Which document confirms the PI’s agreement to permit auditing at the study site?

The Informed Consent Form (ICF) typically includes a statement indicating that the participant's records may be reviewed by monitors, auditors, and regulatory authorities. This ensures transparency and compliance with regulatory requirements, allowing for audits and inspections when necessary.

This answer follows GCP guidelines which specify that the ICF should include consent for audits and inspections to protect subject confidentiality while ensuring data integrity.

"The ICF must include a statement allowing access to trial data for monitoring, auditing, and regulatory inspection purposes."

Objectives:

Ensure informed consent for data access.

Facilitate compliance with auditing requirements.