Monitoring and Audit Visits Standard Practice Guidelines

Guide to optimize clinical trial oversight with vigilant protocol adherence and compliance, prepared for any sponsor, university, or regulatory audits

What is this resource?

Investigators are responsible for ongoing oversight of clinical trials for adherence to the protocol and compliance with regulatory obligations. This may include monitoring the progress and quality of the trial. In addition, a clinical research site may be audited by the University of Michigan, the clinical trial sponsor or a regulatory agency.

Sponsors may require clinical trials to be managed following the International Council on Harmonisation Good Clinical Practices (ICH GCPs). In conformance with ICH GCPs, clinical trial monitoring services should be provided by qualified personnel.

Monitoring processes or guidelines should include the following details related to site monitoring and audit visits:

• Identify personnel involved, and prepare them for the visit/audit
• Allocate work space, equipment, and time to meet with the monitor/auditor
• Provide sign-in procedures
• Ensure appropriate communication occurs prior to and following monitoring and audit visit

MICHR’s Clinical Study Monitoring team is available to support research teams.

How this advances translational science

Implementing operations that facilitate and support the quality and impact of research.