Data collected in the frame of a clinical trial must be recorded in order to ensure that the protocol is complied with and as a basis for the analysis of the study results.
Case Report Form
A Case Report Form is a document recording all the patient information, as required by the study protocol, which must be reported to the sponsor.
CRF in the European Union
A CRF enables the collection of all data that are needed for the conduct of the clinical trial and for the analysis of its results. This information includes, but is not limited to, the patient vital signs, his/her medical history, all the patients examination and tests results, and the adverse events. The CRF can be paper-based or electronic.