Source Documents: What is the purpose of source documents in a clinical trial?

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

Answer: (A)

Source documents are the original records that provide the evidence of what actually happened during a participant’s trial participation. They are the source of truth for every data point recorded in the case report form, showing when events occurred and what was observed or measured. This creates an auditable trail that supports data integrity, regulatory compliance, and participant safety by allowing reviewers to verify that the data entered into the study records truly reflect the facts as they happened.

Informed consent forms, for example, document that the participant agreed to participate, which is essential but serves a different purpose from providing the original data for verification. Monitoring visit reports document oversight activities, and certificates of analysis report lab or product quality. Each has an important role, but the primary function of source documents is to supply the verifiable, original data used to confirm the study data.