DATA AND SAFETY MONITORING/ NIH POLICY

Case Western Reserve University, Cleveland OH

Investigators

Linked publications & trials

Abstract

PROJECT SUMMARY (See Instructions); The responsibility for data and safety monitoring in the Case CCC rests with the Data Safety and Toxicity Committee (DSTC). The DSTC resides within the Case CCC Clinical Research Office (CRO), which oversees and coordinates the activities of the Clinical Trials Core Facility (CTCF), Protocol Review and Monitoring Committee (PRMC), Data and Safety Monitoring, and Protocol Specific Research Support. The charge of the DSTC is to oversee all aspects of data and safety monitoring for institutionally sponsored trials, investigator-initiated trials and, in particular, those trials that do not have external monitoring, such as those supported by NCI through ROI, R21, P01, and U01 mechanisms; and to provide oversight for patient safety for all other trials (i.e., industry-sponsored). The DSTC membership includes diverse expertise from consortium institutions including: medical oncology, radiation oncology, surgical oncology, biostatistics, pharmacy, nursing and quality assurance. In accordance with the Case CCC Data and Safety Monitoring Plan (approved by NCI in December 2011), the DSTC is responsible for reviewing the following: 1) al! internal serious adverse events (SAEs); 2) externally submitted IND action letters; 3) IRB continuing reviews including review of toxicity; 4) internal and external audit reports; 5) confirmation of objective responses reported in investigator-initiated studies; and 6) early stopping rule milestones as appropriate for the degree of risk in the particular clinical trial. The DSTC is an independent committee that has the authority to immediately suspend a trial for safety considerations. The DSTC communicates its actions to the Pl, IRB, PRMC, and to the Case CCC Associate Director for Clinical Research.