Data and Safety Monitoring/NIH Policy

The AECOM/AECC Data Safety monitoring plan establishes implementation plans for the policies set forth by the National Cancer Institute in the document entitled Policy of the National Cancer Institute for Data and Safety Monitoring of Clinical Trials (http://cancertrials.nci.nih.gov/clinicaltrials/conductinq/dsm-auidelines/paae2V These policies pertain to the monitoring of all clinical trials supported by NCI, and thus encompass all NCI funded clinical trials, intramural, multicenter and cooperative group. The policies and procedures for Data and Safety Monitoring of the clinical research programs at the AECC are established and monitored by the Protocol Review and Monitoring Committee and the Cancer Center Clinical Research Executive Committee. The Data Safety Monitoring Committee is a major component of the Cancer Center and reports directly to the head of the Protocol Review and Monitoring Committee, the CPDMU, the Cancer Center Director and the AECOM/Montefiore IRBs. The document includes the major functions and responsibilities of data and safety monitoring of our active clinical trials program(s) and includes a detailed description of the following: Individual responsible for monitoring The frequency of the review A description of what is being monitored The procedures for different classes of clinical trials The evaluation and investigator feedback/communication process The procedures for managing and averting conflicts of interest Adverse event procedures Suspensions of clinical trials Protocol compliance auditing procedures The Data Safety Monitoring Committee (DSMC) has the responsibility for ensuring data and safety monitoring along with each of the protocol Principal Investigators who are ultimately responsible for the ongoing monitoring and safety of clinical protocols. The DSMC is comprised of investigators from throughout the College and Cancer Center, and have a variety of different expertise. Dr. Richard Gorlick chairs the DSMC. The remainder of the membership is listed in the table below. The DSMC is provided with administrative support, database management, etc., by the CPDMU. The DSMC meeting occurs immediately prior to the PRMC meeting to ensure immediate transmission of information. Representatives of the CCI and PRMC serve in a non-voting capacity on the DSMC to assure communication.