About the DSMC

Overview of the Data and Safety Monitoring Committee (DSMC)
In response to the NCI requirement for Cancer Centers to develop Data and Safety Monitoring programs, the ACC established a comprehensive Quality Control (QC), Quality Assurance (QA), Regulatory Affairs (RA) and Pharmacovigilance (PV) system for all cancer based human subject research that has been in place since September 2001. These responsibilities are met through the Data and Safety Monitoring Committee (DSMC) which oversees study monitoring and auditing, safety reviews, and the development of study monitoring plans, as well adherence to the Cancer Center's NCI approved institutional Data and Safety Monitoring Plan. For pediatric cancer studies, the DSMC has a sub-committee, the Clinical Research Quality Assurance committee (CRQA), based in the Children's Hospital of Philadelphia (CHOP). This sub-committee is directed by the DSMC and mirrors the activities, policies and procedures of the adult committee.

The DSMC was created as the entity within the ACC responsible for ensuring that all cancer-related human subject studies are conducted in accordance with all federal (e.g. GCP, GMP, GLP, GEP, GTP, HIPAA, Part 11, FISMA etc.) and institutional policies with the goal of improving subject safety and data quality and integrity.

The DSMC functions independent of the CTSRMC, and reports directly to the ACC Director.

Responsibilities of the DSMC
The DSMC accomplishes its wide-spread QC and QA and RA initiatives through prospective study monitoring (QC), routine study auditing (QA), reviewing subject safety issues, evaluation of protocol deviations, review of on-site Adverse Events (AE) and both on and off-site Serious Adverse Events (SAE), assessment and development of SMPs and examination of evaluations conducted by industry site monitors, Medical Monitors and Data and Safety Monitoring Boards (DSMB). Documentation of compliance activities, pending QC/QA assessments, mandated corrective actions and a comprehensive table of event reports generated from the PV database are reviewed at each meeting. Additionally, all deviations and external evaluation documentation since the last meeting are reviewed. The committee may request new or ongoing corrective actions and detail required aspects of the Corrective Action Plan (CAP) to improve study safety and quality. In the event the issue could potentially affect subject safety, the IRB is notified of Committee actions. The committee may also request follow-up information on AEs/SAEs and make recommendations in regards to the status of the study or consent form modifications if there are concerns about safety or quality. The oversight activities of the DSMC are in addition to the study-specific monitoring that the DSMC requires from the study Principal Investigator (PI).

The DSMC, in consultation with the ACC Director, has the authority to suspend or terminate a protocol, investigator or program for safety concerns and/or major audit deficiencies. In the event a suspension or termination is handed down, the IRB is immediately notified of the action and will concur, thus all activities will cease until issues are resolved to the DSMC's satisfaction.

Structure
Dr. Steve Schuster Chairs the Committee. Vicki Sallée, DSMC Director, is responsible for the overall organizational management of the auditing functions of the committee as well as education and training.

Members