )

In addition to a CRF, you will also need to draft a CRF completion guideline. This document will provide step by step instructions to help investigators complete the CRF. The language should be clear and concise and easy to follow.

The objective of designing CRFs is to ensure accurate and complete data collection and ease-of-use for the investigators. Keep in mind that design is a process, and over time, after multiple iterations, your CRF will gradually improve and become more robust. As always, we recommend you ask your investigators for feedback on the CRF’s design and how to improve it. For more help on CRFs, IITs, and other clinical study-related topics, please contact Sengi.

1. Bellary S, Krishnankutty B, Latha MS. Basics of Case Report Form Designing in Clinical Research. Perspect Clin Res 2014;5:159-66.

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Clinical research tools: what is a crf (case report form), what is a crf in clinical trials.

In medical terms, CRF stands for case report form. A CRF is a document that is used to compile all protocol-related information for each participant in a clinical trial. This data can include everything from participants’ personal information to study visit results to treatment outcomes and side effects experienced. CRFs are integral for standardizing data collection and for sharing data across sites and between investigators and sponsors.

What is the purpose of a CRF in clinical research?

The primary purpose of the CRF is standardized data collection and recording, to ensure that complete information is collected for all participants in the same format. A CRF allows the investigators and sponsors to hold all important details about the participants in a clinical trial in one place, which is important for regulatory affairs as well as drawing conclusions from trial data.

The clinical trial sponsor/investigator is responsible for creating a study-specific CRF template that appropriately captures all data involved in or required by the study protocol. They will prepare CRF completion guidelines, and ensure that the staff at each study site is properly trained with respect to filling in this data. The sponsor/investigator is also responsible for managing, reviewing, and validating CRFs. Designing a good CRF is a complex and nuanced task, and has been called an art ; it requires significant planning, attention to detail, and consideration of the study protocol and various stakeholders.

What does a case report form consist of?

One CRF is created for each participant, and will contain all information that is collected and intended to be analyzed, as per the unique study protocol. Information that will not be analyzed should be excluded from the CRF. The CRF should be designed in such a way that data is entered consistently and completely for all participants; it will thus be fairly detailed in terms of how data should be entered. Although different studies will require different data fields in CRFs, parts of well-designed CRFs can often be used by sponsors across various trials. CRFs can vary in length, depending on the complexity and length of the trial.

A CRF form includes three major parts : a header, a safety module, and an efficacy module. The header specifies important identification details such as site, participant ID, and study numbers. The safety module covers principal safety analysis criteria outlined in the protocol, including fatalities, drop-outs, demographic data, medical histories, eligibility validation, adverse events, and physical examination records. The efficacy module concerns endpoints and additional tests that are used to assess treatment efficacy in the study protocol.

Before the site personnel transfers CRF data to the sponsor for reporting and analysis, it is often de-identified to keep the patient's identity anonymous. Each patient is assigned a study number, and certain personal information, attributes, or even the treatment group may be anonymized in order to avoid potential bias in the interpretation of results.

New developments in CRFs

There are challenges associated with manual data entry and standardization that commonly lead to issues with data integrity, completeness, and organization in paper-format CRFs if not properly controlled. In most clinical trials, a monitor is tasked with CRF data validation to check for errors and ensure accuracy and consistency of the data. This is a time-consuming task.

eCRF: Electronic case report forms

As technology and digitalization continue to revolutionize clinical research processes, many clinical researchers have switched from paper CRFs to electronic CRFs, or eCRFs. An eCRF contains the same data as a traditional CRF, but is filled out and stored electronically. This can help address manual data entry errors and streamline the data validation process. However, there is an ongoing debate over whether paper CRFs or eCRFs are better. Let's look at the main advantages and disadvantages of eCRFs relative to paper-format CRFs:

Faster: Filling out an eCRF may be quicker and easier, especially as some aspects can be automated in specialized eCRF software solutions
Reduced error: eCRFs can be created in such a way so as to minimize the possibility of data entry errors (field validation)
Built-in validity checks: Built-in validation features in some eCRF solutions allows for rapid identification of missing data, inconsistencies, or unexpected values, which can facilitate data validation tasks and improve data quality

Disadvantages

Complexity of setup and installation: It will likely be necessary to utilize third-party software or design a program and/or workflow to manage the eCRFs. This will require an adjustment away from traditional methods and a learning curve for staff using the system. The system will need to be installed at all trial sites involved in a study as well as centrally for real-time data capabilities and organization.

Initial investment costs: In relation to the above point, there may be a one-off cost or monthly payment for the eCRF management software. Nonetheless, the costs are likely to be offset by the improved efficiency and data consistency.

Artificial intelligence and machine learning in CRFs

Artificial intelligence and machine learning are being leveraged to transform how CRFs are filled out in clinical trials. These technologies can be involved in automation techniques to enable batch data entry of critical patient information into eCRFs quickly and automatically.

Tips for designing error-proof CRFs

As mentioned, the CRF needs to be designed carefully in order to capture all essential data for the study and maximize data consistency and validity. Here are a few expert tips for designing high-quality case report forms:

Be explicit: Provide instructions that are as detailed as possible to ensure data consistency
Mark instructions clearly: Leverage italicized, bold, or otherwise stand-out format
Work from the study protocol: Follow a hypothetical patient through the entire study process to ensure that all data expected from the protocol is provided for in the form
Provide explicitly clear instructions regarding ‘skip patterns’ that are easily visible and logical to follow
Include clearly defined and separate lines, fields, or boxes for each expected answer/entry.
Reduce free text fields - include as much guidance as possible for data input. E.g.: Avoid: Date of birth: __________ Better: Date of birth: dd/mm/yyyy
For paper CFRs, utilize multi-sheet NCR forms to ensure identical copies of the CRF
Use consistent formatting (font, style, size) throughout the case report form - i.e., one style for instructions, another style for titles/headings, and another yet for example data
In eCRF tools or electronic databases, activate built-in validity checks and flags for improperly entered/missing data

Conclusions

High-quality CRFs are key to successful clinical trial patient data management. Careful planning and design of the CRF template is important for optimizing data consistency, validity, and accuracy, which in turn facilitates data sharing and regulatory affairs, optimizes data organization, and streamlines analysis of study data and results. eCRFs are increasingly adopted in clinical trials as they can help reduce errors and minimize manual work while maximizing data consistency and its associated benefits.

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Peer review
Victoria Stokes , foundation year 2 doctor, trauma and orthopaedics, Basildon Hospital ,
Caroline Fertleman , paediatrics consultant, The Whittington Hospital NHS Trust
victoria.stokes1{at}nhs.net

Victoria Stokes and Caroline Fertleman explain how to turn an interesting case or unusual presentation into an educational report

It is common practice in medicine that when we come across an interesting case with an unusual presentation or a surprise twist, we must tell the rest of the medical world. This is how we continue our lifelong learning and aid faster diagnosis and treatment for patients.

It usually falls to the junior to write up the case, so here are a few simple tips to get you started.

First steps

Begin by sitting down with your medical team to discuss the interesting aspects of the case and the learning points to highlight. Ideally, a registrar or middle grade will mentor you and give you guidance. Another junior doctor or medical student may also be keen to be involved. Allocate jobs to split the workload, set a deadline and work timeframe, and discuss the order in which the authors will be listed. All listed authors should contribute substantially, with the person doing most of the work put first and the guarantor (usually the most senior team member) at the end.

Getting consent

Gain permission and written consent to write up the case from the patient or parents, if your patient is a child, and keep a copy because you will need it later for submission to journals.

Information gathering

Gather all the information from the medical notes and the hospital’s electronic systems, including copies of blood results and imaging, as medical notes often disappear when the patient is discharged and are notoriously difficult to find again. Remember to anonymise the data according to your local hospital policy.

Write up the case emphasising the interesting points of the presentation, investigations leading to diagnosis, and management of the disease/pathology. Get input on the case from all members of the team, highlighting their involvement. Also include the prognosis of the patient, if known, as the reader will want to know the outcome.

Coming up with a title

Discuss a title with your supervisor and other members of the team, as this provides the focus for your article. The title should be concise and interesting but should also enable people to find it in medical literature search engines. Also think about how you will present your case study—for example, a poster presentation or scientific paper—and consider potential journals or conferences, as you may need to write in a particular style or format.

Background research

Research the disease/pathology that is the focus of your article and write a background paragraph or two, highlighting the relevance of your case report in relation to this. If you are struggling, seek the opinion of a specialist who may know of relevant articles or texts. Another good resource is your hospital library, where staff are often more than happy to help with literature searches.

How your case is different

Move on to explore how the case presented differently to the admitting team. Alternatively, if your report is focused on management, explore the difficulties the team came across and alternative options for treatment.

Finish by explaining why your case report adds to the medical literature and highlight any learning points.

Writing an abstract

The abstract should be no longer than 100-200 words and should highlight all your key points concisely. This can be harder than writing the full article and needs special care as it will be used to judge whether your case is accepted for presentation or publication.

Discuss with your supervisor or team about options for presenting or publishing your case report. At the very least, you should present your article locally within a departmental or team meeting or at a hospital grand round. Well done!

Competing interests: We have read and understood BMJ’s policy on declaration of interests and declare that we have no competing interests.

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The Essential Guide to eCRF (Electronic Case Report Form) for Medical Devices

In clinical investigations, investigators traditionally use paper Case Report Forms (CRFs) to collect data from participating patients, including patient characteristics and demographic data, adverse events , and the results of experimental treatments.

When a study is completed, paper CRF forms are boxed and shipped from the study site to the study sponsor, where the data will be cleaned, prepared, transformed, and transcribed into a computer database prior to analysis.

Paper-based CRFs have been standard practice in clinical investigation for decades, but medical device companies in recent years are increasingly choosing to digitize the data collection process with a new kind of CRF: electronic Case Report Form (eCRF) .

In this essential guide, we’ll cover all the basics about eCRFs in clinical trials for medical device companies. You’ll learn what they are, how to design an effective eCRF, and the benefits of choosing eCRF instead of paper-based CRF for your next study.

FREE RESOURCE: Click here to download your free PDF copy of 7 best practices for how to design an electronic case report form.

What is an eCRF?

An eCRF (electronic case report form) is the digital version of a paper-based case report form - it’s a digital questionnaire completed by researchers to collect and report data from participating patients in a clinical trial.

While paper CRFs require physical storage, security, and transportation, collecting clinical data in a digital format with an eCRF means that the data can be securely uploaded to the cloud and shared with other stakeholders in near-real time.

As a result, switching from paper-based data collection to eCRF can help medical device companies execute clinical studies in less time, with less risk, and at a lower cost.

Is eCRF the same as Electronic Data Capture (EDC)?

eCRF and Electronic Data Capture (EDC) are semantically similar terms that relate to data collection in clinical studies, which explains why certain sources are using these terms interchangeably.

Still, eCRF and EDC are not the same thing and clinical study managers should understand the difference between them.

We’ve already defined eCRFs above as the digital version of a case report form that researchers will complete during a clinical trial.

An EDC system is a software solution, purpose-built to enable data collection as part of a clinical study. EDC systems allow sponsors to design eCRFs and provide a graphical user interface where researchers can complete and submit eCRFs as part of a clinical study.

EDC systems can also enable other forms of data collection, including automatic transmission from electronic health records (EHR) and connected medical devices.

Plus, EDC systems enable software-based controls on data entry and data access that help ensure the accuracy, authenticity, and security of clinical data. Click here to find out what other advantages to using an EDC system are and why it is a good idea to use an EDC made for medical devices.

Can I copy my paper CRF directly to the eCRF?

Concerned about the impact of adopting eCRF on clinical workflows? You might be wondering whether you can simply transcribe paper CRF documents into eCRF instead of requiring researchers to record data in a digital format.

You absolutely can choose to transcribe data into eCRF from paper source documents, however:

You will need to design a paper CRF and a matching eCRF to streamline the data entry process.

You will need to retain the source data in paper format to satisfy regulatory requirements.

The transcription process will introduce data entry errors that negatively impact data quality.

If your goal is to use eCRF in your study, designing your eCRF in a digital format is highly recommended, as your digital CRF can easily be transposed to a paper copy if needed. In contrast, it is often both time-consuming and costly to design a paper CRF and recreate it in a digital format.

However, we recommend designing your eCRF from scratch, instead of copying the design from the paper-based CRF. Download our eCRF template to get the design of your eCRF right.

How to design an eCRF

eCRFs are designed by clinical trial sponsors to collect data from a clinical investigation that can be used to test the experimental hypothesis and answer research questions that are relevant to the study.

A common mistake in eCRF design is trying to collect too much data. Including more data fields on your eCRF means more time and money spent on data collection, entry, preparation, and analysis. A well-designed eCRF should capture just the data needed for the study, without any time-consuming extras that lengthen the data collection process without adding anything useful.

To achieve this, trial sponsors should plan their clinical investigations and data collection activities in detail before designing an eCRF. Here’s how to start designing a high-quality eCRF:

1. Craft a Clear Hypothesis

The first step to designing an eCRF is to craft a clear research hypothesis for your clinical investigation. Your hypothesis should include a prediction for how your medical device will help patients in the treatment group.

Establishing a hypothesis is a critical step towards clarifying what data you must collect to support or refute your hypothesis, and what other data can safely be ignored in the context of your investigation.

2. Design a Statistical Analysis Plan

After establishing a hypothesis, you should prepare a Statistical Analysis Plan (SAP) describing how the data you collect during the clinical trial will be analyzed. This is when you’ll list exactly what data must be collected, and when, to enable a sound analysis that will either support or refute your research hypothesis.

Your SAP may also include descriptions of specific graphs, charts, or other visuals you hope to create using the data collected in your clinical trial.

3. Define Your Data Collection Plan

A data collection plan defines the specific questions you will ask to collect the data that’s needed to support or refute your research hypothesis. You can also document how those questions will be asked and how they might be formatted on a digital case report form (eCRF).

You can download our eCRF template to help you start documenting specifications for your eCRF as part of your data collection plan.

