As per ICH-GCP E6 Guidelines, Audit is “A systematic and independent examination of trial related activities and documents to determine whether the evaluated trial related activities were conducted, and the data were recorded, analyzed and accurately reported according to the protocol, sponsor’s standard operating procedures (SOPs), Good Clinical Practice (GCP), and the applicable regulatory requirement(s).”
After any audit, a audit letter or declaration of confirmation is submitted by the auditor that an audit has taken place. Audit is very important for any clinical trial process because it helps to find out and improve the trial process without any objections.
A written evaluation by the sponsor’s auditor of the results of the audit.
Documentation that allows reconstruction of the course of events.