Bioequivalence and Bioavailability Forum

Dear VASU,
The In-Trial Audit Plan's objective is to determine compliance with approved procedures. These approved procedures include internal procedures, contracts, and government and state regulations.

The audit plan will specify the number of audits to be conducted, the days audit will occur, and the name of the individual who will conduct the audit. This part of the planning process is conducted in conjunction with your clinical research department management. You work your audit schedule around their schedule to minimize personnel conflicts and ensure the clinical trial run smoothly. The audit plan is agreed to by the auditee (Say, QA) and may change throughout the year. Therefore, it is clearly stated that dates and times are subject to change.

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Edit: Full quote removed. Please delete anything from the text of the original poster which is not necessary in understanding your answer; see also this post! [Helmut]