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Principles of Good Clinical Practice
McGraw, Michael J; George, Adam N; Shearn, Shawn P; Hall, Rigel L; Haws, Jr, Thomas F
First edition
Edited by Michael J McGraw - Senior Manager, Regulatory Affairs, Teva Neuroscience, Inc, USA; Adam N George - Medical Information Manager, Cephalon Inc, USA; Shawn P Shearn, Rigel L Hall and Thomas F Haws, Jr, GlaxoSmithKline, USA
Good Clinical Practice guidelines provide an international quality standard for the regulation of clinical trials. They include standards on how clinical trials should be conducted, provide assurance of safety and efficacy of newly developed drugs and protect human rights.
Principles of Good Clinical Practice describes the ethical principles and regulatory requirements that influence the current and future conduct of clinical research. As well as providing essential information on clinical trial design and pharmacovigilance, coverage also includes:
- informed consent
- investigator and sponsor responsibilities
- site monitoring
- institutional review boards and independent ethics committees
- clinical trial registration and reporting
- quality assurance
- future implications for good clinical practices.
Principles of Good Clinical Practice is also available as an eBook.
2. Regulatory Requirements
3. Informed consent
4. Investigator responsibilities
5. Sponsor responsibilities
6. Clinical Trial Design
7. Site monitoring
8. Institutional Review Boards and Independent Ethics Committees
9. Pharmacovigilance
10. Clinical trial registration and reporting
11. Quality assurance
12. Future Implications of Good Clinical Practice
Sample chapter (241 KB)Jul-2011, Journal of Clinical Research Best Practices
Selected for "The First Clinical Research Bookshelf" - Essential reading for clinical research professionals.
" a readable introductory summary of Good Clinical Practice (GCP) for pharmaceutical studies based on U.S. regulations and ICH E6 guidelines, which FDA has adopted as guidance...the book strikes a good balance between too much and too little detail"
Norman M. Goldfarb, Journal of Clinical Research Best Practices Vol. 7(7), July 2011
01-Nov-10, Doody's Notes
'...details requirements and discusses ethics surrounding clinical investigational trials. This is a worthy topic and relevant to pharmacy practice...an appropriate book for someone new to research, interested in doing research, or in an academic environment.'
Barbara Lane Giacomelli, PharmD, MBA, BS, FASHP (Shore Memorial Hospital) Doody's Notes, November 2010
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