Clinical Protocol and Data Management

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CPDM Summary The Clinical Research Support (CRS) office serves as the principal mechanism for Clinical Protocol and Data Management (CPDM) in the Consortium. CRS facilitates the efficient review, approval, and implementation of cancer clinical research throughout the Consortium. CRS services include assistance throughout the protocol life cycle, including protocol development, navigation through review and approval processes, guidance and support in regulatory affairs, training and education, communications, registration of new trials with NCI CTRP, interim staffing, management of cooperative group trials, quality control and assurance, and data and safety management. In 2013, CRS supported 1168 studies, a 29% increase over 2008 and 23% of newly treated patients participated in a therapeutic clinical trial. Since CRS directly manages Consortium training, protocol submission through activation, protocol and consent form control, and provides other critical aspects of clinical trials, its impact to the Consortium's research base is exceptionally strong, and all investigators and study teams conducting clinical research use its services on an everyday basis through the life of a study. CRS staff members are organized into four interactive divisions: Study Implementation Support, Quality and Compliance, Study Support Services, and Data Management and Reporting. Data and safety monitoring encompasses all aspects of data monitoring, verifying data validity and integrity, and ensuring the safety of study participants in clinical trials and clinical trials are monitored based on degree of risk, size and complexity. Together, the Data Safety Monitoring Committee and its Compliance sub-committee ensure that investigator initiated trials are conducted according to all required policies and procedures in order to protect the rights and welfare of human subjects. The Consortium is committed to increasing the participation of minorities and children in clinical research by continuing to build trust and engagement with these populations in our catchment area. New initiatives are underway to minimize barriers to using the health care services of partner institutions, remove eligibility, recruitment or participation barriers, and find ways to encourage participation and retention for populations of all types.