Study Monitoring/Audits

DEFINITION

• Study Monitoring includes reviewing the data and regulatory records to ensure that data is captured as planned and that study personnel are meeting regulatory responsibilities.
• Audits, in addition to inspections or study monitoring visits, are a step in the study monitoring process to ensure that studies are conducted compliantly. Audits may be performed internally or externally by Institutional Review Boards (IRBs), monitors, sponsors, or other regulatory agencies.

Policies/Guidelines

External Monitoring

• Sponsor-initiated studies, and even some investigator-initiated studies funded by external sources, necessitate study monitoring visits.
  • Even if the study does not have external monitoring, it is good practice to periodically review the data and regulatory records to ensure compliance.
• The Human Research Protection Program, Office of Integrity and Compliance (OIC), Office of General Counsel, relevant division/department chairs, and Investigational Drug Service (if applicable) should be notified of upcoming audits or inspections of research studies, whether the study is reviewed by the UMMC IRB or an external IRB on UMMC’s behalf. Such notification should occur immediately upon learning of such audit or inspection.
• UMMC Protocol for External Auditors

Remote Monitoring and Visits

• Monitoring visit may be done in-person or remotely.
• Remote monitoring are permissible but must be conducted in accordance with UMMC policies. See the Guidance for Remote Monitoring and Visits.

UMMC Audits

• The UMMC OIC is responsible for conducting post-approval directed (“for cause”) audits and periodic (not “for cause”) compliance audits of human subjects research conducted under the auspices of UMMC.