): Clinical Protocol and Data Management The Office of Clinical Research (OCR) is the established office within the Norris Cotton Cancer Center (NCCC) which supports clinical cancer research at Dartmouth. The OCR provides support for investigator-initiated trials (IIT), cooperative group trials (as an NCTN Lead Academic Participating Site [LAPS] and Full Member of ALLIANCE, NRG, and CITN), and corporate-sponsored studies. The mission of the OCR is to assist with the planning, conduct, and compliance of clinical trials, involving cancer treatments and care, and to provide regulatory support for cancer-related population science studies as well. The OCR assures the highest quality of research and adherence to relevant regulations by primary upfront coordination of the study and ongoing review of research compliance. The OCR is a service group within the NCCC to provide investigators support and study data management, as well as protocol development, monitoring for cooperative group studies, screening for potential research participants, and liaison with federal and industry sponsors and regulatory bodies. The OCR provides resource support to the NCCC Scientific Review Committee (i.e., the Clinical Cancer Research Committee [CCRC]), its Quality Improvement Committee, its Clinical Trials Order Set Committee, and its Data Safety Monitoring and Accrual Committee (DSMAC). The OCR has been active in NCI initiatives regarding time-to-activation projects (ADOPT), the Clinical Trial Reporting Program (CTRP), and, most recently, will be overseeing NCCC's receipt of the NCTN LAPS award. The OCR has a track record of piloting new endeavors for the research enterprise within the Dartmouth-Hitchcock Health system, as it supports the largest single research group in the parent organization. With regard to data safety, DSMAC is a chartered multidisciplinary committee charged with overseeing the monitoring of participant safety, the conduct and progress of research protocols, and the validity and integrity of the data of clinical trials at NCCC and its subsites that are not reviewed by another study-specific safety and data monitoring committee. DSMAC has the authority to require protocol amendments needed for subject safety, suspend study enrollment of study activities, or recommend study closure to NCCC's CCRC. NCCC internal monitoring assesses the PI, research team and OCR regulatory, data integrity, and pharmacy compliance for specific protocols. On an annual basis, a minimum of a 10% sample of the NCCC investigator-initiated, working group, and federally funded studies other than NCI cooperative group studies are audited. Industry sponsors are responsible for monitoring and auditing the studies NCCC investigators conduct on their behalf. Depending on the specifics of the protocol, adverse events are reported to the NCI/Sponsor, the FDA, DSMAC and the local IRB. The DSMAC and the IRB have the authority to suspend immediately accrual and protocol activities until concerns related to the severe adverse events are addressed. The NCCC CCRC and the IRB have the authority to close a study immediately due to an unacceptable level of risk to study subjects.
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