4. Plan your Data Collection Activity

Planning data collection activities means describing how researchers will collect, capture, and store data during your clinical trial. To solidify your plan, you’ll need to document the answers to questions like:

What data is available?

What data will be collected?

How much data will be needed?

How will the data be collected?

When will the data be collected?

Who will collect the data?

Where will data be recorded or stored?

How will data be shared?

By crafting a research hypothesis and establishing clear plans for gathering and analyzing your clinical data, you should be able to avoid the common mistake of collecting more data than is needed to test your research hypothesis.

This is only one of the 7 most common pitfalls in clinical data collection for MedTech that we have identified along the years. If you want to learn how to avoid tripping over these pitfalls (you may not even know you're doing it already), we suggest you check out our blog post, here .

5. Follow 7 Principles of Good eCRF Design

SMART-TRIAL EDC gives our customers the ability to design and customize eCRFs for medical device clinical investigations, clinical performance, post-market clinical follow-up (PMCF), and post-market performance follow-up (PMPF) studies.

To share our expertise, we’ve authored a white paper detailing the most important best practices in eCRF design. In the paper, we identify the seven principles behind a Good eCRF design and how you can apply them to create a perfectly optimized eCRF for your next clinical study.

What are the benefits of eCRF vs. Paper-based Reports?

1. eliminate unnecessary data duplication.

Medical device companies doing paper-based data collection must maintain a physical copy of the original source data for security and compliance purposes. Using eCRF in clinical trials eliminates the need for data duplication and allows medical device companies to satisfy these requirements by storing data securely in the cloud with appropriate back-ups.

2. Reduce or Eliminate Transcription Errors

Paper-based CRF forms must be transcribed into a computer database before analysis, which introduces the potential for transcription errors. Collecting data electronically with eCRF eliminates transcription errors and results in better quality data.

3. Streamline the Data Collection Process

When researchers complete paper CRFs in a study, those records must be packaged, shipped, and transcribed before the data can be analyzed. With eCRFs, any data collected by researchers during a subject visit is available for review and analysis in near-real time - just as soon as it’s entered into the EDC system.

Streamlining access to data accelerates the completion of clinical studies, provides a faster feedback loop for researchers, and enhances data access for all research stakeholders.

4. Facilitate Good Clinical Compliance

Collecting clinical data with eCRF can help medical device companies facilitate good compliance with clinical investigation standards like ISO 14155:2020 . EDC software can also deliver automatic warnings and notifications to help companies comply with Good Clinical Practices (GCP) as outlined by the International Conference on Harmonization (ICH).

Greenlight Guru Clinical's EDC software offers SMS and email notifications and comes with SOP and QA templates to facilitate ISO 14155:2020 and GCP compliance .

5. Facilitate Remote Data Monitoring

Clinical study monitors are responsible for ensuring that studies proceed in compliance with the experimental protocols, GCP, and relevant regulatory requirements. They also work to ensure that the rights of subjects are protected, and that study data is accurate and complete.

Using eCRF enables monitors to remotely access documentation from the clinical study over the Internet as an alternative to supervising the study in person. Remote monitoring reduces costs and increases the efficiency of clinical studies.

6. Enable Real-Time Data Access

Data recorded on eCRF is not constrained to a single physical location. Instead, the data is uploaded to the Internet where it can be accessed almost immediately by other stakeholders with the appropriate authorization and access credentials.

7. Mitigate Security Risks of Physical Paper

Paper CRFs are subject to a number of physical risks, including loss, theft, fire and water damage. Medical device companies can eliminate these risks by collecting data with eCRF and storing the data in a secure cloud environment.

8. Preserve Clinical Data for Audits

When clinical data is collected using eCRF in clinical trials and securely stored in the cloud, a digital data trail is created and preserved for inspector audits and regulatory review.

9. Reduce the Cost of Clinical Studies

Scientific research on the impact of choosing eCRFs over paper-based data collection have suggested that eCRFs accelerate the completion of clinical studies and reduce the cost of data collection. In one research paper that analyzed data collection in 27 clinical studies between 2001 and 2011, those using eCRF had a total cost of 374€ ( 381 usd) per patient, while those with paper-based data collection cost 1,135€ (1156 USD) per patient.

Design Your eCRF and Collect Clinical Data with Greenlight Guru Clinical

Greenlight Guru Clinical (formerly SMART-TRIAL) is an EDC system that enables clinical study sponsors to digitize the process of collecting, integrating, and securely storing data for clinical investigations, in-human studies, and post-market surveillance activities.

With Greenlight Guru Clinical, medical device companies can design highly customized eCRFs , then deploy those eCRFs in clinical studies to replace paper-based data collection, eliminate the risk of transcription errors, and reduce the cost of running the study.

As the first and only electronic data capture software designed for Medical Devices and Diagnostics, Greenlight Guru Clinical provides capabilities for gathering data in clinical studies, performance studies, PMCF/PMPF studies, surveys, registries, cohorts, case series, as well as from connected devices and wearables.

Ready to learn more? Contact us for a customized demo .

Páll Jóhannesson

Páll Jóhannesson, M.Sc. in Medical Market Access, is the founder and Managing Director of Greenlight Guru Clinical (formerly SMART-TRIAL). Páll was previously the CEO of Greenlight Guru Clinical where he led the team to create the only EDC specifically made for medical devices.

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Electronic Case Report Forms (eCRFs)

Case Report Forms
Electronic Data Capture
SUPER REDCap
REDCap Cloud

Case report forms and surveys are critical to pilot studies and clinical trials. The Weill Cornell Medicine’s Clinical & Translational Science Center (WCM CTSC) offers investigators access to Research Electronic Data Capture (REDCap), a web-based application supported by a consortium of over 6,000 institutions led by Vanderbilt University.

Using REDCap, an investigator can build case report forms and surveys using a point-and-click interface and then collect data to support single and multi-institutional studies. In contrast to tools like Microsoft Excel and Access, REDCap stores data on a secure server that is regularly backed up. Use of REDCap can improve quality and reduce time of data collection.

Offered as a premium service, SUPER REDCap enables pre-population of case report forms with data from electronic health record (EHR) and research systems. SUPER REDCap, which leverages the REDCap Dynamic Data Pull (DDP) plugin, provides an adjudication process whereby users can approve all incoming data from a source system (e.g. Epic) before saving it in a case report form. For example, a user can select a particular blood glucose value from a list of several available in the EHR to save to REDCap. SUPER REDCap is optimized for pre-populating one-time data such as patient demographics as well as data collected over time such as laboratory results and vital signs.

REDCap is available free of charge, but SUPER REDCap and other projects with sophisticated needs may require financial support from investigators. Although REDCap is capable of 21 CFR Part 11 compliance, REDCap is not currently validated for this purpose at WCM. For researchers in need of a 21 CFR Part 11-compliant solution, REDCap Cloud is offered as a premium service.

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A Case Report Form (CRF) is an electronic or paper document which is used in a clinical trial to record the protocol and required information about each participant. It enables efficient and complete data collection, processing, analysis and reporting. It is the main tool that Investigators use to collect information from clinical trial participants which is why there needs to be one completed CRF for each participant.

The Sponsor-Investigator puts together the CRF Completion Guidelines and ensures that the site staff have received training before collecting, entering and reviewing data.

All users are given a unique username and password to gain access to the CRF and the trial database. The Principal Investigator assigns permissions to each user which includes ‘data entry’ or ‘data view only’. Permission to access the data must be in accordance with the consent given by participants.

The CRF should be completed soon after each participant's initial visit which ensures that information can be followed up on while the participant is easily accessible.

All the data should be collected with users in mind and the requirements set out by regulatory agencies. The questions should be as clear and concise as possible to prevent any duplication.

Relationship to Protocol

The clinical trial protocol determines what kind of data should be collected - all the information found in the CRF should be specified by the protocol. Any data that will not be analyzed shouldn’t be included in the CRF.

Elements of a CRF

A Case Report Form consists of three main parts: a header, a safety-related module and an efficacy-related module.

Header

The header must contain key identification information including a study number, a site number and a participant ID number.

Safety Modules

Consists of the key safety analysis requirements found in the protocol which includes demographic information, adverse events, medical history, physical exam, deaths, drop-outs and eligibility confirmation.

Efficacy Modules

The protocol outlines the elements which are required in the efficacy modules. The elements of this module include the key efficacy endpoints of trial, additional tests to measure efficacy, how lesions will be measured and requited diagnostics.

CRF Development Process

The development of the CRF begins as soon as the development process begins. The responsibility of the design varies between Clinical Research Organizations, Clinical Research Associates, Data Managers, Research Nurses and Database Development.

The only data collected for the CRF should be what is required by the protocol- nothing more, nothing less. An interdisciplinary review is needed for every CRF:

Each company has its own process for review.
Should include the relevant staff members involved in the conduct, analysis and reporting of the clinical trial.

Properly and Poorly Designed CRFs

An effective CRF allows for components to be reused across the clinical trial, saving time and money.

A poorly designed CRF is one that is missing requested data or has unnecessary information meaning that it requires edits and modifications throughout the clinical trial.

CRF Completion

For a CRF to be completed, it needs to have:

Completed sections including headers with identifying items.
Relevant modifications.
A record of adverse events and specific documentation for any serious adverse events.

The data needs to be collected from the relevant source documentation (medical records) and entered into the CRFs by study personnel. Only designated members of the clinical trial staff are allowed to record or edit data in the CRFs.

Important Tips for Completion

The CRF Completion Guidelines should be followed to ensure that each CRF is accurate and completed in a timely manner.
Make sure the appropriate protocol, Investigator, and participant identifying information is included in the header.
Ensure the data is entered in the correct data field (provide boxes or lines to make it clear where the answers should be entered).
Use the appropriate units of measurement.
Be consistent.
Double-check spelling and grammar.
Watch for transcription errors.
Use the comment section to expand on any answer (be as concise as possible).
Use consistent formats, font style and font sizes.
Visual cues (boxes) which indicate the place and the format of data to be recorded.
Use check boxes.
Separate columns with thick lines.
Use precoded answer sets (male/female, yes/no and mild/moderate/severe, etc) wherever possible.

Electronic CRF (eCRF)

Ensures data integrity.
Provides an audit trail for data changes.
Ensures data preservation (automatic back-ups).
Essential identification information (protocol ID, site code and participant ID) will be generated from the first page to all other pages ensuring no duplication.
Linking data between 2 or more pages is easy.
There’s always the threat of losing valuable data due to software malfunction or if the eCRFs aren’t backed up successfully.

Confidentiality and Security

To protect confidential participant and clinical trial data, eCRFs must be stored on secure servers with restricted access, while paper CRFs must be stored in a secure location. Regular backups and archiving for future copies must be utilized.

Freezing the Database

Once the data has been finalized, it is necessary to lock the database which protects the integrity of the collected data and prevents any unauthorized edits from being made.

Case Series and Case Reports

First Online: 21 August 2024

Cite this chapter

Peter D. Fabricant MD, MPH 2

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Summary take-home points for case series and case reports:

Case series may be prospective or retrospective and are essentially single cohort observational studies.

Case series and case reports differ based on the number of study participants evaluated. Typically, case series have five or more patients included, while case reports have fewer than five patients.

Case series and case reports are classified as “level IV” evidence. This is the least rigorous level of evidence (except for expert opinion narratives).

Case series and case reports frequently use descriptive methodology without comparative statistics.

Despite the low level of evidence, case series and case reports comprise important works. They are ideal for reporting rare outcomes or complications, disseminating early clinical results from a new treatment technique, or piloting data to design and power prospective studies.

Case series and case reports
Pros	Cons
Quick and inexpensive to perform	Low statistical power
Can identify a topic for further investigation	Low likelihood of changing clinical practice
	May not be generalizable

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Hearing Loss Statistics 2024: More Common Than You Might Think

Key statistics.

Hearing loss affects about 60.7 million Americans age 12 and older. About 15.5% (44.1 million) of American adults age 20 and older have some level of hearing loss. [1] National Center for Health Statistics. Percentage of Any Difficulty Hearing for Adults Aged 18 and Over, United States, 2019–2022. National Health Interview Survey. Found on the internet at https://wwwn.cdc.gov/NHISDataQueryTool/SHS_adult/index.html [2] Goman, Adele M., et al. Addressing Estimated Hearing Loss in Adults in 2060. JAMA – Otolaryngology Head & Neck Surgery. July 2017. Found on the internet at https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5824202/ [3] Goman, Adele M. and Lin, Frank R. Prevalence of Hearing Loss by Severity in the United States. American Journal of Public Health. October 2016. Found on the internet at https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5024365/
Of people age 65 and older, 31.1% experience hearing loss, while 40.3% of adults age 75 and older experience hearing loss. [1] National Center for Health Statistics. Percentage of Any Difficulty Hearing for Adults Aged 18 and Over, United States, 2019—2022. National Health Interview Survey. Found on the internet at https://wwwn.cdc.gov/NHISDataQueryTool/SHS_adult/index.html
Around the world, about 70 million people are deaf (complete hearing loss). [4] United Nations. Sign Languages Unite Us! Found on the internet at https://www.un.org/en/observances/sign-languages-day
Studies show approximately 28.8 million American adults could significantly benefit from wearing a hearing aid. [5] National Institute on Deafness and Other Communication Disorders. Quick Statistics About Hearing Loss. March 25, 2021. Found on the internet at https://www.nidcd.nih.gov/health/statistics/quick-statistics-hearing
Only 16% of people age 20–69 have ever used a hearing aid, while just 30% of those age 70 and above have done so. [5] National Institute on Deafness and Other Communication Disorders. Quick Statistics About Hearing Loss. March 25, 2021. Found on the internet at https://www.nidcd.nih.gov/health/statistics/quick-statistics-hearing
Hearing loss is on the rise in the United States and is expected to almost double by the year 2060. [2] Goman, Adele M., et al. Addressing Estimated Hearing Loss in Adults in 2060. JAMA – Otolaryngology Head & Neck Surgery. July 2017. Found on the internet at https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5824202/

Our hearing ability can greatly impact our health. And hearing loss is a common and widespread issue worldwide.

