Regulatory Documentation in Clinical Research-BIBLE for CRO and CRA

By Kanosia

This book entitled "Regulatory Documentation in Clinical Research-BIBLE for CRO & CRA" is a must read book for aspirants who are engaged in Clinical Research Documentation Preparation as they have to survive in workplace of stricter regulations and statutory compliances. This is a complete textbook on the subject matter and covers the general topic on the writing of various regulatory documents eg.Study Protocol, Investigator's Brochure (IB) & Clinical Research Study Report (CSR) etc. The book is a continuous effort of the author to provide the knowledge and guidance involved in the field of Clinical Research and regulatory documentations. The book summarizes how to write these documents with ease and every step is explained in detail. There is also glossary of terms and Abbreviations given- in which detailed supporting reading material has been provided.

• Format: Paperback
• Language: English
• ISBN: 1515022862
• ISBN13: 9781515022862
• Release Date: July 2015
• Publisher: CreateSpace Independent Publishing Platform
• Length: 160 Pages
• Weight: 1.06 lbs.
• Dimensions: 0.4" x 8.5" x 11.0"