Good Clinical Practice

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good Clinical Practice - A Guide to Archiving 2nd Edition July 2014 Foreword One of the fundamental requirements of the principles of good Clinical Practice (GCP) is the need to ensure the integrity and secure retention of Clinical trial documents for a period of time determined by legal, regulatory and business requirements. Essential Documents serve to demonstrate the compliance of the investigator, sponsor, and monitor with the standards of GCP and with all applicable regulatory requirements. The first version of this guidance was published in 2007.

One of the fundamental requirements of the principles of Good Clinical Practice (GCP) is the need to ensure the integrity and secure retention of clinical tria l documents for a period of time determined by legal, regulatory and business requirements. ... ICH E6 Section 3.4 states the EC/IRB should retain all relevant

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