University of Rochester

Study Self Audit Tools

These audit tools were created for study sites interested performing self-audits of their research projects. The objective is to provide easy to use audit checklists that follow the basic principles and procedures of a quality improvement audit as one would expect from an internal or external auditor.

There are two main components of any Good Clinical Practice (GCP) study audit, review of the regulatory documents (study documentation) and review of compliance to the protocol (individual subject data accuracy). Checklists for these two components are provided along with instructions and examples of how a completed checklist may look.

The most frequently observed findings by auditors, are associated with the informed consent form. The individual subject data accuracy checklists covers the consent form compliance, i.e., was the correct version used, was consent obtained before study entry? For studies that enroll a large number of subjects, it may not be practical to complete a subject data accuracy checklist for every enrolled subject; a predetermined sample number can be used in these cases. Because compliance with proper informed consent documentation has been shown to be an area of concern, a study consent form review checklist has been provided. This checklist can be used to check for consent form compliance for every subject who has signed a consent form.

The Study Selection

A study site may want to audit a specific study for a variety of reasons, e.g., planned sponsor audit, change in investigator or coordinator, or compliance concerns. A site may want to randomly pick a study to evaluate compliance to GCPs and how they would fare if an audit was done at their site.

When selecting a study to audit, try to keep the following points in mind in order to get a better overview of the study conduct:

Have an adequate number of subjects been enrolled so that a review would be meaningful?

Have there been any amendments? (Amendments may affect subject eligibility or require additional procedures or change in personnel resulting in a revised consent form.)

Has there been an IRB progress report submitted? (Longer running studies may yield more information.)

Has there been a change in site personnel involved in the study?

The Audit Process
Download the checklist(s) you want to use. Review the completed sample checklists provided. Enter the study specific information required on the checklists. Determine the number of subjects you want to audit. Randomly select subjects if not auditing all subjects enrolled.

The Audit Review
At the completion of the self-audit, the site staff should have a good idea of how they would fare if they were audited by an outside entity. If there are repeated findings in specific areas of GCP compliance, corrective actions should be undertaken. Examples of these actions could include additional staff training, or developing of or improving on existing site policies and procedures. In some cases a "note to file" should be inserted in the study documentation to explain what happened.

Audit Finding Reporting
The study self-audit program was designed to allow study sites to complete an assessment of their compliance to GCPs. A component of GCPs is the site reporting requirements to the IRB. Two of the reporting requirements are:

If during the audit review any incidences of reportable events are discovered that have not previously been reported to the IRB, should be reported promptly.

Questions?

If at any point in the audit process there are any questions; from setting up your checklists or requests for consultations during or after the audit, please contact:

Bill Kelvie
Email: bill_kelvie@urmc.rochester.edu
Phone: 275-5244

Checklists to download