Clinical trials audit preparation: a guide for good clinical practice (GCP) inspections
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Bibliographic Details
Main Author: Mihajlovic-Madzarevic, Vera (Author)
Format: Electronic eBook
Language:English
Published: Hoboken, N.J. Wiley c2010
Subjects:
Online Access:FRO01
FUBA2
UBG01
Volltext
Item Description:Includes bibliographical references and index
A must-have guide for any professional in the drug manufacturing industry. The Good Clinical Practice (GCP) audit is a tedious but necessary exercise that assures that all parties do their job properly and in compliance with the applicable FDA code. Clinical Trials Audit Preparation demystifies the audit process for all parties involved, including clinical research sponsors, clinical investigators, and institutional review boards. This book provides a step-by-step explanation of the FDA audit procedures for clinical trials and of how pharmaceutical companies, clinical investigators, and instit
Physical Description:1 Online-Ressource (xxi, 246 p.)
ISBN:9780470572757
0470572752
9780470572740
0470572744
9780470920886
0470920882

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