Did you know 1.5 billion people—20% of the world’s population—have some degree of hearing loss ? [6] World Report on Hearing. World Health Organization. 2021. Found on the internet at https://apps.who.int/iris/rest/bitstreams/1334317/retrieve It’s currently the third-leading chronic health condition in the United States and cases are rapidly increasing. [7] Centers for Disease Control and Prevention. Loud Noise Can Cause Hearing Loss. Found on the internet at https://www.cdc.gov/nceh/hearing_loss/public_health_scientific_info.html Fortunately, half of all global cases are preventable through public education, early identification, and timely treatment. [6] World Report on Hearing. World Health Organization. 2021. Found on the internet at https://apps.who.int/iris/rest/bitstreams/1334317/retrieve

In order to understand the true scope of the issue, our Reviews Team dug into the latest research to help you protect your hearing and address suspected hearing loss.

Hearing loss facts

Hearing loss is unique to everyone and can occur at any age, although some types, causes, and symptoms are more common than others.

Types of hearing loss

The three primary types of hearing loss are conductive, sensorineural, and mixed hearing loss.

Hearing loss can affect one (unilateral) or both ears (bilateral), and severity ranges from mild to profound. In the United States,

Sensorineural hearing loss (SNHL) , particularly age related SNHL or presbycusis, is the most common type among older adults. [8] Cheslock, Megan and De Jesus, Orlando. Presbycusis. StatPearls. May 2023. Found on the internet at https://www.ncbi.nlm.nih.gov/books/NBK559220/
Among Americans age 12 and older, mild hearing loss was most common, affecting 37.1 million people. More than half (about 20.8 million) of those affected are adults age 60 and older. [3] Goman, Adele M. and Lin, Frank R. Prevalence of Hearing Loss by Severity in the United States. American Journal of Public Health. October 2016. Found on the internet at https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5024365/
An estimated 6.6 million Americans age 12 and older have severe to profound hearing loss in one or both ears, and 5 million are adults age 60 and older.

According to the World Health Organization (WHO) 2021 World Report on Hearing , 1.16 billion of the 1.50 billion people who have hearing loss have mild severity. Those with profound or complete hearing loss have the lowest prevalence rates at 0.2%, although both levels still account for a large number of people (29.8 million). [6] World Report on Hearing. World Health Organization. 2021. Found on the internet at https://apps.who.int/iris/rest/bitstreams/1334317/retrieve See Table 1 for a complete breakdown of hearing loss prevalence by severity level.

Table 1 Global number of people with hearing loss and percent prevalence by severity [6] World Report on Hearing. World Health Organization. 2021. Found on the internet at https://apps.who.int/iris/rest/bitstreams/1334317/retrieve

Hearing loss severity	Millions of people	Percent prevalence
Mild	115.3	14.9%
Moderate	266	3.4%
Moderately severe	103	1.3%
Severe	30.7	0.4%
Profound	17.2	0.2%
Complete	12.6	0.2%

Signs and symptoms of hearing loss

People experience hearing loss differently, depending on the type and severity. American Speech-Language-Hearing Association (ASHA) highlights common signs and symptoms, including: [9] Hearing Loss in Adults. American Speech-Language-Hearing Association. Found on the internet at https://www.asha.org/practice-portal/clinical-topics/hearing-loss/

Ringing in the ears
Speaking too loudly or quietly
Difficulty hearing conversations clearly in noisy environments
Frequently asking people to repeat themselves
Increasing cell phone volume or television beyond others’ comfort levels
Changes in behavior, like avoiding social gatherings

Tinnitus statistics

Ringing in the ears, known as tinnitus , is a type of hidden hearing loss symptom that can indicate auditory damage, often without a clinically significant difference in hearing. The most common cause of tinnitus is excessive noise exposure. [10] Zheng, Yunfang and Guan, Jianwei. Cochlear Synaptopathy: A Review of Hidden Hearing Loss. Journal of Otorhinolaryngology Disorders Treatments. March 2018. Found on the internet at https://sciforschenonline.org/journals/otorhinolaryngology-disorders-treatments/article-data/JODT-1-105/JODT-1-105.pdf According to research:

Up to 42.7% of the general population experience tinnitus
Up to 30% of the general population has reported that symptoms affect their daily lives
Tinnitus and other types of hidden hearing losses are increasingly common in young adults due to recreational noise exposure
The prevalence of tinnitus generally increases with age
Males are more likely to experience symptoms than females, but there’s no consensus as to whether males or females experience more severe symptoms

Causes of hearing loss

Sensorineural and conductive hearing loss have different causes, and mixed hearing loss is a combination of the two.

SNHL is caused by damage to the inner ear and auditory, or cochlear, nerve. As sound waves enter the ear, nerves in the inner ear convert the incoming sound wave vibrations into electrical signals, which are then carried by the auditory nerve to the brain to be translated into sounds. Damage can be caused by: [11] Sensorineural Hearing Loss. American Speech-Language-Hearing Association. Found on the internet at https://www.asha.org/public/hearing/sensorineural-hearing-loss/

Medical conditions that affect the inner ear: Head traumas, tumors, genetic syndromes, altered blood flow, infections, and inner ear conditions like Meniere’s disease can cause hearing loss. [9] Hearing Loss in Adults. American Speech-Language-Hearing Association. Found on the internet at https://www.asha.org/practice-portal/clinical-topics/hearing-loss/
Excessive noise exposure: About 40 million American adults between the ages of 20–69 have hearing loss caused by excessive noise exposure. While exposure to job-related noise is a piece of the puzzle, half of those affected did not have noisy jobs. Excessive noise is considered to be 85 decibels or louder for an extended amount of time, like using a leaf blower for two hours without ear protection. [12] Too Loud! For Too Long! Centers for Disease Control and Prevention. January 2020. Found on the internet at https://www.cdc.gov/vitalsigns/hearingloss/index.html
Certain medications that are toxic to the inner ear: Common medications like Gentamicin and certain chemotherapies are known to damage the inner ear. Tell-tale side effects include tinnitus and balance issues. [13] Cone, Barbara, et al. Ototoxic Medications (Medication Effects). American Speech-Language-Hearing Association. Found on the internet at https://www.asha.org/public/hearing/ototoxic-medications/

According to the Centers for Disease Control (CDC) , 50% of people age 12–35 years are at risk of hearing loss due to excessive sound exposure in recreational settings. [7] Centers for Disease Control and Prevention. Loud Noise Can Cause Hearing Loss. Found on the internet at https://www.cdc.gov/nceh/hearing_loss/public_health_scientific_info.html

Age-related hearing loss is a form of SNHL, often caused by degeneration of the inner ear’s structures over time, although additional damage due to noise, injury, health conditions, or certain medications can accelerate and worsen symptoms.

Conductive hearing loss is caused when sound signals can’t travel through the outer and middle part of the ear and is often treatable or reversible with medication or surgery. Sound obstruction can be caused by: [14] Conductive Hearing Loss. American Speech-Language-Hearing Association. Found on the internet at https://www.asha.org/public/hearing/conductive-hearing-loss/ [6] World Report on Hearing. World Health Organization. 2021. Found on the internet at https://apps.who.int/iris/rest/bitstreams/1334317/retrieve

Trapped fluids: Water, ear wax, inflammation, or fluid from infections can block sound waves from passing easily through the outer and middle ear. About 50% of older adults may be affected by impacted ear wax.
Genetic predisposition: A hole in the eardrum and altered formation of the outer and middle ear can affect how well sound waves travel through the ear.
Otosclerosis: The hardening of sound-conducting bones in the middle ear, which prohibits sound signals from traveling through the ear uninterrupted. This condition affects more than three million middle-aged Americans age 40–60, mostly women. [15] Otosclerosis. National Institute on Deafness and Other Communication Disorders. Found on the internet at https://www.nidcd.nih.gov/health/otosclerosis

Meniere’s disease statistics

Meniere’s disease is a condition known to cause SNHL, vertigo, and imbalance. Although the condition is rare, Meniere’s disease can have lasting effects on hearing, and episodes of vertigo can drastically affect people’s day-to-day lives by limiting mobility and independence. The most updated review we have found reported the following statistics: [16] Wright, Tony. Meniere’s Disease. BMJ Clinical Evidence. November 2015. Found on the internet at https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4636025/

Meniere’s disease is most common between ages 30–60
This condition has no known cause
Incidence ranges between 17–200 per 100,000 people each year, depending on the country
82% of people with Meniere’s disease develop moderate to severe hearing loss
In 60%–80% of cases, symptoms (other than hearing loss) improve over time regardless of the treatment approach

The cost of hearing loss

Hearing loss has major economic implications worldwide . According to a recent article published in 2021:

Global cost of hearing loss was about $980 billion
Reducing hearing loss by 5% could lower costs by $49 billion
More than 93% of costs were from teens and adults older than 14 years, and more than half (57%) were from low-income countries
These figures are expected to grow, but prevention efforts and early intervention could help mitigate costs [17] McDaid, David, et al. Estimating the Global Costs of Hearing Loss. International Journal of Audiology. February 2021. Found on the internet at https://www.tandfonline.com/doi/full/10.1080/14992027.2021.1883197

In the United States, health care costs associated with hearing loss are also high, particularly among those who go untreated. This is because untreated hearing loss is associated with higher rates of emergency department visits, hospital readmission, and longer hospital stays.

One study showed people with untreated hearing loss cost an average of $22,434 more than people without hearing loss over a 10 year period. [18] Reed, Nicholas S., et al. Trends in Health Care Costs and Utilization Associated With Untreated Hearing Loss Over 10 Years. Journal of the American Medical Association. January 2019. Found on the internet at https://jamanetwork.com/journals/jamaotolaryngology/article-abstract/2714049 Consider that more than 44 million American adults have hearing loss and only one in six Americans with hearing loss between ages 20–69 wear hearing aids (plus 30% of Americans age 70 and older). [5] National Institute on Deafness and Other Communication Disorders. Quick Statistics About Hearing Loss. March 25, 2021. Found on the internet at https://www.nidcd.nih.gov/health/statistics/quick-statistics-hearing

Fortunately, over-the-counter hearing aids are now available in the United States, making it easier for people to access and afford proper treatment for mild to moderate hearing loss.

Hearing loss is on the rise

The number of Americans with hearing loss is expected to increase from nearly 44.1 million adults in 2020 to 73.5 million by 2060, according to research . Projected rates of increased hearing loss by age are also concerning, as some hearing loss is estimated to rise by more than 150% in some age groups. [2] Goman, Adele M., et al. Addressing Estimated Hearing Loss in Adults in 2060. JAMA – Otolaryngology Head & Neck Surgery. July 2017. Found on the internet at https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5824202/

Globally, the WHO reported that 430 million people have at least moderate hearing loss and may benefit from a hearing aid, of which 34 million are children. By 2050, this number will rise to more than 700 million people.

The number of people with any degree of hearing loss is projected to increase from 1.5 billion to nearly 2.5 billion by 2050, according to the WHO. [19] Deafness and hearing loss. World Health Organization. February 2023. Found on the internet at https://www.who.int/health-topics/hearing-loss

Profound hearing loss and deafness statistics

The WHO defines deafness as having profound or total hearing loss, which means they have little to no ability to hear. Many who live with deafness use sign language to communicate. [19] Deafness and hearing loss. World Health Organization. February 2023. Found on the internet at https://www.who.int/health-topics/hearing-loss

Worldwide, 30 million people live with profound or complete hearing loss. [6] World Report on Hearing. World Health Organization. 2021. Found on the internet at https://apps.who.int/iris/rest/bitstreams/1334317/retrieve In the United States , 11 million people, or 3.6% of the population, have the same severity. [20] Deaf Demographics and Employment: Demographics Statistics. Rochester Institute of Technology. Found on the internet at https://infoguides.rit.edu/deafemploy/demographics

According to the United Nations and the World Federation of the Deaf : [4] United Nations. Sign Languages Unite Us! Found on the internet at https://www.un.org/en/observances/sign-languages-day [21] Who We Are. World Federation of the Deaf. Found on the internet at https://wfdeaf.org/who-we-are/

More than 130 countries host local and international advocacy events to support global human rights for those with partial and total hearing loss, including access to care and early intervention.
More than 80% of people with total hearing loss live in developing countries.
More than 300 different sign languages are used worldwide.

Average hearing loss by age

Currently, 55.4% of American adults with hearing loss are 70 years and older. Projections show this number will increase to 67.4% in the next four decades. Looking closer at specific age ranges in Tables 2 and 3, we can see more than a 156% projected increase in mild to complete hearing loss in those age 80 and above. [2] Goman, Adele M., et al. Addressing Estimated Hearing Loss in Adults in 2060. JAMA – Otolaryngology Head & Neck Surgery. July 2017. Found on the internet at https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5824202/

Table 2 40-year projected increase in mild hearing loss among Americans [2] Goman, Adele M., et al. Addressing Estimated Hearing Loss in Adults in 2060. JAMA – Otolaryngology Head & Neck Surgery. July 2017. Found on the internet at https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5824202/

Age group	Number of people with hearing loss, 2020	Number of people with hearing loss, 2060 projection	Projected percent increase in hearing loss
20–29	150,000	170,000	13.3%
30–39	450,000	520,000	13.5%
40–49	2,490,000	3,130,000	25.7%
50–59	4,440,000	5,250,000	18.2%
60–69	7,770,000	9,570,000	23.2%
70–79	8,900,000	14,270,000	60.3%
≥80	4,770,000	12,250,000	156.8%

Table 3 40-year projected increase in moderate to complete hearing loss among Americans [2] Goman, Adele M., et al. Addressing Estimated Hearing Loss in Adults in 2060. JAMA – Otolaryngology Head & Neck Surgery. July 2017. Found on the internet at https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5824202/

Age group	Number of people with hearing loss, 2020	Number of people with hearing loss, 2060 projection	Projected percent increase in hearing loss
20–29	30,000	30,000	0.0%
30–39	300,000	350,000	14.3%
40–49	190,000	240,000	26.3%
50–59	1,180,000	1,400,000	18.6%
60–69	2,610,000	3,220,000	23.4%
70–79	4,750,000	7,610,000	37.6%
≥80	6,020,000	15,450,000	156.6%

Hearing loss prevalence by state

The (CDC) released a report documenting hearing loss prevalence across all U.S. states and the District of Columbia between 2014 and 2016 (see Table 4). Most states (66%) had a prevalence that met or exceeded the national average of 15.9%. [22] Blackwell, DL and Norris, T. Any Hearing Loss by State: Estimates from the National Health Interview Survey, United States, 2014–2016. National Center for Health Statistics. October 2017. Found on the internet at https://www.cdc.gov/nchs/health_policy/disability.htm

West Virginia, Oregon, and Montana were the states where hearing loss was most prevalent, while the District of Columbia, New Jersey, Connecticut, and Maryland were the states where it was least prevalent.

