Principles of Good Clinical Practice

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Principles of Good Clinical Practice

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Principles of Good Clinical Practice

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Michael J McGraw, Adam N George, Shawn P Shearn, Rigel L Hall and Thomas F Haws Jr (eds)
Published by
Pharmaceutical Press
Publication Date
July 2010
272 pages
256 x 234 mm

Principles of Good Clinical Practice is a one-stop source for guidance and rules for proper conduct of clinical trials. The book also provides a historical perspective of the clinical research landscape.

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.

This book 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 a definitive text for clinical development personnel at pharmaceutical companies, Contract Research Organizations (CROs), PharmD and postgraduate pharmacy students, and medical, pharmacy and drug company libraries. 
  1. Introduction to Good Clinical Practice
  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

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