12 Essential Activities Of Clinical Trial Monitoring: A New Approach To Successfully Perform Clinical Trial Monitoring Paperback
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Author 1
T C George
Book Description
The book is a result of 12+ years of author's experience in 100+ clinical trials to provide a focused insight of monitoring activities in more efficient and GCP compliant fashion. The book covers all the essential activities and their applications which includes Investigatory Site Selection and Assessment, Development of Monitoring Plan, Site Initiation, Review of Essential Clinical Trial Documents, Delegation of Duties and Responsibilities at Individual Trial Site, Inventory Planning, CRF Review and Collection, Coordination for Data Management, SAE Review, Regulatory Compliance, Investigational Product Management, Escalation and Management of Violations, Enrollments Tracking, Payment, Correspondence, Site Closure etc.
ISBN-13
9781500666521
Language
English
Publisher
Createspace Independent Publishing Platform
Publication Date
15 Jul 2014
Number of Pages
100
About the Author
With the accomplishment of PhD and Masters in Pharmacy, Dr T C George has been engaged in clinical trial operations for more than 12 years. He has been a part of more than 100 clinical trials on various positions. He started his career as Clinical Trial Coordinator and then appraised to as Clinical Trial Monitor in a short span of time. For a long time he worked as a freelancer for various Sponsor and CROs as a Clinical Trial Monitor. Presently he is working as Project Manager and working on various therapeutic areas of clinical studies. He has won several awards and recognition for his work and dedication.