The data also revealed regional trends in hearing loss prevalence:

Four out of the five states with the most prevalence were located in the western region of the United States
Eight of the 10 states (including the District of Columbia) with the least prevalence were on the east coast
Of the 18 states below the national average, 13 were on the east coast
63.6% of states that meet or exceed the national average lie west of the Mississippi River

Table 4 Estimated prevalence of hearing loss by state [22] Blackwell, DL and Norris, T. Any Hearing Loss by State: Estimates from the National Health Interview Survey, United States, 2014–2016. National Center for Health Statistics. October 2017. Found on the internet at https://www.cdc.gov/nchs/health_policy/disability.htm

State	Prevalence of hearing loss	% above or below the national average of 15.9%
Alabama	20.0%	+25.8%
Alaska	16.6%	+4.4%
Arizona	16.4%	+3.1%
Arkansas	21.4%	+34.6%
California	12.3%	-22.6%
Colorado	17.2%	+8.2%
Connecticut	11.0%	-30.8%
Delaware	14.3%	-10.1%
District of Columbia	8.6%	-45.9%
Florida	13.6%	-14.5%
Georgia	15.5%	-2.5%
Hawaii	14.5%	-8.8%
Idaho	23.1%	+45.3%
Illinois	16.3%	+1.9%
Indiana	18.3%	+15.2%
Iowa	20.3%	+27.7%
Kansas	18.1%	+13.8%
Kentucky	20.5%	+28.9%
Louisiana	18.5%	+16.4%
Maine	21.9%	+37.7%
Maryland	11.0%	-30.8%
Massachusetts	16.3%	+1.9%
Michigan	17.4%	+9.4%
Minnesota	18.7%	+17.6%
Mississippi	15.9%	0.0%
Missouri	19.1%	+20.1%
Montana	23.8%	+49.7%
Nebraska	20.7%	+30.2%
Nevada	12.9%	+18.9%
New Hampshire	18.0%	+13.2%
New Jersey	10.6%	-33.3%
New Mexico	20.8%	+30.8%
New York	12.6%	-20.8%
North Carolina	14.8%	-6.9%
North Dakota	20.9%	+31.5%
Ohio	18.8%	+18.2%
Oklahoma	17.5%	+10.1%
Oregon	24.6%	+54.7%
Pennsylvania	15.4%	-3.1%
Rhode Island	14.9%	-6.3%
South Carolina	14.6%	-8.2%
South Dakota	20.8%	+30.8%
Tennessee	21.0%	+32.1%
Texas	16.0%	+0.6%
Utah	15.9%	0.0%
Vermont	13.7%	-13.8%
Virginia	14.0%	-12.0%
Washington	20.0%	+25.8%
West Virginia	24.7%	+55.4%
Wisconsin	15.7%	-1.3%
Wyoming	22.3%	+40.6%

Hearing Loss Around The World

Nearly 430 million people globally have at least moderate hearing loss and would greatly benefit from a hearing aid.

The World Report on Hearing showed the Western Pacific region (including Australia, China, Japan, and New Zealand) accounted for 136.5 million people—the highest contribution of any region—with a 7.1% prevalence (see Table 5). North and South America accounted for 62.7 million people with a 6.2% prevalence. The U.S. national average prevalence rate of 15.9% is more than double the prevalence rate of the Western Pacific region. [6] World Report on Hearing. World Health Organization. 2021. Found on the internet at https://apps.who.int/iris/rest/bitstreams/1334317/retrieve

Table 5 Prevalence and cost of moderate hearing loss or greater by global regions [6] World Report on Hearing. World Health Organization. 2021. Found on the internet at https://apps.who.int/iris/rest/bitstreams/1334317/retrieve

Region	Number of people	Percent prevalence	Cost, in billions of dollars
Americas	62,700,000	6.2%	262
African	39,900,000	3.6%	27.1
European	57,300,000	6.2%	224.5
Eastern Mediterranean	22,100,000	3.1%	29.8
Southeast Asian	109,400,000	5.5%	107.7
Western Pacific	136,500,000	7.1%	328.3

The report also showed that hearing loss prevalence among the same 430 million people differed between income groups. Upper middle- and high-income groups had the highest prevalence at 6.2% and 7.5%, respectively (see Table 6). But of the $980 billion cost of unaddressed hearing loss, 53% came from low- and middle-income countries. [6] World Report on Hearing. World Health Organization. 2021. Found on the internet at https://apps.who.int/iris/rest/bitstreams/1334317/retrieve

Table 6 Global prevalence of moderate hearing loss or greater by relative income [6] World Report on Hearing. World Health Organization. 2021. Found on the internet at https://apps.who.int/iris/rest/bitstreams/1334317/retrieve

Income	Number of people (in millions)	Percent prevalence
Low income	23.4	3.3%
Lower-middle income	150.5	4.8%
Upper-middle income	166.4	6.2%
High income	87.7	7.5%

Gender and hearing loss

Gender analyses on hearing loss historically use a gender binary to report data.

The World Report on Hearing stated that among nearly 430 million people with moderate hearing loss or greater, males had a slightly higher prevalence than females. About 217 million males and 211 million females had at least moderate hearing loss at a 5.6% and 5.5% prevalence rate, respectively. [6] World Report on Hearing. World Health Organization. 2021. Found on the internet at https://apps.who.int/iris/rest/bitstreams/1334317/retrieve

The CDC reported an even larger prevalence gap of 22.7% between American male and female adults. In 2022, 17.6 million males age 18 and older reported some degree of hearing loss, while 13.6 million females reported the same.[1] According to a CDC National Health Interview Survey , only 7.1% of adults age 45 and older have used a hearing aid, with usage higher among men than women. [23] Madans, Jennifer H., et al. Hearing Difficulties Among Adults: United States, 2019. National Center for Health Statistics. July 2021. Found on the internet at https://www.cdc.gov/nchs/products/databriefs/db414.htm

The impact of hearing loss

Unaddressed hearing loss has a significant impact on communication, learning, employment, and overall health across all ages.

Hearing loss and educational outcomes

In children, unaddressed hearing loss can affect the ability to learn communication skills, subsequently affecting academic progression and career planning into adulthood. [24] Yong, Michael, et al. How the World’s Children Hear: A Narrative Review of School Hearing Screening Programs Globally. OTO Open. May 2020. Found on the internet at https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7238315/ Early detection and treatment, ideally before the age of six months, are essential in preventing developmental issues. [25] Yoshinaga-Itano, C. and Apuzzo ML. Identification of Hearing Loss After Age 18 Months is Not Early Enough. American Annals of the Deaf. December 1998. Found on the internet at https://pubmed.ncbi.nlm.nih.gov/9893323/

Similarly, American adults with unaddressed hearing loss achieve less education and have higher unemployment rates than those with unaffected hearing. People with unaddressed hearing loss are half as likely to achieve higher education, and those who are employed historically earn lower wages . [26] Jung, David and Bhattacharyya, Neil. Association of Hearing Loss with Decreased Employment and Income among Adults in the United States. Annals of Otology, Rhinology, and Laryngology. December 2012. Found on the internet at https://journals.sagepub.com/doi/10.1177/000348941212101201?url_ver=Z39.88-2003&rfr_id=ori:rid:crossref.org&rfr_dat=cr_pub%20%200 pubmed [27] Emmett, Susan D. and Francis, Howard W. The Socioeconomic Impact of Hearing Loss in U.S. Adults. Otology & Neurotology. March 2016. Found on the internet at https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4466103/ [28] Idstad, Mariann and Engdahl, Bo. Childhood Sensorineural Hearing Loss and Educational Attainment in Adulthood: Results from the HUNT Study. Ear Hear. November 2019. Found on the internet at https://pubmed.ncbi.nlm.nih.gov/30946138/

Hearing loss and health outcomes

Hearing loss has a large impact on mental and emotional health. Studies have found that those with varying degrees of unaddressed hearing loss experienced higher rates of social isolation, loneliness, depression, and anxiety. [29] Social isolation and Loneliness in Older Adults: Opportunities for the Health Care System. The National Academies Press. February 2020. Found on the internet at https://pubmed.ncbi.nlm.nih.gov/32510896/ [30] Shukla, Aishwarya, et al. Hearing Loss, Loneliness, and Social Isolation: a Systematic Review. Otolaryngology Head and Neck Surgery. March 2020. Found on the internet at https://pubmed.ncbi.nlm.nih.gov/32151193/ Further consequences included social withdrawal and cognitive decline , particularly in older adults and people in rural areas far from treatment and resources. [31] Hay-McCutcheon, Marcia J., et al. Positive Social Interaction and Hearing Loss in Older Adults Living in Rural and Urban Communities. Journal of Speech, Language, and Hearing. August 2018. Found on the internet at https://pubs.asha.org/doi/10.1044/2018_JSLHR-H-17-0485?url_ver=Z39.88-2003&rfr_id=ori:rid:crossref.org&rfr_dat=cr_pub%20%200pubmed [32] Rutherford, Bret R., et al. Sensation and Psychiatry: Linking Age-Related Hearing Loss to Late-Life Depression and Cognitive Decline. American Journal of Psychiatry. March 2018. Found on the internet at https://pubmed.ncbi.nlm.nih.gov/29202654/

Hearing loss severity is linked to higher rates of cognitive decline. [32] Rutherford, Bret R., et al. Sensation and Psychiatry: Linking Age-Related Hearing Loss to Late-Life Depression and Cognitive Decline. American Journal of Psychiatry. March 2018. Found on the internet at https://pubmed.ncbi.nlm.nih.gov/29202654/
Mild, moderate, and severe hearing loss increases the risk for dementia by two-, three-, and five-fold, respectively. [33] Lin, Frank R., et al. Hearing Loss and Incident Dementia. Journal of the American Medical Association. February 2011. Found on the internet at https://jamanetwork.com/journals/jamaneurology/fullarticle/802291
Compared to those with no hearing loss, those with at least moderate hearing loss have 23% lower odds of “emotional vitality” or happiness. [34] Contrera, Kevin J., et al. Association of Hearing Impairment and Emotional Vitality in Older Adults. Journals of Gerontology Series B: Psychological Sciences and Social Sciences. May 2016. Found on the internet at https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5013924/
Those who report hearing aid use at least five hours per week have significantly lower odds of depression. [35] Mener, David J., et al. Hearing Loss and Depression in Older Adults. Journal of the American Geriatrics Society. September 2013. Found on the internet at https://agsjournals.onlinelibrary.wiley.com/doi/10.1111/jgs.12429

Comparing research to clinical practice

Our Reviews Team asked Ruth Reisman , audiologist and co-founder of Urban Hearing in Brooklyn, New York, about her take on these statistics.

When we asked her about the expected rise in hearing loss cases, she responded, “As far as my private practices are concerned, my schedule is typically full, but I don’t believe the volume has increased any more than it’s been in the past.”

In a recent conversation with a colleague, she exchanged thoughts on how shocking it is that more people aren’t caring for their hearing in the same way teeth and eyes are cared for. “This may be because there is insufficient education or awareness surrounding hearing loss and its effects on the person’s quality of life,” Reisman said. “Oftentimes, people don’t believe it’s important enough until they lose their hearing.”

Regular visits to an audiologist could help catch reversible causes of hearing loss. Reisman estimated that 50% of the patients who visit her clinic for suspected hearing loss actually had the conductive type and just needed to address clogged ears, like excess ear wax. The other 50% included sensorineural hearing loss that would benefit from a hearing aid. Mixed hearing loss was not common in her practice, she said.

Consistent with research, Reisman said most of her patients have mild to moderate hearing loss. But most of these people are young- to middle-aged. Unfortunately, younger adults are more likely to be evaluated than older adults. “The reason is likely due to the fact they feel it’s affecting their quality of life,” she said, whether they’re having challenges hearing in various environments, or due to their active lifestyles. “And when told they have a mild hearing loss, they don’t necessarily take the next steps to treat the hearing loss.”

The health consequences of untreated hearing loss are apparent in clinical practice. Reisman told us that people with hearing loss have expressed feelings of isolation and challenges communicating with family members. “Some people also feel they need to stop working due to the challenges they experience. This can affect self-esteem and identity, which leads to potential depressive symptoms.”

Hearing loss prevention

According to the WHO, up to 50% of hearing loss can be prevented through lifestyle changes and public health initiatives. The monetary government investment, while steep, can be rewarding. An estimated $16 return can be expected for every dollar invested in hearing care services over a 10 year period. The WHO highlights key ways to prevent new cases or mitigate severity: [6] World Report on Hearing. World Health Organization. 2021. Found on the internet at https://apps.who.int/iris/rest/bitstreams/1334317/retrieve [19] Deafness and hearing loss. World Health Organization. February 2023. Found on the internet at https://www.who.int/health-topics/hearing-loss

Choosing to vaccinate children against diseases that may cause hearing loss, like rubella and measles
Educating expectant mothers on proper prenatal care
Implementing occupational initiatives to lower noise and chemical exposure that can damage hearing over time
Teaching safe listening in recreational settings like concerts
Avoiding medications known to cause hearing loss, when possible

Reisman shared the advice she gives to patients trying to prevent hearing loss or worsening symptoms. “Using generic hearing protection from the pharmacy will help to preserve hearing when exposed to loud noise, like during concerts or in loud work environments.” Her advice holds true for people who already have hearing loss, and who may not notice when noise is loud enough to be harmful. “Those with hearing loss are more susceptible to damage if exposed to loud noise, so they have an even higher obligation to wear hearing protection.”

