CRF stands for Case Report Form and is defined 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”
In other words, a Case Report Form in a clinical trial can be a printed or electronic document that study team members complete in the clinic. It is then sent directly from a laboratory to the data management centre.
What are the types of case report forms (CRF) in Clinical Research?
There are two main types of CRFs: Paper-Based CRF and electronic CRF ( eCRF).
1. Paper-Based CRF:
This type of CRFs is used in traditional clinical trials, to collect and record data about the participants in the clinical trials, including their demographics, adverse events, and treatment results.
Advantages of using Paper CRF:
- Lower cost and affordability
- Familiarity and easy to use
- Rapid and easy availability
- Physical proof and storage
Disadvantages of using Paper CRF:
- Data entry error
- Delays in Transcription
- Storage and Security
- Data Quality
- Monitoring Cost
2. Electronic CRF or eCRF:
In Clinical trials, the Electronic Case Report Form or eCRF is a digital form of a questionnaire or in other words it is a digital form of the traditional case report form, that is used to collect and report data about the participants.
Advantages of eCRF:
- Accessibility
- Quality and accuracy of data
- Time-saving
- Provides an audit trail for data changes.
- Traceability
- Data Security
Disadvantages of eCRF:
- Technical Problems
- Infrasture development
- Needs training
- Implementation cost
- Maintenance cost
Purpose of Case Report Forms in Clinical Trials
The main purpose of Case Report Forms in clinical research is to record all the information needed to complete the data analyses used to assess the outcomes of the clinical trial study. CRFs gather study data in a standardized format so that the data can be entered into a computerised database and analysed.
Design of Case Report Form
- The most important document during a clinical study is the protocol and CRFs are a vital part of it.
- A well-structured Case Report Form in clinical trials simplifies the database design.
- The quality of the study data relies on the quality of the Case Report Forms used to collect the data.
Properly Managed CRF: Properly Managed Case Report Forms in clinical research ensure the accuracy of the collected data, regulatory compliance and the streamlined clinical trial process
Poorly Managed CRF Development: Poorly managed CRF development leads to inaccurate data, compliance issues, and inefficiencies in clinical trials.
What is Protocol?
Protocol is a document that describes the background, rationale, objective, design, methodology, statistical considerations and organization of a clinical research study.
Development of CRF
- Several factors contribute to ensuring that a CRF is easily understood and used:
- Layout of the Case Report Form
- A Case Report Form consists of three main parts: a header, a safety-related module and an efficacy-related module.
- Section and Concise question wording
- Use of minimal text field responses
- Avoid redundant data collection
- Formats, font of the text, and alignment of the document
- Perfect White space, not too much and not too less
- Pay layout of the CRF
- Log forms such as Medical history or adverse events
- Standard CRF header, including title of the protocol, subject number and standard visit date, time and name.
Points to Consider While Designing and Developing CRF
- First and the most important step is to translate the protocol into data.
- Consider inputs from the entire Clinical Research study team
- The design of the Case Report Form should be taken into consideration before the protocol is finalized.
- The quality of both protocol and CRF improves, with they are designed concurrently.
- Case Report Forms should not include data that ultimately will be used for analysis.
- All the data of CRF must be attributable to a subject
- All Case Report Forms must contain a provision for the investigator’s signature
- The use of a standard data structure is advised as the data collected on CRFs will be consolidated for statistical analysis.
