Protocol Data and Safety Monitoring Plans (DSMP)
CRS conducts monitoring according to the NCI-approved Institutional Data and Safety Monitoring Plan.
All clinical research studies that are not monitored by another entity will be monitored by Clinical Research Support.
The frequency and the scope of the monitoring are determined by the risk level of the study. All studies that support an IND held by a Consortium investigator, are Phase I studies, or meet the NIH definition of high risk, are monitored twice per year. All other studies are monitored annually.
Scientific Review Committee (SRC)
The SRC monitors ongoing studies for scientific progress, including accrual rates according to the Consortium Low Accrual Policy.