Good Monitoring Practices for Medical Devices

Good Monitoring Practices, Fourth Edition (2004)

Stark NJ, Good Monitoring Practices, Fourth Edition, Clinical Device Group Inc, Chicago, IL (2004), 240 pages. Perfect bound, illustrated. ISBN 1-889160-02-4. $250 US

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 consistent with FDA regulations and guidances and ISO 14155 standards. Click for author's notes or to order.

Contents
Introduction—Monitoring Clinical Trials
1. The Regulations
2. "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
Clinical Research Glossary