Visit the Medicare Advocacy Organization and the Hearing Loss Association of America to learn how you can support initiatives that improve access to hearing care nationwide.

Bottom line

The prevalence of hearing loss is increasing rapidly, particularly among older adults. Prevention efforts are vital for protecting the global population from this growing health crisis and its consequential impact on economies, development, communication, and mental health.

If you suspect hearing loss, visit your local audiologist for a full examination. Ask your doctor about your treatment options and, if appropriate, consider buying one of the best hearing aids on the market so you can return to hearing the world as it should be.

Have questions about this article? Email us at [email protected] .

National Center for Health Statistics. Percentage of Any Difficulty Hearing for Adults Aged 18 and Over, United States, 2019–2022. National Health Interview Survey. Found on the internet at https://wwwn.cdc.gov/NHISDataQueryTool/SHS_adult/index.html
Goman, Adele M., et al. Addressing Estimated Hearing Loss in Adults in 2060. JAMA – Otolaryngology Head & Neck Surgery. July 2017. Found on the internet at https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5824202/
Goman, Adele M. and Lin, Frank R. Prevalence of Hearing Loss by Severity in the United States. American Journal of Public Health. October 2016. Found on the internet at https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5024365/
United Nations. Sign Languages Unite Us! Found on the internet at https://www.un.org/en/observances/sign-languages-day
National Institute on Deafness and Other Communication Disorders. Quick Statistics About Hearing Loss. March 25, 2021. Found on the internet at https://www.nidcd.nih.gov/health/statistics/quick-statistics-hearing
World Report on Hearing. World Health Organization. 2021. Found on the internet at https://apps.who.int/iris/rest/bitstreams/1334317/retrieve
Centers for Disease Control and Prevention. Loud Noise Can Cause Hearing Loss. Found on the internet at https://www.cdc.gov/nceh/hearing_loss/public_health_scientific_info.html
Cheslock, Megan and De Jesus, Orlando. Presbycusis. StatPearls. May 2023. Found on the internet at https://www.ncbi.nlm.nih.gov/books/NBK559220/
Hearing Loss in Adults. American Speech-Language-Hearing Association. Found on the internet at https://www.asha.org/practice-portal/clinical-topics/hearing-loss/
Zheng, Yunfang and Guan, Jianwei. Cochlear Synaptopathy: A Review of Hidden Hearing Loss. Journal of Otorhinolaryngology Disorders Treatments. March 2018. Found on the internet at https://sciforschenonline.org/journals/otorhinolaryngology-disorders-treatments/article-data/JODT-1-105/JODT-1-105.pdf
American Speech-Language-Hearing Association. Sensorineural Hearing Loss. Found on the internet at https://www.asha.org/public/hearing/sensorineural-hearing-loss/
Too Loud! For Too Long! Centers for Disease Control and Prevention. January 2020. Found on the internet at https://www.cdc.gov/vitalsigns/hearingloss/index.html
Cone, Barbara, et al. Ototoxic Medications (Medication Effects). American Speech-Language-Hearing Association. Found on the internet at https://www.asha.org/public/hearing/ototoxic-medications/
American Speech-Language-Hearing Association. Conductive Hearing Loss. =Found on the internet at https://www.asha.org/public/hearing/conductive-hearing-loss/
National Institute on Deafness and Other Communication Disorders.Otosclerosis. Found on the internet at https://www.nidcd.nih.gov/health/otosclerosis
Wright, Tony. Meniere’s Disease. BMJ Clinical Evidence. November 2015. Found on the internet at https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4636025/
McDaid, David, et al. Estimating the Global Costs of Hearing Loss. International Journal of Audiology. February 2021. Found on the internet at https://www.tandfonline.com/doi/full/10.1080/14992027.2021.1883197
Reed, Nicholas S., et al. Trends in Health Care Costs and Utilization Associated With Untreated Hearing Loss Over 10 Years. Journal of the American Medical Association. January 2019. Found on the internet at https://jamanetwork.com/journals/jamaotolaryngology/article-abstract/2714049
World Health Organization. Deafness and hearing loss. February 2023. Found on the internet at https://www.who.int/health-topics/hearing-loss
Rochester Institute of Technology. Deaf Demographics and Employment: Demographics Statistics. Found on the internet at https://infoguides.rit.edu/deafemploy/demographics
World Federation of the Deaf. Who We Are. Found on the internet at https://wfdeaf.org/who-we-are/
Blackwell, DL. and Norris, T. Any Hearing Loss by State: Estimates from the National Health Interview Survey, United States, 2014–2016. National Center for Health Statistics. October 2017. Found on the internet at https://www.cdc.gov/nchs/health_policy/disability.htm
Madans, Jennifer H., et al. Hearing Difficulties Among Adults: United States, 2019. National Center for Health Statistics. July 2021. Found on the internet at https://www.cdc.gov/nchs/products/databriefs/db414.htm
Yong, Michael, et al. How the World’s Children Hear: A Narrative Review of School Hearing Screening Programs Globally. OTO Open. May 2020. Found on the internet at https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7238315/
Yoshinaga-Itano, C. and Apuzzo ML. Identification of Hearing Loss After Age 18 Months is Not Early Enough. American Annals of the Deaf. December 1998. Found on the internet at https://pubmed.ncbi.nlm.nih.gov/9893323/
Jung, David and Bhattacharyya, Neil. Association of Hearing Loss with Decreased Employment and Income among Adults in the United States. Annals of Otology, Rhinology, and Laryngology. December 2012. Found on the internet at https://journals.sagepub.com/doi/10.1177/000348941212101201?url_ver=Z39.88-2003&rfr_id=ori:rid:crossref.org&rfr_dat=cr_pub%20%200pubmed
Emmett, Susan D. and Francis, Howard W. The Socioeconomic Impact of Hearing Loss in U.S. Adults. Otology & Neurotology. March 2016. Found on the internet at https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4466103/
Idstad, Mariann and Engdahl, Bo. Childhood Sensorineural Hearing Loss and Educational Attainment in Adulthood: Results from the HUNT Study. Ear Hear. November 2019. Found on the internet at https://pubmed.ncbi.nlm.nih.gov/30946138/
The National Academies Press. Social isolation and Loneliness in Older Adults: Opportunities for the Health Care System. February 2020. Found on the internet at https://pubmed.ncbi.nlm.nih.gov/32510896/
Shukla, Aishwarya, et al. Hearing Loss, Loneliness, and Social Isolation: a Systematic Review. Otolaryngology Head and Neck Surgery. March 2020. Found on the internet at https://pubmed.ncbi.nlm.nih.gov/32151193/
Hay-McCutcheon, Marcia J., et al. Positive Social Interaction and Hearing Loss in Older Adults Living in Rural and Urban Communities. Journal of Speech, Language, and Hearing. August 2018. Found on the internet at https://pubs.asha.org/doi/10.1044/2018_JSLHR-H-17-0485?url_ver=Z39.88-2003&rfr_id=ori:rid:crossref.org&rfr_dat=cr_pub%20%200pubmed
Rutherford, Bret R., et al. Sensation and Psychiatry: Linking Age-Related Hearing Loss to Late-Life Depression and Cognitive Decline. American Journal of Psychiatry. March 2018. Found on the internet at https://pubmed.ncbi.nlm.nih.gov/29202654/
Lin, Frank R., et al. Hearing Loss and Incident Dementia. Journal of the American Medical Association. February 2011. Found on the internet at https://jamanetwork.com/journals/jamaneurology/fullarticle/802291
Contrera, Kevin J., et al. Association of Hearing Impairment and Emotional Vitality in Older Adults. Journals of Gerontology Series B: Psychological Sciences and Social Sciences. May 2016. Found on the internet at https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5013924/
Mener, David J., et al. Hearing Loss and Depression in Older Adults. Journal of the American Geriatrics Society. September 2013. Found on the internet at https://agsjournals.onlinelibrary.wiley.com/doi/10.1111/jgs.12429

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J Med Case Rep

A guide to writing case reports for the Journal of Medical Case Reports and BioMed Central Research Notes

Richard a rison.

1 Presbyterian Intercommunity Hospital Health Stroke Program, Los Angeles County Medical Center, University of Southern California Keck School of Medicine, 12401 Washington Blvd, Whittier, CA 90602, USA

Case reports are a time-honored, important, integral, and accepted part of the medical literature. Both the Journal of Medical Case Reports and the Case Report section of BioMed Central Research Notes are committed to case report publication, and each have different criteria. Journal of Medical Case Reports was the world’s first international, PubMed-listed medical journal devoted to publishing case reports from all clinical disciplines and was launched in 2007. The Case Report section of BioMed Central Research Notes was created and began publishing case reports in 2012. Between the two of them, thousands of peer-reviewed case reports have now been published with a worldwide audience. Authors now also have Cases Database, a continually updated, freely accessible database of thousands of medical case reports from multiple publishers. This informal editorial outlines the process and mechanics of how and when to write a case report, and provides a brief look into the editorial process behind each of these complementary journals along with the author’s anecdotes in the hope of inspiring all authors (both novice and experienced) to write and continue writing case reports of all specialties. Useful hyperlinks are embedded throughout for easy and quick reference to style guidelines for both journals.

Introduction: the importance of case reports

Case reports are a time-honored tradition in the medical profession. From Hippocrates (460 B.C. to 370 B.C.), and even arguably further back since the papyrus records of ancient Egyptian medicine (c. 1600 B.C.) to modern day, physicians of all specialties have described interesting cases involving all specialties [ 1 , 2 ]. Published case reports provide essential information for optimal patient care because they can describe important scientific observations that are missed or undetected in clinical trials, and provide individual clinical insights thus expanding our knowledge base [ 3 ].

The publication of case reports has indeed become a standard lexicon of the medical literature. Examples abound. Few practicing physicians would not know for instance the significance and subsequent discovery of a disease whose first description in 1981 began with the title in the medical case report literature as: “A preliminary communication on extensively disseminated Kaposi’s sarcoma in a young homosexual man” [ 4 ]. There is no neurologist that I know who is unfamiliar with the disease whose description began in 1817 by James Parkinson (1755 to 1824) with the title “An essay on the shaking palsy.” [ 5 ].

Yes, both of the above-mentioned famous diseases (the acquired immunodeficiency syndrome and Parkinson’s disease) were first described in the case study format. The act of recording, discussion with colleagues, and publishing our clinical observations with patients remains essential to the art of medicine and patient care. As Osler once said “Always note and record the unusual…Publish it. Place it on permanent record as a short, concise note. Such communications are always of value.” [ 6 ].

But how and when should we do this? Early case reports were little more than personal communications between colleagues about unique and interesting patients seen in their respective medical practices. This anecdotal reporting has evolved into an accepted form of scholarly publication with the ability to rapidly disseminate knowledge to a broad medical audience [ 7 ] using the generally accepted format of a title, abstract, introduction (background), case presentation, discussion, conclusions, and references. Many biomedical journals publish case reports and provide authors with guidelines that provide instruction for acceptance criteria, content, and format and give advice on relevant patient case reports that merit publication [ 3 ].

There are already many well-written published articles on how and when to write a good case report (please see Recommended further reading section at the end). I will not re-invent the wheel, but within this editorial I hope to provide an informal guide on how and when to write a case report for BioMed Central (BMC), in particular the Journal of Medical Case Reports ( JMCR ) and BioMed Central Research Notes ( BMCRN ). The utility of the newly created Cases Database will also be discussed. Relevant and useful website links will be used throughout to allow the reader easy access to further information on BMC requirements. I also hope to impart to the reader a brief overview of case report editorial flow in both JMCR and BMCRN along with the complementary relationship between both journals. I will also give anecdotes of how I personally approach things.

Definitions

What exactly is a case report? From peer-reviewed journals to Wikipedia (and yes, I read Wikipedia like we all do) definitions are readily available and generally agreed upon. A simple online search shows the following definition from “thefreedictionary.com” [ 8 ]: “Case Report A report of a single case of a disease, usually with an unexpected presentation, which typically describes the findings, clinical course, and prognosis of the case, often accompanied by a review of other cases previously reported in the biomedical literature to put the reported case in context.” Wikipedia [ 9 ] has this to say: “In medicine, a case report is a detailed report of the symptoms, signs, diagnosis, treatment, and follow-up of an individual patient. Case reports may contain a demographic profile of the patient, but usually describe an unusual or novel occurrence. Some case reports also contain a literature review of other reported cases.” Whether one uses the above definitional references or older more classic ones [ 10 ], all are in agreement.

How to start: the patient

Things start at the bedside or in the office with the most important person involved: the patient. Patients and their stories (including from their friends, coworkers, and family) are our portal to writing the case report. Patients (both in-patients and out-patients) are assessed, we confer with colleagues, appropriate investigations then follow, and treatment if possible begins. If I encounter an in-patient on call then I follow him or her throughout his or her hospitalization and, I hope, timely discharge. The patient is then followed and reexamined in the office over the course of time to see how the clinical course evolves. I usually wait 6 months over the course of multiple visits before I actually begin to write a case report so as to allow enough time for the clinical course to play out. Of course if the patient is hospitalized with an acute and rapid illness then this time may be much shorter, but I still follow him or her with daily neurologic examinations.

