case report forms

A case report form (or CRF) is a paper or electronic questionnaire(s) specifically used in clinical trial research.

The Case Report Form is the tool used by the sponsor of a clinical trial to collect data from each participating site. All data on each patient participating in a clinical trial are held and/or documented in the CRF, including adverse events.
The sponsor of the clinical trial develops the CRF to collect the specific data they need in order to test their hypotheses or answer their research questions. The extent of a CRF can range from a handwritten one-time ‘snapshot’ of a patient’s physical condition to many hundreds of pages of electronically captured data obtained over a period of time. (It can also include records of required check-up visits months after the patient’s treatment has stopped.)

The sponsor is responsible for designing a CRF that accurately represents the protocol of the clinical trial, as well as managing its production, monitoring the data collection and auditing the content of the filled-in CRFs.

Good form design helps both the clinician and patient enter / record accurate information, and handwritten forms have the advantage of speed, quick selection using tick box answers and the benefit of hard copy recording for audit management.