Case report form

In clinical studies, a Case Report Form, or CRF for short, is the data entry form used to document anonymized or pseudonymized patient data. In accordance with the protocol, the CRF contains data on the patient's medical history, clinical data, test results, laboratory data, concomitant medication, information on the effect and side effects of drugs or medical devices, serious adverse events (SAE) and quality of life.

The CRF can, for example, use visual analogue scales (VAS) to measure the satisfaction of study patients and investigators. The documentation in the CRF may only be performed by persons (investigators or study nurses) authorized by the principal investigator of a study site. The sponsor must ensure that Case Report Forms and the source data are securely stored for at least 10 years.

According to GCP, the following rules must be observed in documentation: Case Report Forms must be kept correctly, completely and legibly. Corrections must be dated and signed so that the original entry is still legible. All data in the test sheet must be documented in the source data, CRFs are not accepted as source data.

The accuracy of CRFs is ensured by the Clinical Research Organisation (CRO) with the help of monitoring. During monitoring, the Clinical Research Associate (CRA) compares the CRFs with the source data (source data verification). Furthermore, the monitor checks the CRF for plausibility and completeness and, in case of deviations or implausible data, sends queries to the study centers, which are answered by the study physician.

The CRF can be paper-based or electronically managed as an eCRF, although sponsors and contract research organisations increasingly prefer eCRFs.