Case Report Form
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Case Report Form (CRF) A printed, optical, or electronic document designed to record all of the clinical protocol required information to be reported to the sponsor on each clinical trial subject.
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Design of Case Report Forms
A case report form is a printed or electronic document that is designed to collect the required research, administrative, and regulatory data for a clinical trial. The measurement and recording of the trial data for are perhaps the mast critical steps in the overall data management process, and it is therefore important that the CRFs be designed with clarity and ease of use in mind. The design of CRFs has a direct impact on the quality of the data collected for a clinical trial, so it is worthwhile to take time over the design and development of the forms and to develop a layout that is user-friendly. Case report forms should always be available before a trial is activated. Activating a trial without the CRFs in place is likely to result in a clinical trial with incomplete and inconsistent data. Therefore the urgency to activate a trial should always be balanced by the need to have these important tools in place. It is recommended that forms be piloted by some of the trial participants prior to activation of a trial. The piloting can be done by completing the proposed forms using historical data from appropriate medical records available at the sites. This process allows the eventual users of the forms to have meaningful input into the design and piloting the use of the forms can often identify problems that can be corrected prior to implementation of the forms in real time.
Format of Questions and Coding Conventions
The purpose of case report forms is to collect complete and unambiguous data for the clinical trial and to ensure standardization and consistency of data across participating sites. Their format should be designed with three functions in mind:
- Recording data on the form
- Data entry into the computer
- Data retrieval for analysis
The person recording data on the form should be able to answer the questions and record the answers in an unambiguous and effective way, minimizing any possibility of misinterpretation or transcription errors; the person who is entering the data into the computer should be able to transcribe values from the form to the keyboard with minimum effort in following the flow of data and entering the data values; the person who is analyzing the data must be able to interface the data and the statistical software with a minimum of data conversion. Even if the data are not computerized but tabulated manually, it is important to design the forms with analysis in mind.
Multiple Choice Format. For a specific question all possible answers are displayed on the form, and the user has to circle/check the correct answer. This format is usually used if optical scanning is going to be used to convert the answers into electronic format.
Reference
ICH1 Guidance E6: Good Clinical Practice: Consolidated guideline (http://www.hc-sc.gc.ca/hpfb-dgpsa/tpd-dpt/e6_e.html)
External links
- ICH Website (http://www.ich.org)
- FDA Website (http://www.fda.gov/)
- Clinical Research Training (http://www.kriger.com/training/index.htm)
- Careers in Clinical Research (http://www.biorole.com/)
- Clinical Research Services (http://www.clinqua.com/)
- Clinical Research Companies Listings (http://www.ibpassociation.com)
- International Clinical Research Services and Corporate Trainings (http://www.kriger.com/)
- Clinical Research Abbreviations and Acronyms (http://www.krctraining.com/ACRONYMS/index.htm)
- Clinical Research Glossary / Definitions (http://www.krctraining.com/CRA%20Definitions/index.htm)
- List of Food and Drugs Regulatory Agencies (http://www.kriger.com/international_modules/index.htm)
- Clinical Research: Frequently asked questions (http://www.krctraining.com/faq/faq.htm)
