Audits & Inspections

To provide assistance to Principal Investigators (PIs) and Research Administrators who are contacted by sponsors, regulatory agencies or external auditors about an audit, investigation, or review, Mass General Brigham has implemented a Coordination of External Audits Policy and Standard Operating Procedures (SOP). The policy identifies an entity-based “Designated Official” (DO) for each area of research who serves as liaison to the auditor or regulatory agency; works with the PI or Research Administrator to identify materials for review; and informs and communicates with relevant hospital and MGB senior leadership throughout the audit or review.

IF YOU ARE A PI/RESEARCH ADMINISTRATOR WHO RECEIVED NOTIFICATION OF AN AUDIT:

Immediately forward the notification to the appropriate DO, and work with the DO until the conclusion of the audit or review. Files or other materials should not be turned over to the auditor or reviewer until they have been reviewed by the DO.

IF YOU ARE A DESIGNATED OFFICIAL WHO HAS BEEN CONTACTED DIRECTLY ABOUT AN AUDIT

Notify Mass General Brigham Research Compliance and report the audit notification to the other appropriate parties in accordance with the Communication Grid listed in the Audit Coordination Policy SOP. Follow the additional steps in the audit process provided in the SOP.

Questions relating to the policy, SOP or audits should be sent to the Mass General Brigham Research Compliance Office or to your hospital’s Research Compliance Office.