Collegial discussion and the Internet: our modern day water cooler

When an interesting condition is encountered in either the hospital or the office setting, I discuss the case in person with both my local neurology colleagues and colleagues of other specialties to see if they have encountered before the clinical scenario that I am dealing with at the time. This is usually a quick face-to-face nursing station conversation. If the case is particularly challenging then I will contact my local university colleagues for their opinion (especially if an urgent transfer needs to be arranged). I then “hit the books”, or at least I used to. Nowadays I usually “hit the keyboards” which are plentiful at every hospital nursing station and in my office. Indeed, the Internet seems to have become our modern day replacement for office water cooler conversations. Since it is readily available (and free to me because I am a member of the staff) in the hospital in which I see patients and in my office, I usually start with UpToDate® [ 11 ] and then click the links to individual references. Further reading is then supplemented by both PubMed [ 12 ] (free) and Cases Database (also free) [ 13 ] (see later). If I feel that a particular patient warrants a case report, then I continue to read more and more. There are also medical list servers and medical online communities to which one can post a case with de-identified images online and petition the advice of colleagues worldwide. I use both Neurolist [ 14 ] (a membership-only service, but membership is free) and The American Academy of Neurology (AAN) for my specialty and/or subspecialties [ 15 ] (also a membership-only service, the fee of which comes out of my yearly AAN dues). Another useful list server is sermo® [ 16 ], which has free membership. Teaching grand rounds at one’s local university or hospital, poster presentations, and simple discussion with professors giving lectures at local seminars are also good (and previously “traditional”) places to start. I have always preferred an in-person encounter to discuss a case with a colleague or professor, but given the current day and age (daily workload, travel costs, time away from the office and family, and so on), I have found Internet-based discussion (keeping all patient information anonymous of course) very helpful.

The BMC series, JMCR , and BMCRN : a brief history

The BMC series is a group of open access, peer-reviewed journals that spans most areas of biological and clinical research. There are currently 65 journals in the series, including (alphabetically) BMC Anesthesiology to BMC Women’s Health. Some of these publish case reports within their respective disciplines, and some do not [ 17 ].

JMCR is an online, open access journal under BMC auspices dedicated mainly to the publication of high quality case reports, and aims to contribute to the expansion of current medical knowledge (please see specific publication criteria below). It was created and founded by Michael Kidd and colleagues in 2007 and at the time was believed to be the world’s first international medical journal devoted to publishing case reports from all clinical disciplines. In the 5 years since its launch, JMCR has published over 2000 case reports. In 2011, case reports were downloaded from the journal’s website over 1,500,000 times [ 18 ].

BMCRN is also an online, open access journal under BMC auspices publishing scientifically sound research across all fields of biology and medicine. The journal provides a home for short publications, case series, and incremental updates to previous work with the intention of reducing the loss suffered by the research community when such results remain unpublished. BMCRN began publishing case reports in 2012 and now has a dedicated section for case reports [ 19 ].

Please read on to see the complementary relationship of case reporting between the two journals, how they relate to other journals in the BMC series, and further information on editorial work flow including specific publication criteria.

Cases Database: an invaluable resource

Since the launch of JMCR in 2007 and the more recent introduction of case reports to the BMCRN , which aims to have a broader scope, BMC has acknowledged and continues to acknowledge the value of case reports to the scientific literature. To further strengthen this commitment, BMC in conjunction with Michael Kidd have developed the invaluable new resource of Cases Database, a continually updated, freely accessible database of thousands of medical case reports from multiple other publishers, including Springer, British Medical Journal, and PubMed Central. By aggregating case reports and facilitating comparison, Cases Database provides a simple resource to clinicians, researchers, regulators and patients to explore content and identify emerging trends [ 20 ].

http://www.casesdatabase.com/

I find Cases Database indispensable when I research a particular patient’s condition. It is very helpful in seeing if a particular condition has been reported before and what treatment the authors have performed. It is an invaluable resource which can be used to check and see if previous cases have been reported before and how other authors have managed their patients with similar clinical conditions. When I last checked, Cases Database had in its repository 27,915 peer-reviewed medical case reports from 250 journals (!) [ 13 ]. Cases Database is quickly becoming my first go to when reading about a patient’s condition and symptoms.

When to write a case report

How does one determine when to write an actual case report? What constitutes and what are the criteria for publication? Different journals have different criteria, but here are the criteria for JMCR and BMCRN .

JMCR [ 21 ] publishes original and interesting case reports that contribute significantly to medical knowledge. Manuscripts must meet one of the following criteria: unreported or unusual side effects or adverse interactions involving medications; unexpected or unusual presentations of a disease; new associations or variations in disease processes; presentations, diagnoses and/or management of new and emerging diseases; an unexpected association between diseases or symptoms; an unexpected event in the course of observing or treating a patient; findings that shed new light on the possible pathogenesis of a disease or an adverse effect.

http://www.jmedicalcasereports.com/authors/instructions/casereport

BMCRN [ 22 ] has somewhat different publication criteria: BMCRN considers medical case reports that describe any clinical case. Case reports submitted to BMCRN do not need to be novel, but must be authentic cases and have some educational value along with representing at least an incremental advance in the field. BMCRN will not consider case reports describing preventive or therapeutic interventions because these generally require stronger evidence.

http://www.biomedcentral.com/bmcresnotes/authors/instructions/casereport

Neither BMCRN nor JMCR will consider case reports where there are ethical concerns.

JMCR and BMCRN have the following definitions that authors should know: a single case report, two case reports, or a case series (greater than two reported cases). Both journals follow this format and accept submissions with these title structures.

I tend to classify case reports in my mind generally as follows: diagnosis-related, management-related, or both [ 10 ]. Either type should have clear and concise take-home messages and teaching points. I personally keep a stack of charts labeled “Curious Cases” on a bookshelf within my small office next to my desk which is always within my field of view at work, adhering to the “out of sight, out of mind” principle. Over the years that space has grown and, admittedly, I have cases dating back over the entire span of my years in practice (now over 13 years) which I simply have not gotten around to yet (!).

BMC editorial workflow for case reports: a brief glimpse

If a BMC Series journal editorial team considers a submitted case report unsuitable for their respective specialty journal (and now a growing list of Springer journals that BMC is now affiliated with), the authors are given the option to transfer their manuscript to BMCRN . If this option is exercised, then the BMC editorial team (usually the Case Report Section Editor for BMCRN in conjunction with the appropriate Associate Editor) determines if the manuscript is suitable for BMCRN or if it is more suitable for JMCR (based on the criteria listed above). The manuscripts will then be forwarded on to the respective Deputy and/or Associate Editors for peer review depending on which of the journals the author(s) agree(s) to. Peer reviewers are solicited (usually at least one at BMCRN and at least two at JMCR ). The peer review comments (which are open and identifiable at JMCR and blinded at BMCRN ) are then usually sent to the authors for appropriate revisions and rebuttals (unless it is felt that the manuscript should be rejected outright, at which time the editorial office sends the authors an explanatory letter). After these revisions and rebuttals have been performed, the revised manuscript and rebuttals are sent back to the respective editors for a final decision and recommendations. These decisions and recommendations are then forwarded on to the Editor-in-Chief for final approval for publication. At JMCR , manuscripts are professionally copyedited before being sent off to the production team for publication, whereas at BMCRN the authors are requested to obtain their own professional copyediting (if needed) before publication (the respective costs being reflected within the different article processing charges for both journals). When the manuscripts are published in both journals, they are in the preliminary form before being converted to the final form after production.

Author satisfaction consistently ranks high for the overall process in both journals.

The actual case report

Now let us discuss the brass tacks of writing the actual case report by going through the individual sections that will comprise the manuscript. I will present them in a sequence that matches the journals’ website requirements and provide easily accessible hyperlinks to both respective journals.

The first page of the manuscript should be a dedicated title page, including the title of the article. The title should be a clear and short description of the case with a list of the full names, institutional addresses and email addresses for all authors. There should always be at least one corresponding author who is clearly identified. Abbreviations within the title should always be avoided.

http://www.jmedicalcasereports.com/authors/instructions/casereport#formatting-title

http://www.biomedcentral.com/bmcresnotes/authors/instructions/casereport#title

I usually end the title with “…: a case report” or “…: two case reports” or “…: a case series”. I also try to avoid any puns or overly cute wording within the title and try to keep things strictly descriptive and clear. The title needs to accurately describe the case – after all, this may be all that someone reads. If a cute or clever title is used that obscures what the case is really about, then it may be even less likely that the manuscript is read.

The Abstract should be “short and sweet”. It should not exceed 350 words. Abbreviations or references within the Abstract should not be used. The Abstract should be structured into three sections: Background, an introduction about why this case is important and needs to be reported. Please include information on whether this is the first report of this kind in the literature; Case presentation, brief details of what the patient(s) presented with, including the patient’s age, sex and ethnic background; Conclusions, a brief conclusion of what the reader should learn from the case report and what the clinical impact will be. Is it an original case report of interest to a particular clinical specialty of medicine or will it have a broader clinical impact across medicine? Are any teaching points identified?

http://www.jmedicalcasereports.com/authors/instructions/casereport#formatting-abstract

http://www.biomedcentral.com/bmcresnotes/authors/instructions/casereport#abstract

I find this is the most important part because this is often all that people will read and its availability will allow easy retrieval from electronic databases and help researchers decide their level of interest in the case report. The Abstract should be a concise and condensed version of the case report and should include the same main sections of the main text and be as succinct as possible [ 3 ]. This is the last thing that I usually write as it tends to flow easily after I have invested my time in thought and writing of the manuscript.

This section is comprised of three to ten keywords representing the main content of the article. It is important for indexing the manuscript and easy online retrieval.

http://www.jmedicalcasereports.com/authors/instructions/casereport#formatting-keywords

http://www.biomedcentral.com/bmcresnotes/authors/instructions/casereport#formatting-keywords

Introduction (Background)

The Introduction ( JMCR ) or Background ( BMCRN ) section should explain the background of the case, including the disorder, usual presentation and progression, and an explanation of the presentation if it is a new disease. If it is a case discussing an adverse drug interaction the Introduction should give details of the drug’s common use and any previously reported side effects. It should also include a brief literature review. This should give an introduction to the case report from the standpoint of those without specialist knowledge in the area, clearly explaining the background of the topic. It should end with a very brief statement of what is being reported in the article.

http://www.jmedicalcasereports.com/authors/instructions/casereport#formatting-intro

http://www.biomedcentral.com/bmcresnotes/authors/instructions/casereport#background

The Introduction or Background serves as the sales pitch for the rest of the manuscript. It should be concise and salient [ 3 ] and immediately attract the reader’s attention to entice him or her to read on.

Case presentation

This should present all relevant details concerning the case. The Case presentation section should contain a description of the patient’s relevant demographic information (without adding any details that could lead to the identification of the patient); any relevant medical history of the patient; the patient's symptoms and signs; any tests that were carried out and a description of any treatment or intervention. If it is a case series, then details must be included for all patients. This section may be broken into subsections with appropriate subheadings.

http://www.jmedicalcasereports.com/authors/instructions/casereport#formatting-case

http://www.biomedcentral.com/bmcresnotes/authors/instructions/casereport#presentation

This is one of the most integral sections. The case should be described in a concise and chronological order. One should usually begin with the primary complaint, salient history (including significant family, occupational, and other social history along with any significant medications taken or allergies), followed by the physical examination, starting with the vital signs presented at the examination, along with pertinent investigations and results. There should be enough detail (but not too much) for the reader to establish his or her own conclusions about the validity. It should contain only pertinent information and nothing superfluous or confusing [ 3 ].

This is an optional section in JMCR for additional comments that provide additional relevant information not included in the case presentation, and that put the case in context or that explain specific treatment decisions.

http://www.jmedicalcasereports.com/authors/instructions/casereport#formatting-discussion

This section should evaluate the patient case for accuracy, validity, and uniqueness and compare and contrast the case report with the published literature. The authors should briefly summarize the published literature with contemporary references [ 3 ].

Although this section is optional in JMCR (and not even listed separately on the BMCRN guidelines website), I find that most authors write this section, or an expanded conclusions section incorporating the elements listed above.

I personally write a separate discussion section and conclusions section for each case report that I author.

Conclusions

This should state clearly the main conclusions of the case report and give a clear explanation of their importance and relevance. Is it an original case report of interest to a particular clinical specialty of medicine or will it have a broader clinical impact across medicine? Information should be included on how it will significantly advance our knowledge of a particular disease etiology or drug mechanism (if appropriate).

http://www.jmedicalcasereports.com/authors/instructions/casereport#formatting-conclusion

http://www.biomedcentral.com/bmcresnotes/authors/instructions/casereport#conclusions

This should be short and concise with clear take-home messages and teaching points [ 3 ].

Patient’s perspective

This section is an opportunity for patients to add a description of a case from their own perspective. The patients should be encouraged to state what originally made them seek medical advice, give a description of their symptoms, whether the symptoms were better or worse at different times, how tests and treatments affected them, and how the problem is now. This section can be written as deemed appropriate by the patients, but should not include identifying information that is irrelevant to the case reported. As medicine becomes more person-centered, the voice of the individual patient becomes even more important, both to assist in clinical decision making, and for medical education.

http://www.jmedicalcasereports.com/authors/instructions/casereport#formatting-patients

This optional section is unique to JMCR , and I believe adds an important new dimension to the traditional case report. Most authors still do not yet take advantage of this, but I hope as time goes on and more and more open access case report manuscripts are published that this section will be routinely used, not just in JMCR but also in BMCRN and all other BMC clinical journals. I recall one manuscript in particular where the patient himself was requesting publication as soon as possible because of his terminal disease. He wanted his message out there and be available to all to read before he died.

List of abbreviations

When abbreviations are used in the text they should be defined in the text at first use, and a list of abbreviations can be provided, which should precede the Competing interests and Authors’ contributions sections.

http://www.jmedicalcasereports.com/authors/instructions/casereport#formatting-abbreviations

http://www.biomedcentral.com/bmcresnotes/authors/instructions/casereport#formatting-abbreviations

Both JMCR and BMCRN publish case reports over a wide range of medical and surgical specialties, and it is important for the reader who may not be within that particular specialty to readily access a quick list of common technical abbreviations. Also, given the open access nature of both journals, please keep in mind that non-medical professionals may read the manuscript as well.

