Archiving Clinical Trial Documents 2nd Edition
Elizabeth Hooper
Archiving and the retention of clinical documents is an area which generates a lot of discussion within the pharmaceutical industry. ICH GCP and the EU directives provide the regulatory framework for clinical trials and set requirements for the retention of clinical trial documents, however, contradictions within the regulations exist. This monograph provides you with guidance with regards to archiving documents and provides you with the necessary template forms that can be used for your archived documents.
Liz Hooper has several years experience working with records management and archiving. She’s also a member of several organisations concerned with clinical research, quality and documentation. She’s widely published in books and journals.
Published 2008.
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Or
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Cost
The cost of one copy is £9.99 postage included. However, for large quantities, simply call 01628 501700 or send an email regarding your enquiry to office@icr-global.org.