Data Safety Monitoring Committee (DSMC)
The Data Safety Monitoring Committee (DSMC) is charged with monitoring the safety and data integrity of all clinical trials conducted through the UH Cancer Center and its partners, and is established in accordance with NIH and NCI guidelines. Specifically the DSMC monitors, evaluates and acts as necessary to address:
- Serious adverse events experienced by local subjects
- Data Safety Monitoring Plans for all local Investigator Initiated (II) Clinical Trials
- Compliance with Good Clinical Practice during the conduct of all local trials
The DSMC reviews and recommends approval or changes to all II Clinical Trials specific Data Safety Monitoring Plans prior to PRMC approval and then continues to monitor safety and data integrity of II studies on a scheduled basis.
The DSMC may recommend suspension or closure of a study to the Medical Director of the Cancer Center to protect human subjects or scientific integrity.