The overall goal of the Clinical Protocol and Data Management (CPDM) resource at Roswell Park is to assist investigators in the development, implementation, conduct, completion, and reporting of clinical trials in a scientifically rigorous and regulatory compliant manner. This goal is carried out by the Clinical Research Services, a centralized resource that oversees a broad portfolio of clinical trials, including institutional trials (investigator-initiated or IIT), national clinical trial network, other NCI-sponsored trials, and industry-sponsored trials. CRS provides infrastructure for all clinical research activities. CPDM staff assist investigators in assembling clinical and scientific content of protocols and developing budgets, as well as facilitating timely and effective protocol review and implementation. CPDM oversight of clinical research studies includes submission of the protocol, amendments, and continuing reviews to the Scientific Review Committee and the Institutional Review Board, and the management and tracking of all regulatory documents. CPDM staff provides administrative support to the Clinical Disease Teams for protocol prioritization and ongoing scientific relevance and the Data Safety Monitoring Committee. CPDM staff assist investigators in documentation of adverse events, outcomes, informed consent, accrual, and data items critical for safeguarding human subjects. CPDM ensures complete and accurate study data by entering the data in a centralized electronic research database. CPDM ensures that all adverse events and their attributions are reported promptly and accurately to the required internal and external regulatory agencies, and provides study sponsors and regulatory agencies with all required study documents. The CPDM has four specific aims: 1. Provide a central infrastructure including a clinical trial management system and technical staff to support Roswell Park investigators in their efforts to promote efficient and effective clinical trial development, activation, and outcome reporting. 2. Ensure clinical research performance in accordance with applicable regulations, policies, and procedures by providing training, and education. 3. Provide appropriate oversight and monitoring of all cancer-related Roswell Park clinical trials, ensuring participant safety, validity and integrity of the data collected, and quality control. 4. Coordinate and cultivate partnerships to promote and facilitate access and implementation of clinical trials within the Roswell Park catchment area, state of New York, and beyond.
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