Case Report Form
A case report form (CRF) is a document that is created and used in clinical trials to capture standardized study data from each patient to answer the research question. A unique identifier is usually assigned to each patient to ensure that personal data and other identifying information are not disclosed.
The study sponsor is responsible for creating the case report form according to the standard operating procedures (SOP) outlined in the study protocol. They are also responsible for monitoring and auditing the collected data to ensure it is organized, understandable, reproducible, reliable, updated, and verified for accuracy.
The case report form is meant to preserve and maintain the quality and integrity of clinical data. This includes basic information, such as:
- Date of visit or observation
- Blood pressure
It also includes more detailed information, such as:
- Assessment as to whether the patient met inclusion / exclusion criteria
- Associated test records, such as EKGs, lab tests, scans, and x-rays
- Adverse events (AEs) and serious adverse events (SAEs)
- Concomitant therapies
- Dropouts and the reasons
- Intercurrent illnesses
An eCRF (electronic case report form) is a digital version of a case report form. Often, an eCRF is a web-based application. eCRFs are replacing paper-based CRFs for a number of reasons, including:
Case Report Form Design
Case report form design is conducted according to standard operating procedures (SOP) guiding the study protocol. The SOP ensures that the CRF design uses a format that supports accurate input, presentation, verification, audit, and inspection of the recorded data.
The SOP also directs optimal data collection for protocol compliance and regulatory requirements, and enables the researcher to test the hypothesis or answer study-related questions. The case report design should include fields to capture all essential data while keeping the number of questions to a minimum.
The research team (e.g., operations manager, investigator, site coordinator, study monitor, data entry personnel, medical coder, statistician) should be part of the case report form design process.
CRF Design Principles
When designing a case report form, general principles to consider include:
- Components are organized in chronological order, clearly identifying the visit or data collection point
- Designated area for sign-off, at eligibility review, and at the end of the CRF
- Fields are organized to enter data into the case report form in a logical order—e.g., follows the order of study procedures during a trial session
- Free-text entries are kept to a minimum
- The header on every page provides relevant identifying information—e.g., trial name, protocol number, patient trial number
- Indications are included as to which case report form pages are applicable to particular visits
- Minimal calculations and conversions are required (ideally none)
- Only data related to the trial is collected, with attention paid to avoiding duplications
- Predetermined answers (e.g., yes / no, mild / moderate / severe) are provided wherever possible
- Questions, prompts, and instructions are presented clearly and concisely
- Sections of the CRF are separated by visit
- A standardized format is used to provide consistency in data recording
- The case report form is version controlled, with version number and date at a minimum
CRF Formatting and Layout Considerations
Recommendations for the case report form design team to consider include:
- Avoid using “select all that apply” for answers
- Format bold and italicized text for instructions
- Indicate the number of decimal places to be recorded with pre-placed decimal points, where applicable
- Provide boxes or lines where the answers should be filled in
- Separate columns and sections with thick lines
- Specify units, if appropriate
- Standardize the format for repeated information, such as date (e.g., dd/mm/yyyy)
- Use checkboxes rather than “circling answers”
- Use clear and concise questions, prompts, and instructions
- Use consistent formats, font style, and font sizes
- Use page numbering consistently for forms with multiple pages
- Use portrait versus landscape layout
Well-Designed vs. Poorly-Designed Case Report Forms
Well-designed case report forms ensure that data can be collected accurately and efficiently. A well-designed CRF also minimizes data queries and facilitates data management, statistical analysis, and reporting.
The example below compares a well-designed case report form to one that is poorly designed. A few best practices to note on the well-designed CRF form are:
- Separate boxes for data built in to gather data in the correct format (i.e., dd/mm/yyyy)
- Decimal points are included with following boxes to indicate the correct format
- Options for units of measurement included
Case Report Form Templates
Establishing a library of case report form templates expedites the design of individual CRFs and ensures consistency in data collection.
A final CRF is generally not a single form, but a series of individual case report forms that gather data related to the trial. Standard operating procedures direct the design and data collected in each CFR as set forth by the study protocol.
Examples of the forms that might be included in the complete study CRF are:
- 1. Baseline assessment or vital signs form
- 2. Clinical report form
- 3. Concomitant medications form
- 4. Demographic information form
- 5. Documentation of informed consent
- 6. End-of-study form
- 7. Enrollment form
- 8. Health care proxy form
- 9. Medical history form
- 10. Physical or general examination form
- 11. Pre-existing and Adverse Events (AE) form
- 12. Randomization form
- 13. Screening or eligibility form
- 14. Self-report form
- 15. Serious Adverse Events (SAE) form
- 16. Study visit forms
Case Report Form Connectivity
The linking of case report forms (paper CRF and eCRF) pages is known as case report form connectivity. To help keep all parts of the final CRF connected, individual CRFs should include the unique subject ID assigned to each patient.
Other information to include on CRF documents to make database designing easier and enable case report form connectivity are:
- Protocol ID
- Visit labels
- Site code
- Patient initials
Case Report Form Challenges
Three commonly encountered CRF design challenges include:
- 1. Collection of precise data
- 2. Consistency in the design
- 3. User-friendliness
Addressing these issues with a well-designed case report form increases engagement, reduces data errors, and streamlines data processing and management.
Ways to overcome these challenges include:
- Define clear objectives
- Follow best practices for CRF design
- Include cross-functional team members such as biostatisticians, clinicians, and data managers
- Provide case report form completion guidelines
- Solicit user feedback
- Take time for proper planning, starting at the beginning of the study
Case Report Form Completion
Case report form completion guidelines provide assistance to users and help ensure data quality. The CRF completion guidelines should include step-by-step instructions about how data should be entered, as well as any direction about acceptable abbreviations, corrections, and approvals required before submission. As with the CRF, the completion guidelines should be clear and concise.
Items commonly included in case report form completion guidelines:
- Abbreviations and acronyms should be avoided.
- All CRF pages should be signed and dated by the person completing the form.
- Complete each field using leading zeros for those that require numbers.
- The case report form must be completed by authorized personnel, as documented on the SOP.
- Data entries should be checked to confirm that they are consistent with the source data.
- Do not record incomplete dates (e.g., if month and year are known, but not the day, record it as uk/mm/yyyy).
- Do not write outside of the designated spaces or boxes.
- Every field on each CRF page should be filled in unless otherwise indicated or if it is not done (ND), unknown (UK), or not applicable (NA).
- Handwritten entries should be neat and legible to others.
- Header information should be included on each page in a consistent format.
- If a medication was given for an Adverse Event or another reason, document the drug, start / stop dates, and response.
- Record dates in the requested format (e.g., 11/04/2015; April 11, 2015; Apr 11 2015)
- To amend incorrect data on a paper case report form page:
- Score through the error with a single line
- Do not obscure the original entry (i.e., do not use correction fluid)
- Write the correct data nearby
- Initial and date each amendment
- Units of measurement (e.g., kg/lb, cm/in) should be included.
- Write comments on the comments section / page—not in other spaces or boxes.
Get the Most Out of Clinical Research
Data collection is at the heart of clinical research, and case report forms are critical to the quality and efficacy of this information.
Well-designed case report forms give researchers quick access to the data they need to create study reports. Higher-quality and more quickly accessible data enables researchers to deliver results and complete clinical studies faster. Top-quality data also improves the overall integrity and efficacy of the studies.
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Last Updated: 10th October, 2021