The Resource Clinical trials audit preparation : a guide for good clinical practice (GCP) inspections, Vera Mihajlovic-Madzarevic

Clinical trials audit preparation : a guide for good clinical practice (GCP) inspections, Vera Mihajlovic-Madzarevic

Label
Clinical trials audit preparation : a guide for good clinical practice (GCP) inspections
Title
Clinical trials audit preparation
Title remainder
a guide for good clinical practice (GCP) inspections
Statement of responsibility
Vera Mihajlovic-Madzarevic
Creator
Subject
Language
eng
Summary
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
Cataloging source
DG1
Dewey number
615.5/80724
Illustrations
illustrations
Index
index present
LC call number
RM301.27
LC item number
.M54 2010
Literary form
non fiction
Nature of contents
  • dictionaries
  • bibliography
Label
Clinical trials audit preparation : a guide for good clinical practice (GCP) inspections, Vera Mihajlovic-Madzarevic
Publication
Bibliography note
Includes bibliographical references and index
http://library.link/vocab/branchCode
  • net
Carrier category
online resource
Carrier category code
cr
Carrier MARC source
rdacarrier
Color
mixed
Content category
text
Content type code
txt
Content type MARC source
rdacontent
Contents
Good clinical practice and therapeutic product development -- Therapeutic products clinical development in the United States -- The inspection preparation -- Analysis of warning letters -- Fraud and misconduct in clinical research -- Appendix A: some answers to the most problematic questions in compliance -- Appendix B: guidance for industry--E6 good clinical practice: consolidated guidance -- Appendix C: World Medical Association declaration of Helsinki ethical principles for medical research involving human subjects -- Appendix D: Nuremberg Code -- Appendix E: the Belmont report: ethical principles and guidelines for the protection of human subjects of research
Control code
ocn654804300
Dimensions
unknown
Extent
1 online resource (xxi, 246 pages)
Form of item
online
Isbn
9780470572740
Media category
computer
Media MARC source
rdamedia
Media type code
c
Other control number
  • 10.1002/9780470572757
  • 9786613024848
Other physical details
illustrations
http://library.link/vocab/ext/overdrive/overdriveId
  • 10.1002/9780470572757
  • 9f00b1cc-760b-4c59-a3a7-f2eca2b38cd1
http://library.link/vocab/recordID
.b35723099
Specific material designation
remote
System control number
  • (OCoLC)654804300
  • pebcs0470572744

Library Locations

    • Deakin University Library - Geelong Waurn Ponds CampusBorrow it
      75 Pigdons Road, Waurn Ponds, Victoria, 3216, AU
      -38.195656 144.304955
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