Authors: Cynthia McGuire Dunn, M.D. & Gary Chadwick, Pharm.D., MPH, CIP
Protecting Study Volunteers in Research was designed to help organizations provide the highest standards of safe and ethical treatment of study volunteers. Protecting Study Volunteers in Research addresses current and emerging issues that are critical to our system of human subject protection. This manual is perfect for clinical research professionals involved in the management and conduct of clinical trials, IRB members actively involved in clinical trials, investigative sites, academic medical centers, sponsors, CROs, SMOs and for academic institutions to provide to their clinical researchers as a reference manual for conducting and managing their clinical trials.
*Readers can apply for 7.5 CME hours or 9.0 nursing contact hours. An exam is provided with each manual and is available online. To earn 7.5 CME hours, participants must earn a score of at least 70% on the exam no later than May 31, 2007. To earn 9.0 nursing contact hours, participants must earn a score of at least 70% on the exam no later than August 1, 2007.
Book features:
- 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
Perfect 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
To preview the Table of Contents and other sample pages, click on the links below:
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*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 7.5 hours in category 1 credits toward the AMA Physician’s Recognition Award. Each physician should claim only those credits that he/she actually spent in the activity.
This activity has also been approved by the New York State Nurses Association’s Council on Continuing Education, which is accredited by the American Nurses Credentialing Center’s Commission on Accreditation, and is assigned approval code 5WSR4D-04. This has been assigned 9.0 contact hours.
