Georgetown University DSMC
About
The Data and Safety Monitoring Committee (DSMC) is an independent group of experts housed within Georgetown University. The members of the DSMC are tasked with the responsibility of prospective monitoring of all clinical trials assigned to the DSMC, to ensure subject safety, scientific validity and data integrity of clinical research.
The DSMC achieves this goal by periodically reviewing and evaluating the study data and conduct for its safety outcomes, quality, accuracy, completeness and compliance with local and federal regulations concerning clinical research. The DSMC provides recommendations to the study team and may also recommend the study be placed on hold for patient safety and efficacy reasons based on its review. As part of this responsibility, the DSMC maintains confidentiality of DSMC proceedings and study data presented to them.
The extent of data and safety monitoring required for a given study depends on several factors, including the study sponsor, the test agent(s) involved in the study, the risk level encountered by the study participants, and the phase of the clinical trial. The frequency of monitoring may also vary, depending upon the degree of risk associated with participation in the clinical trial, the size and complexity of the clinical trial, the nature of the study, the progress of enrollment, and any special considerations described by the protocol.
If you have questions regarding the DSMC, please contact the DSMC program coordinator at DSMCORQA@georgetown.edu