6. Conduct of an Audit

Auditing is performed by the auditor in accordance with a written audit plan and procedures, and involves the examination and evaluation of information obtained through investigation of the audit trail (e.g. essential documents and SOPs) and a trial site(s) (e.g. facilities and equipment), as well as interviews with the auditee, etc. It is important to specify reference documents that auditees comply with before performing an audit so as to ensure fair conduct of audit. The auditor evaluates conformity and compliance with these reference documents. The auditor should inform the sponsor about the conduct of an audit in advance.

6.1 Explaining The Auditing Procedures To efficiently collect accurate information through auditing, the auditor should give the auditee a prior explanation about the conduct of an audit (e.g. the goal(s) and method(s) of the audit). When providing an explanation for the auditee, the auditor should confirm the subject(s) (i.e. materials and facilities that will be audited), the schedule, and the contact person(s) for the audit so that both the parties obtain the necessary and full understanding about the audit. 6.2 Conducting an Audit and Collecting Information There are two types of sponsor's audit, i.e., auditing of internal trial-related department(s) and auditing of external establishment(s) involved in the trial concerned, e.g., a medical institution, laboratory, and/or CRO. To ensure the smooth conduct of an audit of an external institution. such as a participating medical institution, laboratory, or CRO, it is important to properly perform a preliminary internal audit. When conducting an audit, the auditor should collect audit observations by reviewing the documents subject to the audit and interviewing the auditee etc. Based on audit observations collected, the auditor should confirm and document whether or not the audit observations are compliant to GCP, all applicable regulatory requirement(s), SOPs, the study protocol, and any other relevant documents and procedures. Utilization of an audit checklist and a sampling method is useful for the standardization and efficient conduct of auditing activities.

6.3 Confirmation and Evaluation of Audit Observations The auditor should discuss audit observations with the auditee so that the absence of errors can be confirmed. The auditor should then review the confirmed audit observations and further information can be collected if required. The auditor should examine (within the auditing department) whether the audit observations involve any violations of GCP or applicable regulatory requirements, deviations from the relevant protocol and sponsor's SOPs. or problems with respect to the reliability of clinical data and then should determine the observations to be reported as audit findings. The auditor should also examine whether any of the obtained audit observations could have an influence on other trials, medical institutions, clinical trial/study systems, etc. When audit findings are reported, they may be graded according to the level of importance.