DF/HCC General Contact and Office Information
Clinical Research Support Offices
Clinical Research Agreements Office
Director: Mary Melloni, RN, JD, MBA
The Clinical Research Agreements Office works with industry to negotiate budgets and contracts for PI-initiated trials. For BCH and BIDMC-led trials, the Office works closely with clinical trials negotiators at their respective institutions.
Clinical Trials Business Office (CTBO)
Director: James Huse
The CTBO provides a centralized, comprehensive program of support for sponsored clinical research. Offices at lead sites work with principal investigators and their teams to evaluate budgetary and financial implications for new studies. The CTBO also prepares and negotiates financial terms with industry sponsors; and manages post-award finances including invoices, accounts receivable, funds, distributions, and financial reports.
Office for Human Research Studies (OHRS)
Interim Director: Nicholas Farley
The Office for Human Research Studies (OHRS) oversees the scientific and Institutional Review Board review processes for all cancer relevant research conducted by the five Harvard clinical institutions under the umbrella of Dana-Farber/Harvard Cancer Center. OHRS is responsible for ensuring the administrative and regulatory management, implementation, and operation of the Protocol Review and Monitoring System; the system for the institutional review board review of research; the Health Improvement Portability and Accountability Act as it relates to research; and activation of Research Protocols.
Office of Data Quality (ODQ)
Director: Nicholas Farley
The Office of Data Quality focuses on quality assurance, quality control, and quality improvement processes. The office is also responsible for clinical trials auditing, data safety monitoring, and overall data quality, as required by the Cancer Center Support Grant.
Research Informatics Operations (RIO)
Director: Erica Woulf, MBA
The Clinical Trials Research Informatics Office specifically addresses the growing technological needs of the clinical trials research community. The office provides a collaborative, responsive, integrated and focused approach to all aspects of systems development and support. Areas of particular interest include the continued expansion of OnCore, enhanced integration with Epic and other DF/HCC member institution systems, and clinical trials reporting for the Cancer Center Support Grant (CCSG).
Massachusetts General Hospital Cancer Center Protocol Office (MGH CCPO)
Administrative Director: Robert Herman
The Cancer Center Protocol Office (CCPO) provides centralized data management and administrative management for therapeutic oncology clinical trials conducted within the Massachusetts General Hospital Cancer Center. The CCPO works closely with 14 multidisciplinary disease centers and clinical programs promoting clinical research by providing comprehensive services to physicians conducting clinical trials. These services include: study management, subject tracking, data acquisition, regulatory compliance, monitoring, education, budgeting, Medicare coverage analysis, invoicing, and information services.
Dana-Farber Cancer Institute Clinical Trials Office
Directors: Anne Daoust
The Clinical Trials Office develops policies, procedures, and best practices related to clinical trials; coordinates submission and compliance; assists in the pre-review of protocols before submission for approval; and facilitates clinical research center (CRC) recruitment, onboarding and training. The Office also provides oversight and management of CRC teams, manages the Cancer and Leukemia Group B (CALGB) team, and supports clinical trials programs at satellite locations and affiliates.
Beth Israel Deaconess Medical Center Cancer Clinical Trials Office (BIDMC CCTO)
Interim Director: Joanna Kemp, BSN, RN, OCN
The Cancer Clinical Trials Office (CCTO) at Beth Israel Deaconess Medical Center (BIDMC) supports clinical research and provides infrastructure and services to 12 individual cancer disease programs: AIDS Oncology, Breast Oncology, Cutaneous Oncology, Experimental Therapeutics, Gastrointestinal Oncology, Genitourinary Oncology, Gynecological Oncology, Hematological Malignancies/Bone Marrow Transplant, Radiation Oncology, Renal Oncology, Thoracic Oncology, and Thrombosis/Benign Hematology. To these programs, the CCTO provides centralized coordination of new trial submission and oversight of all regulatory requirements; hiring, training, and mentoring to the CCTO clinical research assistants and research nurses; guidance and support to all disease groups within the CCTO; collaboration with the DF/HCC with seats on the IRB, SRC, and Operations Committee; and a liaison with the greater BIDMC oncology, research, and general communities.