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GCP - A Guide to Archiving

GCP - A Guide to Archiving

Paperback

General Science

ISBN10: 0955765943
ISBN13: 9780955765940
Publisher: Lightning Source Inc
Published: Jul 16 2014
Pages: 54
Weight: 0.20
Height: 0.13 Width: 6.00 Depth: 9.00
Language: English
This document provides guidance to all organisations (Sponsors and Investigators) that are required to retain and archive records in order to demonstrate compliance with Good Clinical Practice (GCP), and for all organisations that provide contract archive services for both electronic and physical records. Although aimed at GCP regulated organisations, the guidance and advice contained within this document might be of assistance to organisations that retain materials from other types of regulatory work, for example Good Manufacturing Practice (GMP).

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