Chapter-09 Safety and Medical Monitoring in Clinical Trials
BOOK TITLE: Drug Discovery and Clinical Research
Author
1. Vora Sonal
ISBN
9789352705771
DOI
10.5005/jp/books/18166_10
Edition
2/e
Publishing Year
2019
Pages
8
Author Affiliations
1.
Clinical Research, Aventis Pharma Ltd, 54/A, Sir Mathuradas Vasanji Road, Andheri (E), Mumbai, Maharashtra, India,
Aventis Pharma Ltd., Mumbai, Maharashtra, India
Chapter keywords
Medical monitoring,
clinical trial,
data monitoring committee,
DMC,
randomized clinical trial,
RCT,
key responsibility,
DSMB,
data safety monitoring board,
national cancer institute,
NCI,
ethics committee,
electronic data capture,
EDC