Clinical Protocol and Data Management

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PROJECT SUMMARY: CLINICAL PROTOCOL AND DATA MANAGEMENT Part I: Clinical Protocol and Data Management (CPDM). The Sylvester Comprehensive Cancer Center (Sylvester) Clinical Research Services (CRS) provides Clinical Protocol and Data Management (CPDM) support for the conduct of cancer-related research studies at Sylvester, including the Downtown Miami Campus and four satellite locations. CRS comprises three units: 1) The Clinical Trials Coordination Unit (CTCU); 2) Research Committee Support Unit (RCSU); and 3) Quality Assurance Unit (QAU). The purpose of CRS is to provide a centralized, high quality infrastructure to support investigators with developing, implementing, and reporting on all Sylvester cancer research studies, with the safety of participating subjects as the highest priority. CRS assists with the activation and completion of clinical studies, accurately reports clinical study data, and ensures consistency and quality for all studies. The CTCU is comprised of Operations (Research Nurse support, data management, and study coordination) and Regulatory Affairs (regulatory support for timely initiation, compliance, and all protocol review and approval processes). The RCSU facilitates the administration of research committees. including the Protocol Review and Monitoring Committee and Data and Safety Monitoring Committee. The QAU ensures patient safety by providing quality assurance and training for CRS staff and monitoring compliance with Sylvester’s Data and Safety Monitoring Plan (DSMP) and all applicable policy and regulations. CRS supports National Clinical Trials Network, NCI-funded, peer-reviewed, investigator-initiated, and industry-sponsored studies. CRS uses the clinical trial management system Velos eResearch for patient and protocol registration and tracking requirements. In CY 2017, Sylvester CRS supported 1,518 interventional, 509 interventional treatment, and 3,050 non-interventional accruals. Part II: Data and Safety Monitoring (DSM). Sylvester’s DSMC performs risk-based monitoring to ensure the highest levels of patient safety for all Sylvester investigator-initiated studies. CRS provides effective quality control and education to Sylvester investigators and research staff to ensure compliance with the Sylvester DSMP. Part III: Inclusion of Women and Minorities. Sylvester has initiated and sustained many proactive efforts to promote recruitment of women and minorities into research. In CY 2017, enrollment to interventional studies comprised 45% women, 52% Hispanic, and 22% racial minorities, including Blacks and other individuals who self-identify as non-white. Part IV: Inclusion of Children. Sylvester supports the NIH policy and guidelines on the inclusion of children in research. As a member of the Children’s Oncology Group (COG) and the COG Pediatric Bone Marrow Transplant Consortium, Sylvester maintains a comprehensive clinical study portfolio for all pediatric cancers.