This section is compulsory for BMC. It should provide a statement to confirm that the patient has given their informed consent for the case report to be published. The written consent should not routinely be sent in along with the manuscript submission (because of patient privacy issues), but the BMC editorial office may request copies of the consent documentation at any time. The following wording is recommended: “Written informed consent was obtained from the patient for publication of this case report and accompanying images. A copy of the written consent is available for review by the Editor-in-Chief of this journal.” If the individual described in the case report is a minor, or unable to provide consent, then consent must be sought from his or her parents or legal guardians. In these cases, the statement in the ‘Consent’ section of the manuscript should be amended accordingly. Please keep in mind that manuscripts will not be peer reviewed if a statement of patient consent is not present.

http://www.jmedicalcasereports.com/authors/instructions/casereport#formatting-consent

http://www.biomedcentral.com/bmcresnotes/authors/instructions/casereport#consent

In practice, I always start with written consent from the patient. If the patient is incapacitated or deceased, then I obtain consent from the patient’s next-of-kin. Once this is obtained then I place it in the patient’s chart for safe keeping. I find that most patients and family members are quite agreeable to publication as long as their details are anonymous. BMC has very clear and explicit consent criteria and consent forms in multiple languages. I always keep a consent form within my office (and carry a few in my doctor’s handbag for hospital consults) for ready access. After I have obtained consent, I place it in the patient’s chart and keep it my office.

If the patient has died, then I try to obtain consent from the patient’s next-of-kin. This is usually done via telephone or postal mail. If the deceased patient’s family is amenable (and usually they are), then I send them (I never use email when it comes to patient-identifying information) the pre-filled out consent form in their language with a return envelope and paid for postage via the postal service. If I am unable to obtain consent this way in a case involving a patient who has died, then I write in the Consent section the following: “Written informed consent could not be obtained from the deceased patient’s next-of-kin for publication of this case report and accompanying images despite all reasonable attempts. Every effort has been made to protect the patient’s identity and there is no reason to believe that our patient would have objected to publication.”

If the patient was last known to be living but untraceable (or mentally incapacitated without next-of-kin consent), then I just simply do not publish the case.

For further information, please see JMCR and BMCRN website consent section hyperlinks as listed above.

Competing interests

A competing interest exists when one’s interpretation of data or presentation of information may be influenced by a personal or financial relationship with other people or organizations. Authors must disclose any financial competing interests and should also reveal any non-financial competing interests that may cause embarrassment were they to become public after the publication of the manuscript. Authors are required to complete a declaration of competing interests. All competing interests that are declared will be listed at the end of published article. Where an author gives no competing interests, the listing should read “The author(s) declare that they have no competing interests”.

http://www.jmedicalcasereports.com/authors/instructions/casereport#formatting-competing

http://www.biomedcentral.com/bmcresnotes/authors/instructions/casereport#formatting-competing

I do not usually find any problems with competing interests in the case reports that I publish, but the section should always be completed in our era and in the spirit of complete disclosure.

Authors’ contributions

In order to give appropriate credit to each author of a paper, the individual contributions of authors to the manuscript should be specified in this section.

An ‘author’ is generally considered to be someone who has made substantive intellectual contributions to a published study. To qualify as an author one should: 1) have made substantial contributions to conception and design, or acquisition of data, or analysis and interpretation of data; 2) have been involved in drafting the manuscript or revising it critically for important intellectual content; and 3) have given final approval of the version to be published. Each author should have participated sufficiently in the work to take public responsibility for appropriate portions of the content. Acquisition of funding, collection of data, or general supervision of the research group, alone, does not justify authorship. All contributors who do not meet the criteria for authorship should be listed in an Acknowledgements section. Examples of those who might be acknowledged include a person who provided purely technical help, writing assistance, or a department chair who provided only general support.

http://www.jmedicalcasereports.com/authors/instructions/casereport#formatting-contributions

http://www.biomedcentral.com/bmcresnotes/authors/instructions/casereport#formatting-contributions

I have found over the years a trend towards multi-authored case report manuscripts by many different individuals involved in the care of a patient(s). In my setting, it is usually me, a medical student or resident, a second-opinion tertiary colleague, and/or a pathologist or radiologist (if applicable). But I also recognize that there are situations that warrant more co-authors. The above criteria though for co-authorship should always be followed, and I have seen editorial situations where peer reviewers (including Associate Editors) have questioned what they felt was excessive authorship.

Authors’ information

This section includes any relevant information about the author(s) that may aid the reader’s interpretation of the article and understanding of the standpoint of the author(s). This may include details about the authors’ qualifications, current positions they hold at institutions or societies, or any other relevant background information. Please refer to authors using their initials. Note this section should not be used to describe any competing interests.

http://www.jmedicalcasereports.com/authors/instructions/casereport#formatting-information

http://www.biomedcentral.com/bmcresnotes/authors/instructions/casereport#formatting-information

In practice, I have frankly also personally used this section to advertise my services and “tout” my certifications and subspecialties (along with any co-authors and affiliated institutions) to my surrounding local community. This has in turn given me a modest increase in business (which has been completely non-monetary to date), usually in the form of email-based queries, many of which come from patients outside of my locality.

Acknowledgements

Authors should acknowledge anyone who contributed towards the article by making substantial contributions to conception, design, acquisition of data, or analysis and interpretation of data, or who was involved in drafting the manuscript or revising it critically for important intellectual content, but who does not meet the criteria for authorship. Also included should be the source(s) of funding for each author, and for the manuscript preparation. Authors must describe the role of the funding body, if any, in the: design, collection, analysis, and interpretation of data; writing of the manuscript; and decision to submit the manuscript for publication. Please also acknowledge anyone who contributed materials essential for the study. If a language editor has made significant revision of the manuscript, I recommend that you acknowledge the editor by name, where possible. Authors may also like to acknowledge (anonymously) the patient on whom the case report is based. If a scientific (medical) writer is used, this person should be included in the Acknowledgements section, including their source(s) of funding. Authors should obtain permission to acknowledge from all those mentioned in the Acknowledgements section.

http://www.jmedicalcasereports.com/authors/instructions/casereport#formatting-acknowledgements

http://www.biomedcentral.com/bmcresnotes/authors/instructions/casereport#formatting-acknowledgements

I have had colleagues who do not want to participate in the actual writing of the manuscript or do any actual “work” who have instead preferred to be mentioned in this section only.

Authors must search for and cite published case reports that are relevant to the case they are presenting. There should be no more than 15 references usually, although BMC does publish manuscripts with more references particularly if there is an extended literature review. Unless it is of historic interest, please keep the references as contemporary as feasible (for example, within the last 5 years or so). Please avoid excessive referencing.

http://www.jmedicalcasereports.com/authors/instructions/casereport#formatting-references

http://www.biomedcentral.com/bmcresnotes/authors/instructions/casereport#formatting-references

Cover letter

This is a separate document that should be written and uploaded with the main manuscript submission. I usually write this after I have written the Abstract. The cover letter should be addressed to the Editor-in-Chief in a formal manner and include all of the authors’ contact information. It should clearly and concisely state the title of the manuscript, and why the authors feel that their case report should be published based on any already available literature on the topic at hand. From an editor’s viewpoint, the cover letter is exceptionally important as that is the first thing that he or she reads and serves as the gateway to the Abstract and then the rest of the manuscript.

BMC author academy: help for all

Both JMCR and BMCRN have a large number of non-native English-speaking authors. Since JMCR and BMCRN are both BMC publications whose editorial offices are based in England, the language of publication is of course English. The BMC author academy is a joint program by BMC and Edanz [ 23 ] aimed at equipping writers for successful publication. Their materials have been developed from training workshops that Edanz gives to researchers worldwide and are not just limited to case reports. BMC recommends Edanz for authors who want to have their manuscript edited by a native speaker of English who is a scientific expert. Edanz provides scientific editing and related services that raise the quality of manuscripts to the standard needed to be understood at peer review.

http://www.biomedcentral.com/authors/authoracademy

I find that most non-native English-speaking authors have their manuscripts reviewed informally by a native English-speaking colleague and/or friend who is usually mentioned within the Acknowledgements section. This is understandable to keep costs down. However, please be aware that poor grammar and frequent spelling mistakes can be an impediment to editorial work flow and peer review. The editorial staff for both JMCR and BMCRN are acutely aware and sensitive to this given the large number of international submissions. At both JMCR and BMCRN , submitted manuscripts with questionable grammar and spelling are returned back to the authors by the editorial staff if it is felt that the grammar and spelling mistakes would impede peer review. If these issues are minor and it is felt that they would not impede peer review, then the manuscripts are sent off to peer reviewers (when appropriate).

Final checklist and the rule of C s

After I have completed a case report, I like to run through my long-winded (but useful) “rule of Cs” which is as follows.

Is it C lear, C oncise, and C oherent? Does it C onvey your message? Have you used C ases Database to look for any previously similar reported cases, and included them, if appropriate, in your references? Have you C onferred with your C olleagues on the C ontent? Will it C ause the reader to be C urious? Did you obtain C onsent? Does it C ontain all of the necessary information? Does it C omply with BM C guidelines? Do you think that it may need C opyediting? Do your C o-authors C oncur with the C ompleted paper? C an you C ut anything unnecessary out? Are your findings likely to be a C oincidence or by C hance alone? If so, then mention this in the Discussion section. Is the writing style C onsistent? Many times I find co-authored manuscripts have different writing styles within the same paper depending on who wrote what section. There should be a C entral, C orresponding author who is in C harge and oversees all of this. Is the C ase report written in a C hronological fashion with respect to the patient’s history and C hain of events? Is there anything that can be C ut out and have it still C ontain the C ompulsory information? Is it C oncise? Have you C onveyed C uriosity for your C ase report within your C over letter to the editorial team? Remember: your C over letter is the sales pitch to the editorial team! Make it C ount! Have you used within the manuscript C opyrighted information from another source? If so, do you need and/or have permission for use? After C ompletion, wait a C ouple of days before final submission to C lear your mind and read the manuscript again to C atch any mistakes that you may have made while you were C aught up in the C ompletion of it. Are the references C ontemporary? C an it be C omprehended by the average (“ C ”) reader? Remember, both JMCR and BMCRN are open access and freely available to anyone with an Internet C onnection and C omputer. C ast as wide a net as possible and C apture your C olleagues’ and other readers’ C uriosity. And first and foremost as a C linician: was the C are of your patient C ompetent and C ompassionate? (that is, are there any ethical concerns that may preclude peer review and publication?).

Summary and parting advice

Case reporting can be fun and a lifelong hobby, both for novice and experienced authors alike. It is now integral and widely accepted within published medical literature and today’s electronic information and data-sharing age. By following the above recommended steps and general overview, I hope to encourage BMC authors to continue to write and submit manuscripts to both JMCR and BMCRN . After your manuscript is complete, please follow the rule of “Cs”, especially “ C lear, C oncise, C oherent, C onsent, C ompassion, and C ompetence”, which will be appreciated by both reviewers and editors. Do not be afraid to obtain help from native English speakers for your manuscript. Also, please adhere to deadlines and follow instructions given by the editorial office, especially regarding any revisions. Editors read many different manuscripts and the longer it takes to get back a manuscript after revisions have been requested the less fresh that manuscript is in mind. Lastly, consider volunteering as an Associate Editor and/or reviewer within your specialty for both journals. I do for both, and the experience has improved both my writing and editing skills and daily interactions with patients.

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Basics of case report form designing in clinical research

Bellary, Shantala; Krishnankutty, Binny 1 ; Latha, M. S.

Global Medical Affairs, Dr. Reddy's Laboratories Ltd., Hyderabad, India

1 Clinical Research, USV Limited, Mumbai, India

Address for correspondence: Dr. M. S. Latha, G5, Mount Meru Apts., Road 5, Avenue 7, Banjara Hills, Hyderabad - 500 034, India. E-mail: [email protected]

This is an open-access article distributed under the terms of the Creative Commons Attribution-Noncommercial-Share Alike 3.0 Unported, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

INTRODUCTION

A case report form (CRF) is designed to collect the patient data in a clinical trial; its development represents a significant part of the clinical trial and can affect study success.[ 1 ] Site personnel capture the subject's data on the CRF, which is collected during their participation in a clinical trial. The International Conference on Harmonization Guidelines for Good Clinical Practice define the CRF as: A printed, optical or electronic document designed to record all of the protocol – required information to be reported to the sponsor on each trial subject.[ 2 ]

Case report form designing requires enormous planning and attention to minute detail. Designing a CRF is crucial in a clinical trial as it will aid in assessing the safety and efficacy of the medicinal product accurately. CRF should be designed for optimal collection of data in accordance with the study protocol compliance, regulatory requirements and shall enable the researcher test the hypothesis or answer the trial related questions.

A well-designed CRF should represent the essential contents of the study protocol and in an ideal situation, CRF is designed once the study protocol is finalized. It can be prepared either concurrently along with the protocol development, but may result in many versions, and hence needs to be version controlled. Timing of the design process will also play an important role as both the approaches have pros and cons.

It is increasingly recognized that the design of the CRF (paper form/electronic form) is a key quality step in ensuring the data required by the protocol, regulatory compliance and/or safety needs/comments, study-specific hypothesis attributes, site work flow, and cross-checking of data items within a form or across different forms are addressed.[ 3 ] The CRF used in clinical research reduces messy clinical realities to round integers and categorical answers.[ 4 ]

This article is an attempt to describe the methods of CRF designing in clinical research, discusses the challenges encountered and measures to be taken to prevent the occurrence of issues in its development.

PAPER CASE REPORT FORM VERSUS ELECTRONIC CASE REPORT FORM

There are two types of CRFs used in clinical research, that is, traditional paper CRF and improvised electronic CRF (eCRF). Paper CRF is the traditional way of data capture and a better option if studies are small or vary in design, whereas eCRFs are considered if studies are large with similar designs.[ 5 ]

In the current global scenario, eCRFs are preferred over paper CRFs as they are less time-consuming, and also encourage the sponsor/pharmaceutical company to carry out large multicentric studies at the same time due to the ease of administration. It is designed in such a way that data entry can be done with zero/minimal errors. Moreover, the regulatory authorities are readily accepting submissions in which validated electronic data capture (EDC) systems are used.[ 6 ]

While designing an eCRF, repetitive data such as protocol ID, site code, subject ID, and patient initials will be generated by the system automatically from the first page to all others, thus ensuring no duplication of CRF pages.

