Clinical Protocol and Data Management

Columbia University Health Sciences, New York NY

Investigators

Linked publications, trials & patents

Abstract

Part I: Clinical Protocol and Data Management (CPDM). The Herbert Irving Comprehensive Cancer Center (HICCC) CPDM comprises 124 FTEs who provide centralized research support services to 73 HICCC Members. These services include comprehensive regulatory support from protocol inception through closure, ensuring timely protocol activation and supporting accrual to trials from all sponsor types by providing centralized units of trained research nurses, coordinators, and data managers to HICCC Members. Research coordination and protocol compliance are enhanced through fostering strong interactions and collaborations between the CPDM and the HICCC’s Research Programs and Disease-Based Teams. As the central data repository of all oncology-related trial activities, the CPDM provides comprehensive reports and performance metrics to key internal stakeholders for operational assessments and clinical trial planning, as well as external reviewers. The CPDM provides effective and efficient training to both its staff and to HICCC Principal Investigators to ensure safe and compliant conduct of clinical trials. The CPDM ensures compliance with NCI’s Clinical Trials Reporting Program (CTRP) and ClinicalTrials.gov reporting requirements. Over the project period, the CPDM has directly supported the HICCC mission through its Aims and has partnered successfully with the Community Outreach and Engagement (COE), and Cancer Research Training and Education Coordination Offices. Part II: Data and Safety Monitoring (DSM). The Data Safety and Monitoring Committee (DSMC) is the primary agent for ensuring data and safety monitoring of HICCC investigator-initiated trials. The DSMC performs risk-based monitoring to ensure the highest level of patient safety and data integrity. Effective quality control functions are instituted as outlined in the HICCC’s NCI-approved DSM plan to ensure protocol compliance. Part III: Inclusion of Women and Racial/Ethnic Minorities in Clinical Research. The HICCC maintains and supports multiple, proactive efforts to promote the recruitment of women and racial/ethnic minorities per NIH mandatory requirements. The CPDM collaborates with the HICCC COE Office to understand the needs of our communities and develop strategies to reduce barriers to enrollment. Part IV: Inclusion of Individuals Across the Lifespan in Clinical Research. The HICCC supports the NIH policy on the inclusion across the lifespan in research. The HICCC is an active member of the NCTN Children’s Oncology Group (COG) and other pediatric clinical trial networks. The HICCC is active in NCI Adolescent and Young Adult initiatives and is a leading participant in the NCI Early Onset Malignancy Initiative. Enrollment of children and older adults is not restricted so long as eligibility criteria are met.