Good Clinical Practice

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. The second edition has been produced to reflect changes in regulations since then, and to address feedback received on the first version. The guidance and advice contained within this document are consistent with the requirements of EU Commission Clinical Trial Directive 2001/20/EC and supporting Directives, UK SI 1928:2006, US 21 CFR312 and ICH GCP Guidelines.

Good Clinical Practice - A Guide to Archiving Page 5 3 Roles and Responsibilities 3.1 Sponsor Prior to initiating a trial the Sponsor should define, establish and allocate all trial related duties and functions. In relation to material retention, the Sponsor should: Agree the format in which all records will be maintained

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