In eCRF, linking the data between two related pages of CRFs becomes easy and quick. They have built-in edit checks tagged to each data field as well as to the CRF as a whole. Therefore, majority of data cleaning activities will take place during the completion of the eCRFs, thus reducing the time and effort required by data management personnel. Instant query resolution reduces the time spent on obtaining the clarification from the site/investigator and hence, clean data is obtained much quickly, resulting in timely database lock, faster regulatory submission, and subsequent approval.

Designing a paper CRF is a tedious job that could result in data errors and wrong conclusions, requiring meticulous attention to minimize duplication of CRF pages. Chances of error during data transfer from the source document to paper CRF are common. Moreover, for studies with large sample size if traditional method of data collection through paper CRFs is opted, then manual data cleaning may be a major concern. However, this method may not require user training and system validation as in the case of EDC systems, where such things are essential before implementing it. Despite their many advantages, eCRFs have not been accepted widely. Main reasons behind this are lack of available on-site technology, investigators’ lack of motivation, complexity of installation, and maintenance of the software and high investment cost.

STANDARD CASE REPORT FORM DESIGN

Designing a CRF is an art that should to be based on scientific practices and the design should be implemented keeping the end-user (the one who enters data in the CRF) in mind. While designing, all important sections of the CRF should be included with care; always it is worth to remember that insufficient/inaccurate data collection would prove expensive during analysis. Hence, it is advisable to have a standard operating procedure for CRF preparation and to follow best practices of CRF designing.

Primary objective of CRF designing is to gather complete and accurate data by avoiding duplication and facilitating transcription of data from source documents onto the CRF. CRF should be designed with the primary safety and efficacy endpoints as the main goal of data collection.[ 6 ] Ideally, it should be well-structured, easy to complete without much assistance and should collect data of the highest quality. Always minimum amount of data needed to answer the study hypotheses should be collected avoiding collection of elaborate, unimportant information. For ordinal data, to ensure uniformity and clarity among raters, adequate explanation should be provided adjacent to the CRF fields. Capturing the same piece of data in more than one place (duplication) on the CRF should also be avoided. In other words, CRF should collect data in sufficient detail without ambiguity and at the same time, should avoid redundancy and avoid capture of unwanted details. Hence, striking the perfect chords to ensure balance between effective data collection and structuring the CRF to support accurate data entry is essential. Collecting the data in the coded form whenever possible is ideal as it facilitates data entry (at CRF and at the database levels) and helps the statistician in data interpretation and analysis.

Important part of the CRF is an informative header and footer, which can be customized.[ 7 ] In general, the header includes protocol ID, site code, subject ID, and patient initials. Whereas, the footer includes investigator's signature, date of signature, version number, and page number.

In order to enhance easy reading/understanding and accurate data entry, an uncrowded CRF layout should be preferred. Placing too many details on the same page, makes the CRF look cluttered and makes data entry difficult, which eventually leads to increase in data discrepancies.

Case report form design should be standardized to address the needs of all those who handle the data such as investigator, data manager, biostatistician, clinical research monitor/coordinator, database developer/programmer and data entry personnel etc. An effective CRF design would always be user friendly. Moreover, it should capture legible, consistent and valid data, thereby, reducing query generations.[ 7 ] While designing the CRFs, design standards should be adhered to for improving the quality of data collected. Hence, data should be organized in a format that facilitates data analysis and makes it simplified.

The following points are to be borne in mind while designing a CRF:

Use of consistent formats, font style and font sizes throughout the CRF booklet
Selection of portrait versus landscape versus combination layouts
Use of clear and concise questions, prompts, and instructions
Visual cues, such as boxes that clearly indicate place and format of data to be recorded should be provided to the person recording the data as much as possible
Using the option of “circling of answers” should be limited as it's hard to interpret; instead check boxes would be appropriate
Clear guidance about skip patterns like what to skip and what not to skip should be mentioned at appropriate places
Skips (are instructions provided in the CRF page to maintain the connectivity between pages) should be kept to a minimum by the placement of questions to avoid confusions
Provide boxes or separate lines to hold the answers. This indirectly informs the data recorder where to write/enter the response and helps to differentiate it visually from the entry fields for other questions
Separate the columns with thick lines
Provide bold and italicized instructions
Minimize free text responses
Position only specified density of questions on each page
Page numbering if necessary, should be consistent throughout
Avoid using “check all that apply” as it forces assumptions about the clinical data
Specify the unit of measurement
Indicate the number of decimal places to be recorded
Use standard data format (e.g., dd/mm/yyyy) throughout the CRF
Use precoded answer sets such as yes/no, male/female, method of administration of medicine, and severity of adverse event (AE) (mild/moderate/severe) wherever possible
Not to split modules/sections (a set of one or more related groups of questions that pertain to a single clinical study visit) like, for example, AE section should not be split and laid across pages such that information related to a single AE will have to be collected from different pages
Use “no carbon required (NCR)” copies to ensure exact replica of CRF
Use instructions including page numbers where data has to be entered (e.g., during a follow-up visit, the investigator is supposed to record whether any AE has occurred and if occurred, details of the AE has to be recorded in the AE module. Hence, the field corresponding to this question on the module for the particular visit would be having the options “yes” or “no”. There should be an instruction “If ‘yes’, please provide the information in the AEs page (page no. XX)” as shown in Figure 1 .

WELL DESIGNED CASE REPORT FORM VERSUS POORLY DESIGNED CASE REPORT FORM

Table 1 provides the comparison between well-designed and poorly designed CRF. In case of poorly designed CRF, by placing a single line for required response results in variations in the investigator's responses from site to site. On the other hand, separate lines and boxes are provided in the well-designed form, which gives the visual cues about what is expected as a response and thereby, reduces the unnecessary queries. Usually, boxes are used for entering dates and the date format (i.e., dd/mm/yyyy) should be consistent on all pages of CRF. Units and decimal points should be displayed for vital sign records, which clarify the user about the expected values and also facilitates the data interpretation and reduces manipulation during analysis procedures. Figures 2 and 3 are examples of poorly designed CRFs. Poor CRF design results in frequent database modification thus affecting the study timelines. Data need to be collected in a way that does not introduce bias or errors. Collection of a large amount of data will result in wasted resources in collecting and processing it. Questions in the CRF should be clear and unambiguous to avoid unnecessary confusions.[ 8 ]

In some circumstances, data can be obtained using derivation procedures; collection of derived data again on the CRF should be avoided to minimize calculation errors. For example, age can be calculated using date of birth. Body mass index can be calculated using height and weight of the subject, only the latter two should be captured.

In conditions where same parameters are to be recorded at multiple visits, it is recommended to use the same CRF module for each visit to reduce the number of query generation. For example, vital Signs and body systems in the physical examination (PE) module can be collected in the same order each time.

In some places, answers are coded in order to simplify the data collection. When codes are used to obtain an answer for a question, consistency in codes should be maintained throughout the CRF booklet and there should not be any variation in the answer for the same question.

For example, yes/no answers are coded as 1 = yes and 2 = no (preferred coding) as shown in Figure 4 . If the codes are assigned in this order, the same order should be practiced throughout the CRF. Nowhere in the same CRF “1” should be coded for “no” and “2” should be coded for “yes”.

Even the location of these codes on the CRF should be consistent; same is shown in Figure 4 . Clear instructions should be provided to the user where ever necessary; otherwise, it will have a significant impact on the data management activities like database designing, data cleaning, data validation, and data extraction due to poor understanding of the site personnel about the expected responses. It is advisable to use indicator questions wherever needed to avoid assumptions about the data. Use indicator questions in connection to a set of other questions, and the response to the indicator question would decide on whether the associated set of questions needs to be answered or not. For example, in an AE question group, an indicator question could be, “Did any AE occur after the last visit?”

If the response is “yes”, the remaining questions pertaining to the details of the AE(s) (such as severity, seriousness, causality, date of onset, date of resolution, and action taken) require responses. If the response is “no”, the rest of the question group is not answered. Incorporation of an indicator question and skips are shown in Figure 1 . Ideally, CRF booklet should have a chart reflecting the expected list of assessments as per schedule specified in the protocol.

STANDARD CASE REPORT FORM TEMPLATES

Some of the data requirements such as demography, PE, AEs are same across studies, so standard CRF templates should be developed which can be customized accordingly. These templates are of great help while conducting multiple studies in the same research area. These templates will have the same design principles that help the user to enter data with ease since the design is familiar to them; there is no need for special training on these modules of CRFs.

A “library” of standard templates should be established and maintained by the sponsor/contract research organizations, pharmaceutical companies in order to maintain uniformity in the CRF design and to save time. Most commonly used standard CRF templates are inclusion criteria, exclusion criteria, demography, medical history, PE, AE, concomitant medication and study outcome modules, whereas, the modules which captures efficacy data are not unique. Their design varies from study to study depending on the protocol specifications.

CASE REPORT FORM CONNECTIVITY/WELL REFERENCED CASE REPORT FORMS

Linking of CRF (paper CRF and eCRF) pages wherever necessary is known as CRF connectivity. Each CRF booklet is assigned with unique subject ID and it is the duty of site personnel to make sure that same ID is entered on all pages of CRF booklet. Consistently entered subject ID will help in tracking the missing CRF pages. The fields such as protocol ID, site code, subject ID, and patient initials make database designing easier and helps linking CRF pages to the study database. The fields like protocol ID and visit labels are informative features as they provide brief descriptions of the study and the schedule of assessments, respectively. The CRF version number is a critical field that prevents an incorrect CRF page being used. All pages of the CRF booklet should be numbered in sequential order, which will help in identifying queries through data validation procedures and manual reviews. Page numbering not only provides the site personnel with a quick reference to specific pages, but also helps to design the database in a structured manner. Especially, in case of eCRF, retrieving of CRFs becomes challenging if proper programming is not carried out. CRF connectivity is crucial when statistical analysis plan (SAP) is complex and these fields will be of help in statistical analysis.

CHALLENGES IN CASE REPORT FORM DESIGNING

Commonly encountered challenges in CRF designing are consistency in the design, collection of precise data and user-friendliness. These challenges can be overcome by proper planning by a team of data management personnel, biostatisticians, clinicians, and medical writers. Objectives should be defined clearly before designing. Consistent design is a crucial aspect as it reduces the number of mistakes in data entry. It is of great advantage when using them across various studies. Maintaining standard CRF templates would resolve this issue. Collection of extraneous data is another issue and measures should be taken to avoid it, as processing this becomes tedious. In such instances, ensuring accuracy and quality become major challenges. Attention should be paid to avoid duplication. Design the CRF to avoid referential and redundant data collection. For example, collecting calculated fields/derivable data should be avoided and to ensure that data collection is cost-effective. Designing user-friendly CRF to reduce data entry errors is again a challenge. Simple/standard designs should be incorporated wherever possible.

User feedback mechanism should be built into the CRF design and maintenance process. Best practices should be applied to improve the data quality and save time with CRF design. Providing CRF completion guideline aids in minimizing the challenges in data capture and data entry.

CASE REPORT FORM COMPLETION GUIDELINES

A CRF completion guideline is a document to assist the investigator to complete the CRF in a step by step manner and is drafted concurrently in line with the CRF and protocol. Figure 5 shows sample page of CRF completion guideline. There is no standard template for CRF completion guidelines as it is study specific. It should be prepared in such a way that it enables the site personnel to complete the CRFs with ease and legibility. CRF completion manual should provide clear instructions to site personnel for accurate completion of CRFs along with clear expectations including proper instructions on handling unknown data. For example, if exact date is unknown, then use a preferred notation in the place of missing value (i.e., UK/UNK/2012). The language used should be simple with clear instructions, concise, and easy to understand.

Case report form completion guidelines document, while bridging the gap between the study protocol and the data collection process, explains the activities involved in CRF completion, correction, signing, and data handling.[ 7 ] It provides unambiguous instructions on CRF completion in all practical scenarios. For example, if data were wrongly entered and the site personnel wants to correct it, the instruction provided would be to strike-through the incorrect data with a single line, put the initials (of the person who makes the change) with date and to write the correct entry in the margin against the corresponding line. Similarly, instructions will be provided for each data entry field on each page in the CRF booklet. This helps to ensure completion of all required data fields and enhances the data flow.[ 7 ] CRF completion guidelines could be a separate document or could be a part of the CRF booklet giving page by page instructions. If it is included as part of the CRF, it is advisable to print instructions on the page facing the CRF page (back side of the previous page) as the investigator can easily take instructions and simultaneously fill the CRF page. CRF completion guidelines document should have version control and amendments should be done as and when required.

Case report form design is the initial step in translating the protocol into standard questionnaires and is paramount to a successful clinical trial. Standard CRF should be designed in such a way that it helps the collection of consistent and valid data, ultimately resulting in submission of data to regulatory authorities and its acceptance. Regardless of the time and effort spent conducting the trial, the correct data points (response to a CRF question/data is entered) must be collected; otherwise, a meaningful analysis may not be possible. Therefore, a sound SAP should be used as a tool to develop and judge the adequacy of the CRF, which should be available to guide on what data points need to be captured on the CRF. To avoid future amendments, it is important to have design principles in mind well in advance before CRF designing is initiated. These standard guidelines will contribute in preparing a well-designed CRF for data acquisition.

ACKNOWLEDGMENT

We would like to acknowledge the technical support offered by Mr. Vinoth T. and Mr. Sagi Subbaraju that has helped us during the preparation of this article.

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Source of Support: Nil.

Conflict of Interest: None declared.

Case report form; completion guidelines; case report form design; electronic case report form; standard templates

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