The CRA's Guide to Monitoring Clinical Research [Paperback]

Karen E. Woodin (Author), John C. Schneider (Author)

Book Description

Publication Date: January 1, 2003 | ISBN-10: 1930624379 | ISBN-13: 978-1930624375 | Edition: 1st

The CRA's Guide to Monitoring Clinical Research is a valuable and practical educational resource for the individual readers and for group and staff training programs. Written by Karen E. Woodin, Ph.D., and John C. Schneider, this 400+ page CE-accredited book is an ideal resource for novice and experienced CRAs, as well as professionals interested in pursuing a career as study monitors.

The CRA's Guide explains the role and responsibilities of a CRA, informs readers of the history of the regulations, explains in detail the research process and describes the regulations and GCPs that govern clinical research.

Book topics:

- Preparing for a study and selecting investigators
- Obtaining and monitoring informed consent
- Preparing for a monitoring visit
- Recruiting and retaining study subjects
- Conducting adverse event and safety monitoring
- Preparing for audits and detecting fraud

Editorial Reviews

Review

A fabulous job of presenting the entire spectrum of CRA responsibilities in a very concise and understandable format. -- Joann C. Phillips, R.N., Former President, ACRP, Senior Program Manager, Clinimetrics Research Associates

Product Details

• Paperback: 448 pages
• Publisher: Centerwatch; 1st edition (January 1, 2003)
• Language: English
• ISBN-10: 1930624379
• ISBN-13: 978-1930624375
• Product Dimensions: 8.8 x 6 x 1 inches
• Shipping Weight: 1.6 pounds
• Average Customer Review: 4.6 out of 5 stars  See all reviews (5 customer reviews)
• Amazon Best Sellers Rank: #366,331 in Books (See Top 100 in Books)

Customer Reviews

Most Helpful Customer Reviews

8 of 9 people found the following review helpful:

5.0 out of 5 stars Excelent purchase, January 10, 2007

By 

Sergio Ariel Godoy (Buenos Aires, Argentina) - See all my reviews
(REAL NAME)   

This review is from: The CRA's Guide to Monitoring Clinical Research (Paperback)

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.

4 of 4 people found the following review helpful:

5.0 out of 5 stars Very practical, great info, July 3, 2007

By 

Oakland Citizen "Oakland Citizen" (Oakland, CA, USA) - See all my reviews

Amazon Verified Purchase

This review is from: The CRA's Guide to Monitoring Clinical Research (Paperback)

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.

5 of 6 people found the following review helpful:

3.0 out of 5 stars How the heck can you NOT include an index in a book like this??, August 1, 2008

By 

mango "mango" (metro nyc area) - See all my reviews

Amazon Verified Purchase

This review is from: The CRA's Guide to Monitoring Clinical Research (Paperback)

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.)