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Table Of Contents

Preamble
Introduction
Overview of the clinical research process
WHO Principles of GCP
PRINCIPLE 1: ETHICAL CONDUCT
PRINCIPLE 2: PROTOCOL
PRINCIPLE 3: RISK IDENTIFICATION
PRINCIPLE 4: BENEFIT-RISK ASSESSMENT
PRINCIPLE 6: PROTOCOL COMPLIANCE
PRINCIPLE 7: INFORMED CONSENT
PRINCIPLE 9: INVESTIGATOR QUALIFICATIONS
PRINCIPLE 10: STAFF QUALIFICATIONS
PRINCIPLE 11: RECORDS
PRINCIPLE 12: CONFIDENTIALITY/PRIVACY
PRINCIPLE 13: GOOD MANUFACTURING PRACTICE
PRINCIPLE 14: QUALITY SYSTEMS
References
Other documents cited in the Handbook
Related documents
National good clinical practice and other guidelines
Acknowledgements
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WHOHandbookonGCP04-06

WHOHandbookonGCP04-06

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Published by: crispinner on Jan 11, 2012
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