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University of Pittsburgh

Activities and Services

Directed/For-Cause Audits

Directed or For-Cause audits are conducted by the ECO-HSR staff at the request of the IRB or in response to a complaint from an employee or subject regarding the conduct of the study. The IRB may request an audit after identifying concerns with the study during committee review of a modification or renewal submission. Multiple submissions of unanticipated problems may also trigger this type of audit. The IRB Chair, IRB Director, or any member of a convened IRB committee may direct the ECO-HSR staff to perform an audit of any protocol conducted under the jurisdiction of the University of Pittsburgh IRB.

In addition, when a PI is notified of a pending FDA inspection on a specific protocol, the investigator is required to notify the IRB. If time permits, the staff of the ECO-HSR may assist the investigator and the research coordinator by reviewing study records in preparation for the FDA audit.

The ECO-HSR staff contacts the principal investigator and study coordinator to arrange for a suitable date and time (usually within two weeks of the IRB directive). During the audit, the ECO-HSR staff reviews regulatory documentation, subject records including consent document, lab results (if applicable), test results as they pertain to the research, unanticipated problems and adverse events. Adherence to the IRB approved protocol is evaluated including the schedule of activities, procedures, and study visits.

The reason for the audit dictates what records are reviewed. For a full audit, the number of subjects’ records reviewed is typically limited to 20-25 percent of the total enrollment but may include review of 100 percent of the records. This decision is made on a case-by-case basis and may change as the audit progresses based on the findings.

A report of the audit findings is forwarded to the principal investigator, department chair and the IRB Executive Committee. The investigator is given an opportunity to respond to the findings. All further correspondence, decisions or sanctions emanate from the IRB.