Conclusion

The results of this survey show a uniform process for conducting investigator site audits and reporting audit findings:

• Audits are typically performed according to global standards and procedures. A majority of companies also use global tools to support the audit process.
• Audit findings are assigned to categories according to their contents. The categories used are similar across companies.
• Audit findings are also assessed and classified according to significance, normally by indicating whether they are critical, major, or minor.
• Audit reports undergo internal quality control before being issued, usually by conducting peer review within QA.
• Reports are then issued in two steps: first as a draft or initial report to obtain responses and then as a final report.
• Most companies define timelines for both issuing the audit report and responding to it, allowing more time for responses.

Regarding the consequences and utilization of audit findings in a broader, quality-management framework, the results are less consistent across companies.

• While a majority of companies send the initial audit report to the direct auditees for responses, about half of them also involve line or functional management in the response process—including the implementation of corrective action. In a minority of companies, the responsibility of responding lies with management only.
• Except for the fact that critical audit findings are reported internally within the company in an expedited manner, no consistent pattern appeared in the handling of critical audit findings (e.g., whether agencies and ethics committees are notified or whether such findings are included in the clinical study report). Our results cannot determine whether this is due to differing practices across companies or whether such findings are handled on a case-by-case basis.
• Although a majority of companies perform some form of trend analysis of audit findings, the details of such analyses vary considerably as to how they are performed and to whom the results are presented. However, about 80% conduct trend analysis across all audits, and nearly all companies communicate trending results to senior management.
• Finally, we obtained no uniform pattern regarding the use of audit findings in formal quality programs such as the implementation and tracking of key performance indicators. However, 70% of all companies stated that they use trending results for process improvement.