Our staff assists researchers in carrying out cancer-related clinical trials. This involves reviewing and approving trial protocols, conducting data and safety reviews and continuous research quality improvement.
Clinical Cancer Review Committee (CCRC)
The Clinical Cancer Review Committee (CCRC) is a multidisciplinary committee charged with providing peer review of the scientific merit of clinical research protocols for treatment, prevention, control, or intervention of cancer that investigators at Dartmouth are interested in opening. The CCRC has the authority to approve, require modifications in, or disapprove research activities that fall within its jurisdiction. New cancer research protocols that involve cancer patients and amendments to existing protocols are subject to review by the CCRC.
Email Julie D. Gurnsey at julie.d.gurnsey@hitchcock.org with any questions about this committee and review.
Data Safety Monitoring and Accrual Committee (DSMC)
The Dartmouth Cancer Center (DCC) Data Safety Monitoring Committee (DSMC) is charged with providing peer review of clinical research protocols for which a Dartmouth investigator is both investigator and sponsor of the protocol. The committee reviews toxicity patterns, data integrity, protocol adherence, and progress toward study objectives. The DSMC has the authority to approve continuation of enrollment and treatment of participants, require explanations or clarification of reported research events, or suspend research activities that fall within its jurisdiction. Cancer research protocols that involve cancer patients are subject to review by the DSMC quarterly, biannually, or annually, depending on the level of risk to the participants.
Email Julie D. Gurnsey at julie.d.gurnsey@hitchcock.org with any questions about this committee and review.
Scientific Merit and Accrual Committee (SMAC)
The Scientific Merit and Accrual Committee (SMAC) is an NCI-designated, required subcommittee of the Clinical Cancer Review Committee (CCRC). The cadre members of SMAC include the CCRC chair and vice chair and a senior CCRC member who is a clinical trial PI. The SMAC administrator is the CCRC administrator/Protocol Review Specialist, who generates the study reports to be discussed by SMAC, takes minutes, and informs the PI/study team of SMAC actions.
The SMAC is charged with providing review of the scientific merit and ensuring that the accrual to a cancer clinical study is in line with the total projected accrual for the study required to achieve the scientific goals of the study. Accrual to a study is calculated using the information detailed in OnCore and is reviewed by the SMAC 6 months after study activation and then every 9 months while a study is open to accrual at Dartmouth or more frequently if necessary. A study is considered to have low (sub-optimal) accrual if it has enrolled less than 50% of expected local enrollment for the time point being reviewed. The SMAC has the authority to approve, require modifications in, or disapprove research activities that fall within its jurisdiction. The SMAC then reports its actions to CCRC with recommendations to pause or close studies to enrollment and these recommended actions are discussed by the CCRC, who can affirm or not affirm the SMAC recommendations. The CCRC will then communicate closure of a study or continuation of enrollment to the clinical study PI/research study team as well as OCR leadership.
Email Julie D. Gurnsey at julie.d.gurnsey@hitchcock.org with any questions about this committee and review.
Clinical Trials Investigational Order Set Committee (CTIOSC)
The Clinical Trials Investigational Order Set Committee (CTIOSC) is charged with the development, review, revision, approval, and deployment, of investigational order sets for Hematology-Oncology clinical trials. Hematology-Oncology clinical research studies using parenterally administered drugs require the use of Investigational Pharmacy Order Sets approved by the CTIOSC. The CTIOSC reports to the Pharmacy and Therapeutics (P&T) Committee through Hematology-Oncology Drug and Practice Specialty Panel P&T. The P&T Committee has delegated the authority to approve Investigational Pharmacy Order Sets to the CTIOSC. The CTIOSC meets weekly.
Prior to study activation, order sets are developed by a Research Pharmacy pharmacist using the order set template. Order sets are reviewed the by research nurse assigned to the study, edited, reviewed by the CTIOSC. CTIOSC approved order sets are then sent to the study PI for final sign-off prior to posting in OnCore. Revisions to investigational order sets will occur expeditiously in response to protocol amendments or identified safety issues.
Email Douglas D. Parr at douglas.d.parr@hitchcock.org with any questions about this committee.
Cancer Clinical Research Quality Improvement Committee (QIC)
The QIC focuses on continuous clinical research process improvement at the Dartmouth Cancer Center. They analyze trends in the quality of research by quarterly reviews of protocol deviation reports, local serious adverse event reports, ongoing corrective and preventative actions plans, reports from research ancillary support services, and reports from principal investigators, NPs, clinical research coordinators, research nurses, regulatory staff, and administrators.
Email Julie D. Gurnsey at julie.d.gurnsey@hitchcock.org with any questions.