The Case Report Form (CRF) is a tool used in clinical research in the form of paper or an electronic questionnaire by clinical research sponsors to gather and record information about patients participating in the research. The main objective of CRFs is to preserve and maintain the integrity and quality of data collected. CRFs are important to every clinical research project because they contain all the data about every single participating patient.
Designing of a standardized CRF across research projects may serve to lower costs involved in the collection of large data sets from large numbers of patients. A CRF needs to be designed keeping in mind the needs of all users like the clinical investigators, statisticians, site coordinators, etc.
An ideal CRF design should include a compliance with the study protocol that is outlined prior to designing a CRF, commitment to regulatory requirements; avoid duplication of data, and the ability to enable investigators to answer trial related tests. An ideal CRF therefore must consist of the essential study protocol elements. A well-designed CRF is becoming more important for clinical researchers in order to avoid later complications in safety issues, crosschecks, regulatory inspections, etc.
While paper based CRFs dominate the clinical research sector, there is a quicker adoption of electronic CRFs due to the advantages of
- higher quality data retention
- reduce data entry time
- greater discrepancy management
- faster database access for crosschecks
- ability to organize large data sets in a simple manner
The significance of a good CRF is underestimated because a poorly designed CRF can lead to the collection of too much data, or too little data or simply wrong data. The CRF's importance centers on data collection and hence it of importance to know what should constitute a CRF.
First and foremost, the study protocol of the clinical research will determine what sets of data will be collected. It is often helpful to list a table of data variables that the protocol mentions should be collected.
The following are some points that are useful in designing a CRF:
- Consistent formats throughout the CRF booklet
- Use of clear and concise questions and instructions
- Visual cues indicating place and format of data
- Provision of separate spaces in the booklet for answers
- Guidance about skipping questions and minimizing number of queries skipped
- Avoid usage of "check all that apply" since it can increase assumptions about clinical data
- Use of pre-coded answer sets like yes/no/, male/female, etc. which can quicken data collection where possible
- Administrative data should be collected only when necessary like "visits missed"
- Avoid open-ended questions because it will cause confusion during the analysis