TY  - BOOK
AU  - Ellenberg,Susan Smith
AU  - Fleming,Thomas R.
AU  - DeMets,David L.
TI  - Data monitoring in clinical trials: a practical perspective 
T2  - Statistics in practice
SN  - 9781119512653 (hardcover)
PY  - 2019///
CY  - Hoboken, NJ
PB  - Wiley
KW  - Clinical Trials Data Monitoring Committees
KW  - organization & administration
KW  - Clinical Trials as Topic
KW  - Data Collection
KW  - methods
KW  - ethics
N1  - Preceded by Data monitoring in committees in clinical trials : a practical perspective / Susan S. Ellenberg, Thomas R. Fleming, David L. DeMets. 2002; Includes bibliographical references and index; Responsibilities of the data monitoring committee and motivating illustrations -- Composition of a data monitoring committee -- Independence of the data monitoring committee : avoiding conflicts of interest -- Confidentiality issues relating to the data monitoring committee -- Data monitoring committee meetings -- Data monitoring committee interactions with other trial components or related groups -- Statistical, philosophical and ethical issues in data monitoring -- Determining when a data monitoring committee is needed -- Regulatory considerations for the operation of data monitoring committees -- Legal considerations for DMCs
ER  -