|
KMID : 1011320090020010026
|
|
Journal of Pharmacoepidemiology and Risk Management
2009 Volume.2 No. 1 p.26 ~ p.29
|
|
|
Monitoring the safety of Clinical Trials: Role of the date Safety Monitoring Board
|
|
Han Seo-Kyung
|
|
|
Abstract
|
|
|
When conducting a long-term clinical trial, it is desirable to ensure that there is no increased risk of harm for the participants. It is also important to ensure that a trial continues without stopping too early to answer its scientific
questions. An independent Data Safety Monitoring Board (DSMB), as a group of experts external to a study, serves such tasks by reviewing accumulated data from an ongoing clinical trial. The paper intended to provide an overview to highlight the key issues involved when investigators include DSMB as part of their clinical trial management. We have outlined the general principles, constitution of the membership, and the operating relationship with the Institutional Review Board.
|
|
|
KEYWORD
|
|
|
Data safety, Data safety monitoring board, IRB
|
|
|
FullTexts / Linksout information
|
|
|
|
|
|
Listed journal information
|
|
|
|