Which records document that consent is obtained in accordance with GCP and protocol and dated prior to participation of each subject in trial, and also document direct access permission?

• A. Relevant Communications Other Than Site Visits
• B. Signed Informed Consent Forms
• C. Source Documents
• D. Monitoring Visit Reports

Answer: (A)

In GCP, the evidence that a subject’s consent was obtained before any trial procedures and that the sponsor and study personnel may access the subject’s records for verification rests in the source documents. Source documents are the original records that support the data and the conduct of the trial. They include the signed informed consent forms, which show that consent was obtained and dated prior to participation, and they often contain the statements needed for permission to access the subject’s records for monitoring, auditing, and regulatory review. Because they are the primary records bearing witness to what happened and when, they are the records you would rely on to confirm both proper consent and direct access permission.

Other items listed are not the primary evidence of consent and access. Monitoring visit reports describe oversight activities, not the consent itself; communications outside of site visits are not the formal documentation of consent; and while signed informed consent forms are a key part of source data, the broader category that captures both consent timing and access permissions is the set of source documents.