Best Practice for Clinical Monitoring

July 1, 2011
Lisa Henderson

Lisa Henderson is Editor-in-Chief of Applied Clinical Trials and Pharm Exec. She can be reached at lhenderson@mmhgroup.com.

Applied Clinical Trials

Applied Clinical Trials, Applied Clinical Trials-07-01-2011, Volume 20, Issue 7

Our book review for the latest industry guidebook for monitors.

Author Gerald Van Roey has over 10 years of experience as a clinical monitor. His book offers sharp insights for both the new and experienced monitor.

After the first chapter primer about clinical research, Van Roey delves into the more granular areas of the practice of clinical monitoring. For that, the best chapter is Chapter 2. It looks at the qualities that make a good monitor and the relationship with an investigator.

Clinical Monitoring

Chapter 7 offers the reader a good grasp of initiation visits and tips on how to approach the study personnel.

Chapter 8, titled Monitoring Visits, is a large part of the book and takes on a lot. There is discussion about the import and export of clinical supplies, IMP distribution, tracking, and return of used IMP, which is very interesting and something with which I didn't have a lot of knowledge, and found very helpful.

Sections on site management, recruitment issues, the right protocol, and site selection included good information, but maybe not so related to the function of monitoring. Subject recruitment is a very complex area of clinical trials. It requires many initiatives that all fire on the same cylinders to ensure rapid and inclusive enrollment. The chapter offers several good ideas such as the monitor playing a part in communicating protocol information to the site, pinpointing problem areas, and suggesting solutions. But the section seems geared to the pharmaceutical company, or the CROs function.

Overall, the book is well written, with a pleasing design. It offers excellent tips, drawing these out in colored boxes to help the reader.

The book is available from the publisher PharmImage, www.PharmImage.com, and costs €39.95, or approximately $56.

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