A sponsor's audit should be independent of and separate from routine monitoring or quality control functions. The purpose of auditing is to evaluate trial conduct and compliance with the protocol, SOPs, this Regulations, and the applicable regulatory requirements.

Selection and qualification of auditors should comply with:
1.The sponsor should appoint individuals, who are independent of the clinical trials and data capture systems, to conduct audits.
2.The sponsor should ensure that the auditors are qualified by training and experience to conduct audits properly. An auditor’s qualifications should be documented.

The auditing procedures should comply with:
1.The auditing procedures 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.
2.The sponsor's audit plan and procedures for a trial audit should be guided by the importance of the trial, 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).
3.The observations and findings of the auditor(s) should be documented in writing.
4.To preserve the independence and value of the audit function, the Competent Authority should not routinely request the audit reports, except when evidence of serious non-compliance with this Regulations exists, or in the course of legal proceedings, the Competent Authority may seek access to an audit report on a case by case basis.
5.The sponsor should provide an audit certificate.