Protecting study volunteers in research: a manual for investigative sites

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CenterWatch, 1999 - Medical - 234 pages
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Recommended by the National Institutes of Health, the Office of Health and Human Services and the FDA, Protecting Study Volunteers in Research is a 250-page manual designed to assist clinical research professionals in providing the highest standards of safety and ethical treatment for their study volunteers. This convenient and portable manual has become required reading in academic institutions, IRBs and independent investigative sites. Many sponsor and CRO companies have also made this manual mandatory reading for their staff and service providers. Developed in accordance with the essentials and standards of the ACCME, readers can apply for CME credits or Nursing Credit Hours. An exam is provided with each manual. pics include... Historical perspectives on human subject research; Ethics and federal regulations; Roles and responsibilities of institutions and independent sites; Roles and responsibilities of investigators and study staff.

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Contents

Conclusion
13
The Roles and Responsibilities of Institutions in Human Subject Research
33
Study Process
46
Copyright

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