03/08/2015

Laurie Meehan's post to the Quality Systems for Clinical Research Sites LinkedIn group (Link to QSRS) reminds me that it can be confusing for sites how to manage the various types of site audits that occur. Understanding the relationship of an auditor to a research site is so important.

For example, sometimes the audit is sponsor sponsored, sometimes IRB, sometimes from a regulatory authority. In each case there is a plan with a purpose and focus. Also there is an etiquette. When investigator audits are from sponsors, the site may not receive follow-up correspondence or recommendations from the auditor, sometimes they do. This may have to do with the audit plan / focus, the sponsor's SOPs, etc. It is very common the monitor works with their assigned site to verify and respond to sponsor audit findings. The audit may be routine, triggered, narrow focus. Many sites find great benefit from audits, but there are many occasions the communication is poor and the site does not recognize the benefit(s). So, sites should have SOPS for audits that distinguishes regulatory inspection vs. sponsor, self or IRB audit. Important questions for sites to ask prior to the scheduling the audit: 1) why the audit, 2) purpose or plan highlights (e.g., data, compliance, risk assessment, random, etc.), 3) who will be communicating regarding the scheduling, findings, follow-up, answering questions, etc.

Any other thoughts or contributions?