Product Description

The CRA's Guide to Monitoring Clinical Research is a comprehensive and practical educational resource for both the novice and experienced CRA. This newly updated training tool provides essential information on the clinical research process, regulations, role responsibilities, helpful hints and personal experiences. This guide also teaches CRAs to demonstrate how regulations, GCPs and SOPs can be applied to everyday operations of conducting and monitoring clinical trials.

Topics covered include:
*The history behind the regulations
*Clinical study preparation
*The informed consent process
*Adverse events and safety monitoring
*Recruitment, retention and compliance of study subjects
*Errors, misconduct and fraud
*The future of CRAs and more

The CRA's Guide to Monitoring Clinical Research is also recommended for CROs, clinical trial sponsors and investigative sites conducting group or staff training programs.

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Product Details

Publisher	CenterWatch, a division of Jobson Medical Information LLC
ISBN	1930624557
Creator	Sara Gambrill Steve Zisson
Author	Karen E. Woodin,Ph.D.,John C. Schneider
Format	Paperback
Label	CenterWatch, a division of Jobson Medical Information LLC
Edition	Second
Dewey Decimal Number	616
Studio	CenterWatch, a division of Jobson Medical Information LLC
EAN	9781930624559
Number Of Pages	454
Title	The CRA's Guide to Monitoring Clinical Research :2nd Edition
Publication Date	2008-04-01
Manufacturer	CenterWatch, a division of Jobson Medical Information LLC

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Customer Reviews

Great resource for students and new monitors!

Review by Carrie Catanzaro, 2010-07-12

I bought this book for a Monitoring class I'm taking at George Washington University. It wasn't a required text, but I'm finding it very useful and full of just enough to be helpful - without bogging me down with too much info. All the relevant CFR sections are here too which is a handy reference.

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Good Resource for CRAs

Review by Stefan Schuber, 2009-03-05

First, I have to say that although I have worked in the pharma industry for many years, I have never worked at a CRA. Because of this gap in my experience I found the Guide to Monitoring Clinical Research refreshingly honest and detailed. Second, the book presents sufficient detail that I feel I benefited from reading it. Finally, depending on your level of expertise you can decide if this is a worthy addition to your library.

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How the heck can you NOT include an index in a book like this??

Review by mango, 2008-08-01

as a project manager who supports rhe functions of (but doesn't actually do) clinical monitoring research, i thought this would be a great resource book to keep on-hand when various terms or concepts came up that i wanted to get more information about. however, i was extremely disappointed to flip to the back few pages, only to discover that the last section was "about the authors" rather than an index. it should go without saying that this kind of book needs an index - for new CRAs, as well as for people like me who have only minimal exposure to monitoring but need to understand it. what were the authors thinking?? i'm sure it's a good book and it seems chock full of information... but i'm looking for something i can thumb through and find exactly the term or concept i need without having to hunt for it. i'm sending this back and looking for another book that does include an index. if anyone has recommendations, i'm all ears! (and no, my shift key isn't broken... i just never use caps except for acronyms and formal documents.)

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Very practical, great info

Review by San Francisco Citizen, 2007-07-03

This and the CRC Guide put a wealth of information at my fingertips when I was a "newbie" to clinical research and needed something practical I could sink my teeth into without feeling like I'd jumped in over my head.

I still refer to these every couple of months for a refresher on best practices.

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Excelent purchase

Review by Sergio Ariel Godoy, 2007-01-10

This is a perfect book for a CRA who has just starting working in the field of research. Not only the most important topics that a CRA must know are provided in this book but also it has a very complete Appendix with "hind and tips", resources, sample forms and guidelines.

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