CRS conducts monitoring according to the NCI-approved Institutional Data Safety and 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.