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.

Product Details

• Amazon Sales Rank: #106291 in Books
• Published on: 2008-04-01
• Original language: English
• Number of items: 1
• Binding: Paperback
• 454 pages

Review
Karen and JC have done a fabulous job of presenting the entire spectrum of CRA responsibilities on a very concise and understandable format. It's the best CRA book I've seen to date, and I've seen many. I wish I had had this book when I started monitoring. --Joann C. Phillips, R.N., Former President, ACRP; Senior Program Manager, Clinimetrics Research Associates

Customer Reviews

Excelent purchase
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.

Very practical, great info
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.

Good Resource for CRAs
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.