Protecting Study Volunteers in Research, Third Edition
Authors: Cynthia McGuire Dunn, M.D. & Gary Chadwick, Pharm.D., MPH, CIP
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Protecting Study Volunteers in Research is a comprehensive guide that teaches
organizations how to successfully implement the highest standards of safe and ethical
treatment of study volunteers while addressing current and emerging issues that are critical
to human subject protection.
CME Credits:
*Readers can apply for a maximum of 6.75 AMA PRA Category 1 Credits or nursing contact
hours. An exam is provided with each manual. To earn 6.75 CME hours, participants must earn
a score of at least 85% on the exam no later than May 31, 2013.
Topics include:
- How to comply with the HIPAA Privacy Rule
- Conflict of interest and disclosure
- Participant Recruitment and Retention in Clinical Trials
- Research with Secondary Subjects, Tissue Banks, Repositories,
Databases and Records Review
- Historical perspectives on human subject research
- Updated ethics and federal regulations
- Roles and responsibilities of institutions and independent sites
- Roles and responsibilities of investigators and study staff
Recommended for:
- Clinical research professionals involved in the management and conduct of
clinical trials
- IRB institutions and members actively involved in clinical trials
- Investigative sites and Academic Medical Centers
- Sponsors, CROs, SMOs and academic institutions to provide to their clinical
researchers as a reference manual for conducting and managing their clinical trials
Accreditation:
*The University of Rochester School of Medicine and Dentistry is accredited by the
Accreditation Council for Continuing Medical Education to provide continuing medical
education for physicians.
The University of Rochester School of Medicine and Dentistry designates this educational
activity for a maximum of 6.75 AMA PRA Category 1 Credits. Physicians should only claim
credit commensurate with the extent of their participation in the activity.