Which document serves as the formal record that a subject has given informed consent and is used as part of trial data?

• A. Certificates of Analysis
• B. Source Documents
• C. Monitoring Visit Reports
• D. Signed Informed Consent Forms

Answer: (D)

The essential idea is documenting that a participant agreed to join the study and that their agreement is tied to the data collected. The signed informed consent form is the formal record of that agreement. It confirms the participant was informed about the study, understood the information, and consented before any study procedures began. This document is kept as part of the trial’s regulatory and data records, and the data collected from the participant are linked to this consent status. Other documents listed serve different purposes—Certificates of Analysis relate to product quality, monitoring visit reports cover site oversight, and source documents are where study data are first recorded, not specifically the record of consent. Therefore, the signed informed consent form is the correct choice because it directly documents that consent and is used in conjunction with trial data.