The development and implementation of a quality assurance Master Audit Plan.

As a quality assurance (QA) department for a clinical research organization, QA conducts audit activities for clinical trials managed by our organization and acts as an independent QA group for several other companies. A quality assurance/regulatory compliance Master Audit Plan is developed for each study or each audit if the audit is an independent task. The Master Audit Plan designed for a specific clinical study consists of a combination of several QA activities designed to ensure quality and regulatory compliance, to define timelines, and to identify personnel. These activities may include the review of the regulatory documents for each investigative site prior to the shipping of test article (test article release), review of informed consent, review of internal sponsor study files, and clinical site audits. Results of audit activities conducted under the Master Audit Plan for several clinical studies have been compiled for three of the major QA tasks. These include test article release, informed consent review, and site audits. A review of regulatory document files for test article release indicated that 13% required additional documents or correction of submitted documents. A review of informed consents found that 32% required revision. Site audit activities indicated that the clinical sites were, in general, adhering to Federal regulations and GCP guidelines. Observations noted at sites tended to fall into the categories of test article accountability issues, regulatory document additions or revisions, and quality control issues.