Handbook of SOPs for Good Clinical Practice [Hardcover]

Celine Clive (Author)

Book Description

Publication Date: February 17, 2004 | ISBN-10: 0849321816 | ISBN-13: 978-0849321818 | Edition: 2

Completely revised and updated, the second edition of a classic reference, Handbook of SOPs for Good Clinical Practice provides templates of SOPs ready for adaptation to your requirements and immediate use. This allows you to create new SOPs or benchmark your existing SOPs against an internationally accepted set of SOPs. The book includes a CD-ROM containing an electronic copy of each of the SOPs and forms in the handbook so that you can easily customize the text to reflect your organization's processes.

The author uses language ranging from the specific to the very general, depending on the activity described and the number of the existing regulations governing the activity. This provides you with a starting point for the development of your organization's SOPs, saving you the time and money that would normally be spent researching and documenting each of the procedures described. Modifying the SOPs supplied by this book will be a much more efficient task than developing new ones from scratch.

Containing templates for SOPs and forms applicable to sponsors, study sites, and Institutional Review Boards (IRBs), Handbook of SOPs for Good Clinical Practice, Second Edition gives you the tools needed to develop effective SOPs for your organization.

Product Details

• Hardcover: 288 pages
• Publisher: Informa Healthcare; 2 edition (February 17, 2004)
• Language: English
• ISBN-10: 0849321816
• ISBN-13: 978-0849321818
• Product Dimensions: 11.1 x 8.8 x 0.9 inches
• Shipping Weight: 1.9 pounds
• Average Customer Review: 5.0 out of 5 stars  See all reviews (1 customer review)
• Amazon Best Sellers Rank: #1,592,736 in Books (See Top 100 in Books)

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Customer Reviews

Most Helpful Customer Reviews

1 of 1 people found the following review helpful:

5.0 out of 5 stars One of a Very Few Fine Books on SOPs, October 5, 2008

By 

Maxim - See all my reviews

This review is from: Handbook of SOPs for Good Clinical Practice (Hardcover)

The need for writing and implementing effective SOPs in a whole spectrum of fields is on an exponential rise. Unfortuntely, there aren't many SOP books available in the market. This book by Celine Clive is one of a very few fine books on SOPs. It provides quite a few ready to go SOP templates in the clinical field. The templates seem to be consistent with the International standards. The List of SOPs covered include Spnosor/monitor/CRO SOPs, Investigational site SOPs, and Institutional Rebiew Board SOPs. The book also includes some useful forms in the clinical industy. One thing that may concern the reader is that the book is priced very high.
Again, the book is focussed on the clinical industry. If you want a book to learn the basics of writing and implementing effective SOPs that could be applied to any field, begin with the following book:

SOP Workshop: Workshop in a Book on Standard Operating Procedures for Biotechnology, Health Science, and Other Industries
If you are a beginner in the field of SOPs, this book by Dr. Paul Sanghera is your book. It explains the basic SOP concepts from scratch and offers simple examples, exercises, and templates. It's a general book on SOPs that can be used by any reader in any field. It's a good starting point for any professional in any field who wants to start with writing and implementing effective SOPs. Topics covered include: Introduction to SOPs *Effective SOPs *Producing Effective SOPs *Living with Approved SOPs: following, monitoring, and controlling SOPs *Process Based Approach to SOPs *Solutions to Self Test Exercises * Example SOP Templates *Glossary of terms. I specifically like the process based approach to SOPs: very innovative and useful approach. The price is right.

After this book, you can use the book by Celine Clive reviewed above if you are in the clinical field. There is also another good book on SOPs reviewed below:

SOP Guidelines
This book by D.H. Shah covers SOPs in quite a few areas including Production, Quality Control, Quality Assurance, Stores, Engineering, Maintenance and Housekeeping. It also contains SOP templates in these fields. A good collection of SOPs on Tablets & Capsules, Ointments, Quality Control, Liquid Orals, and Sterile Preparations. The book is highly priced, but useful.