A Case Report Form (CRF) is the structured tool used to collect protocol-required data for each clinical trial participant.
CRFs capture demographic, efficacy, safety, and endpoint data according to prespecified formats. They serve as a primary mechanism for transforming clinical observations into analyzable trial datasets. Accurate CRF completion supports database quality, statistical analysis, and regulatory submission readiness. CRFs may be paper-based or electronic, depending on study design and systems used.