Clinical Protocol and Data Management

The Herbert Irving Comprehensive Cancer Center (HICCC) CPDM provides centralized research support services for cancer clinical trials. 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.  As the central data repository of all oncology-related trial activities, the CPDM provides comprehensive reports and performance metrics, effective and efficient training to ensure safe and compliant conduct of clinical trials, and ensures compliance with NCI’s Clinical Trials Reporting Program (CTRP) and ClinicalTrials.gov reporting requirements.

We work closely with patients, physicians, hospital staff, the Protocol Review and Monitoring Committee (PRMC), the Data and Safety Monitoring Committee (DSMC), and the Institutional Review Board (IRB), to ensure clinical trials are run safely and effectively.

1. 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. 
2. Inclusion of Women and Minorities in Clinical Research. The HICCC maintains and supports multiple, proactive efforts to promote the recruitment of women and underrepresented minorities (URM). The CPDM collaborates with the HICCC Community Outreach and Engagement Office to understand the needs of our communities and develop strategies to reduce barriers to enrollment for URM individuals.
3. 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.  

CPDM Leadership

• Medical Director: Andrew Lassman, MS, MD, FAAN
• Director, Clinical Research Operations: Frances Brogan MSN, RN, OCN, CCRP
• Assistant Director, Clinical Research Operations: Ryan Shelton, BS
• Assistant Director, Clinical Research Nursing and Quality: Edward Bentlyewski, MSN, APN, NP-C, AOCNP, CCRP
• Finance Managers: Jashira Rodriguez, BS, & Marina Greenberg, MS
• Research Manager, Quality and Safety: Mariangela Agovino, MPH
• Senior Regulatory Manager: Suzanne Mistretta, MS, CCRP
• Regulatory Science Manager: Adam Scott, BS, CCRP

Clinical Research Managers

• BMT/Hematologic Malignancies/Myeloma: Deeksha Kaura, BDS, MS, ACRP-CP
• Hematologic Malignancies/Lymphoma: Beatriz Raposo-Corradini, MSc
• Breast/Cooperative Groups:  Erik Harden, MA
• GU/Urology: Jillian Gray, BS
• Phase I: Alyssa Schumpp, MS
• Melanoma/Sarcoma/Thoracic: Moury Minhaz, MS
• Multi-Center Trials: Naomi Sender, BS,  & Sarah StaAna, MS
• Neurologic Malignancies/GI: Kriti Bagri Manjrekar, MDS, PGD- HP