Examples of Data and Safety Monitoring Board in a sentence
Working committees include but are not limited to the Data and Safety Monitoring Board (DSMB), Steering Committee and Executive Committee.
The committees: Data and Safety Monitoring Committee (DSMC) for Phase I and II clinical trials, and the Data and Safety Monitoring Board (DSMB) for Phase III clinical trials, report to the Center’s Research Council and Institutional Review Board.
Please refer to: NIAID Principles for Use of a Data and Safety Monitoring Board (DSMB) For Oversight of Clinical Trials Policy.
A Data and Safety Monitoring Board (DSMB) is an independent group of experts that advises funding IC(s) and the study investigators.
Data and Safety Monitoring Board – an independent committee charged with reviewing safety and trial progress and providing advice with respect to study continuation, modification, and termination.
The committees: Data and Safety Monitoring Committee (DSMC) for Phase I and II clinical trials, and the Data and Safety Monitoring Board (DSMB) for Phase III clinical trials, report to the Center’s Research Council and Institutional Review Board.During the protocol development and review process, each protocol will be assessed for its level of risk and degree of monitoring required.
These summaries will be available for inspection when requested by any of the regulatory bodies charged with the safety of human subjects and the integrity of data including, but not limited to, the oversight (Office of Human Research Ethics (OHRE) Biomedical IRB, the Oncology Protocol Review Committee (PRC) or the North Carolina TraCS Institute Data and Safety Monitoring Board (DSMB).
Data and Safety Monitoring Board oversight is not planned for this study.
An independent Data and Safety Monitoring Board (DSMB) chartered by NIAID/DAIDS provides oversight of ongoing Phase IIB and Phase III MTN studies.
NIH policy specifically requires the establishment of a Data and Safety Monitoring Board (DSMB) for multi-site clinical trials involving interventions that entail potential risk to the participants, and generally for Phase III clinical trials.