Before conducting an audit, the auditor (including the auditing department manager) should establish a written audit plan (such as an annual plan, a monthly plan, and a plan specific to each trial or audit) based on the results of the risk assessment according to the written auditing procedures.
5.1 Establishing the Goals of Audits
One or more objectives are generally established for a trial audit based on the importance of the trial with regard to submissions to regulatory authorities, the type and complexity of the trial, the level of risk to the trial, and any problem(s) identified previous. The most important part of audit planning is to specify the goal(s) of the audit. By establishing the goal(s) of an audit, the subjects and methods of the audit will be determined and the consistent conduct of the audit will be ensured. One or more objectives may be chosen from the following examples:
• Evaluation of the compliance of any organization involved in a clinical trial (pre-qualification).
• Evaluation of the compliance with regulatory requirements and human subject protection.
• Confirmation of the appropriate conduct of a trial, the credibility of data obtained, and the condition of record keeping at a participating medical institution(s) through direct access.
• Confirmation of the conduct of monitoring.
• Confirmation of the credibility of a clinical trial/study report.
• Early detection and collection and prevention of any existing problems or potential problems with a system and/or process.
• Early detection and collection and prevention of any existing problems or potential problems occurring at an institution entrusted with trial-related duties.
5.2 Designing and Updating the Audit Plan
Planning is essential to systematically- effectively, and efficiently conduct an audit with consideration of resource management in the auditing department. Audit plans, such as an annual plan, a monthly plan, and a plan specific to each trial or audit, should be established based on consideration of the goal(s), contents (e.g.subjects and methods), and timing of an audit, the progress of the targeted trial, and other relevant factors. The audit plan should be updated in accordance with progress of the trial or auditing activity. Prior to conducting an audit, the auditors and the auditee will discuss and adapt the audit plan, as necessary.
5.3 Determining the Subject[s], Timing, and Method[s] of an Audit
The subject(s) (e.g., a medical institution. CRO, system, clinical trial/study report, computerized system validation, and database), timing (e.g., before the start of the trial, during the trial, after the completion of the trial, or periodically), and the method(s) (e.g., sampling, interview, or tour) of an audit should be determined based on the goal(s) established for the audit.
5.4 Information in the Audit Plan
An audit plan should provide the following information, although the contents may vary depending on the type of the plan (e.g., annual plan, monthly plan, or plan for a specific trial or audit).
• The goal(s) of the audit.
• The subject(s) of the audit.
• The scope of the audit.
• The timing of the audit.
• The name(s), title and address of the auditor (s)(and the auditing department manager).
• The reference documents required.
• The person(s) to whom the audit report will be submitted.
• Timelines for the audit(s) and report(s) (if possible)