{
"item_title" : "GCP - A Guide to Archiving",
"item_author" : [" Chris Jones "],
"item_description" : "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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Overview
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).
This item is Non-Returnable
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Details
- ISBN-13: 9780955765940
- ISBN-10: 0955765943
- Publisher: Scientific Archivists Group Limited
- Publish Date: July 2014
- Dimensions: 9 x 6 x 0.13 inches
- Shipping Weight: 0.2 pounds
- Page Count: 54
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