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

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

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
http://library.link/vocab/creatorName
Mihajlovic-Madzarevic, Vera
Dewey number
615.5/80724
Illustrations
illustrations
Index
index present
Literary form
non fiction
Nature of contents
  • dictionaries
  • bibliography
http://library.link/vocab/subjectName
  • Drugs
  • Medical audit
  • Clinical Trials as Topic
  • Guideline Adherence
  • Management Audit
  • Quality Control
Label
Clinical trials audit preparation : a guide for good clinical practice (GCP) inspections, Vera Mihajlovic-Madzarevic, (electronic resource)
Instantiates
Publication
Bibliography note
Includes bibliographical references and index
Color
mixed
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 p.)
Form of item
online
Isbn
9780470920886
Isbn Type
(electronic bk.)
Note
Wiley
Other control number
  • 10.1002/9780470572757
  • 9786613024848
Other physical details
ill
Specific material designation
remote
System control number
(OCoLC)654804300
Label
Clinical trials audit preparation : a guide for good clinical practice (GCP) inspections, Vera Mihajlovic-Madzarevic, (electronic resource)
Publication
Bibliography note
Includes bibliographical references and index
Color
mixed
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 p.)
Form of item
online
Isbn
9780470920886
Isbn Type
(electronic bk.)
Note
Wiley
Other control number
  • 10.1002/9780470572757
  • 9786613024848
Other physical details
ill
Specific material designation
remote
System control number
(OCoLC)654804300

Library Locations

    • InternetBorrow it
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