Monitoring a clinical trial is more than simply observing what is going on, it is managing the site to acquire the most accurate possible data. This "how-to" book sets forth the requirements, responsibilities and authority of monitors, teaching proven methods for implementation. For more details consult our catalog.
Contents
Stark NJ, Good Monitoring Practices,
Fourth Edition, Clinical Device Group Inc, Chicago, IL (2004).
340 pages. Perfect bound. ISBN 1-889160-02-4. $250
US
1. The Regulations
2. Qualities of Good Clinical Studies
3. Informed Consent
4. Review Committees
5. Comparison of Monitoring Responsibilities
6. Prestudy Visits: Selecting Investigators
7. Investigator Meetings
8. Study Initiation Visits
9. Monitoring Visits
10. Adverse Events and Effects
11. Close-Out Visits
12. Sponsor Documentation
13. Problem Solving
Glossary
Bibliography
Index