Which term is defined as a printed, optical, or electronic document designed to record all protocol-required information to be reported to the sponsor on each trial subject?

• A. Case Report Form (CRF)
• B. Confidentiality
• C. Contract
• D. Clinical Trial/Study

Answer: (A)

The Case Report Form (CRF) is the printed, optical, or electronic document used to record all protocol-required information for each trial subject that must be reported to the sponsor. It serves as the primary data collection tool, aligning with the protocol’s endpoints and data points so data are captured consistently across subjects and sites. CRFs support data management, monitoring, and regulatory reporting by providing a complete, auditable record of each participant’s trial data. This distinguishes them from confidentiality, which deals with protecting participant privacy; from contracts, which are legal agreements; and from the clinical trial/study itself, which is the overall project rather than the data-collection instrument.