As a Consortium Cancer Center that is comprised of three institutions, we are continuously challenged to ensure that all the cancer trials at our center are conducted with the highest possible standards for safety and scientific integrity. Ensuring the safety and integrity of clinical trials is not only essential to our research, but is also an integral part of meeting expectations for our NCI-designated Comprehensive Cancer Center. One of these expectations is that our Center has a uniform set of policies that govern all cancer-related clinical research.
The Clinical Research Oversight Committee (CROC) is charged with approving and ensuring adherence to Consortium policies and procedures as well as overseeing compliance with applicable regulations and guidelines. The committee is chaired by the Fred Hutch Cancer Center Deputy Director and has representation from each Consortium partner institutions.
The Data and Safety Monitoring Plan (DSMP) outlines policies established by the Consortium for the appropriate oversight and monitoring of the conduct of cancer clinical trials. The Consortium places the highest priority on ensuring the safety of human subjects participating in research trials and is fully committed to ongoing review and refinement of its processes to assure subject safety, data validity and integrity, and regulatory compliance.
Additional policies below ensure the safety of participants, the integrity of data, and the scientific progress of studies including the termination of studies for which significant risks have been uncovered or when it appears that the trial cannot be conducted successfully.
ClinicalTrials.gov Results and Adverse Events Policy
Consortium Study Coordinator Training Policy
Delegation of Authority (DOA) Policy
External Monitoring Reports Policy
Clinical Research Training Requirements Policy
Scientific Review Committee (SRC) Low Accrual Policy
Review of Safety Reports Policy