Principles of Good Clinical Practice
McGraw, Michael J; George, Adam N; Shearn, Shawn P; Hall, Rigel L; Haws, Jr, Thomas F
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
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 also available as an eBook.
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- ISBN 978 0 85369 790 9
- Published Jul 2010
234 x 156mm (272pp)