TY  - BOOK
AU  - Herson,Jay
TI  - Data and safety monitoring committees in clinical trials
T2  - Chapman & Hall/CRC biostatistics series
SN  - 9781420070378 (hardcover : alk. paper)
PY  - 2009///
CY  - Boca Raton, FL
PB  - Chapman & Hall/CRC
KW  - Drugs
KW  - Testing
KW  - Evaluation
KW  - Statistical methods
KW  - Clinical Trials Data Monitoring Committees
KW  - organization & administration
KW  - Clinical Trials as Topic
KW  - standards
KW  - Data Collection
KW  - Drug Industry
KW  - Research Design
KW  - Safety Management
N1  - Includes bibliographical references (p. 155-166) and index; Introduction -- Organization of a safety monitoring program for a confirmatory trial -- Meetings -- Clinical issues -- Statistical issues -- Bias and pitfalls -- Data monitoring committee decisions -- Emerging issues
ER  -