There are two types of audits in research;  routine audits and for-cause audits.

 

Routine audits are often performed by the IRB, Sponsor, FDA or internally.

The goal of an audit is to review and verify the ethical conduct of research for human participants, to see if the study protocol was followed, check the integrity of the data and the state and federal regulations.  Most audits review the informed consent, the consent process, regulatory documents, source documents to ensure protocol compliance and drug accountability records. The internal auditor may want to review the site’s SOPs and the research team’s credentials and documentation of training.

 

For-cause audits may be conducted during the monitoring process if a Sponsor has continued documentation of possible noncompliance and concerns over the ethical conduct of the study by the P.I.

The Sponsor may contact the FDA and report these concerns which could result in a for-cause

FDA audit.  Research participants could also report to the FDA their concerns and this could also result in an FDA for-cause audit.

 

The IRB and the Sponsor can also perform a for-cause audit.  Items reviewed in a for-cause audit are very similar to those reviewed in a routine audit.

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HHS 45 CFR 46 Protection of Human Subject, please CLICK HERE.

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FDA E6(R2) Good Clinical Practice: Integrated Addendum to ICH E6(R1) Guidance for Industry, please CLICK HERE.

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FDA 21 CFR 50 Protection of Human Subjects, please CLICK HERE.