DSMC definition
Examples of DSMC in a sentence
Assuming a positive recommendation, the DSMC will also perform a sample size re-estimation at this time.
If the DSMC cannot meet face-to-face, a conference call is acceptable.
The UM Prevention Research Base DSMC meets monthly by means of regularly scheduled meetings.
The DSMC will review enrollment and safety data at regular intervals.
For any deviation, the Investigator will notify the COH DSMC and IRB within 5 calendar days of its occurrence via iRIS in accordance with the Clinical Research Protocol Deviation policy.
These results will be reviewed by the DSMC, the DMCC, and others as needed and will be made available to the NCI.
An independent DSMC will be established to monitor the progress of the study, ensure that the safety of subjects enrolled in the study is not compromised, and determine if the study should be stopped for futility/efficacy or the study population should be enhanced with a higher percentage of patients with lower baseline LVEF to meet the initial event rate assumptions included in calculations of study sample size/power.
The DSMC is empowered with the authority to recommend a trial be suspended or terminated based upon concerns in any of the above areas of review.
Despite the safety and minimal risk of the proposed intervention, we have established a Data Safety and Monitoring Committee (DSMC) to assure safety of participants and to monitor the progress of the research study.
There will be 2 independent committees used in this study: a Steering Committee (SC) and a Data and Safety Monitoring Committee (DSMC).