Case Report Form (CRF)

Case report forms (CRFs) are the official documentation of a clinical trial. The primary purpose of CRFs is to collect [Page 68]research data, whereas the primary purpose of source documents is to care for study subjects from a clinical perspective. The study researchers design these documents to collect only the data necessary to support the research hypothesis. The information in the CRFs provides the basis for the final clinical study report. These data are used in any study-related publications. This information is also necessary for regulatory approval of a new drug.

CRFs must reflect the study protocol exactly. All the information requested in the study protocol must be reflected in these documents. Only information requested in the study protocol is necessary. Unrequested information is not included in the analysis or in the final report. The clinical study protocol specifies what information is to be recorded on the CRF. A clinical research site's standard operating procedures outline the proper methods for completing these forms, review of these forms for accurate transcription from source documents, and the time frame for retaining these forms.

CRFs are the official documentation of the clinical trial for the regulatory authorities, and together with the source documents are closely examined during an audit or inspection.