E6: Audit

Question 1

5.19 - Audit

If or when sponsors perform audits, as part of implementing quality assurance, they should consider:

5.19.1

Purpose:

Answer 1

The purpose of a sponsor’s audit, which is independent of and separate from routine monitoring or quality control functions, should be to evaluate trial conduct and compliance with the protocol, SOPs, GCP, and the applicable regulatory requirements.

Question 2

Audit

5.19.2

Selection and Qualification of Auditors

Answer 2

(a) The sponsor should appoint individuals, who are independent of the clinical trials/systems, to conduct audits.

(b) The sponsor should ensure that the auditors are qualified by training and experience to conduct audits properly. An auditor’s qualifications should be documented.

Question 3

Audit

5.19.3

Auditing Procedures

Answer 3

(a) The sponsor should ensure that the auditing of clinical trials/systems is conducted in accordance with the sponsor’s written procedures on what to audit, how to audit, the frequency of audits, and the form and content of audit reports.

(b) The sponsor’s audit plan and procedures for a trial audit should be guided by the importance of the trial to submissions to regulatory authorities, the number of subjects in the trial, the type and complexity of the trial, the level of risks to the trial subjects, and any identified problem(s).

(c) The observations and findings of the auditor(s) should be documented.

(d) To preserve the independence and value of the audit function, the
regulatory authority(ies) should not routinely request the audit reports. Regulatory authority(ies) may seek access to an audit report on a case by case basis when evidence of serious GCP non-compliance exists, or in the course of legal proceedings.

(e) When required by applicable law or regulation, the sponsor should provide an audit certificate.