Planning Of Audits
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:
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