Author: Prof. Dr. med. Peter Altmeyer

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Last updated on: 29.10.2020

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An audit is a review of the implementation of regulations and laws. An audit is part of the quality management of clinical studies and ensures that the protocol and the Standard Operating Procedures (SOP) are carried out in accordance with Good Clinical Practice (GCP). An audit can be performed by the sponsor or by the authorities to ensure the data quality and safety of the study.


Last updated on: 29.10.2020