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Andres Forero, M.D. - Director
Mission
This Shared Facility is a centralized unit within the Comprehensive Cancer Center that provides administrative, regulatory, research nursing and data management support for the conduct of clinical trials.
Facility Description
The CPDM has an operative office and a regulatory office:
Operative Office
Staff: 1 Manager, 13 Study Coordinators, 1 Research Assistant, 3 Data Managers, 1 Research Technician, 8 Clinical Trial Specialists, 1 Program Manager, 1 Administrative Assistant
Structure: Disease/Specialty-Oriented Teams (1 or 2 Study Coordinators, 1 or 2 Data Managers, participant in Disease-Oriented Working Groups).
Services: Patient recruitment and education, coordination of treatment, collection and coordination of protocol-specific data (investigator-initiated, peer-review, cooperative group, industry), monitoring toxicity and conduct of all Cancer Center clinical trials (Clinical Trials Monitoring Committee).
Regulatory Office
Staff: 1 Manager, 3 Regulatory Specialists, 2 Budget/Contract Specialists, 2 Financial Associates, 1 Financial Assistant, 1 Office Support Specialist
Services: Regulatory (IRB, the Center for Clinical and Translational Science Participant and Clinical Interactions Resources - PCIR), NIH and FDA submissions, ongoing regulatory study management including protocol amendments, consent revisions, IRB renewals, progress reports (IRB, FDA, etc.), serious adverse events reporting, administrative activities, study budget development and negotiation, grants and contracts submission, billing compliance.
Research Pharmacy: The staff consists of a pharmacist and staff who support the acquisition, storage, dispensing, and tracking of every investigational agent administered to protocol patients. The research pharmacy is operated independently of the general hospital/clinic pharmacy.
Location: Offices are located on the third floor of the Liberty National Building (five blocks away from the Wallace Tumor Institute). Administrators, nurses, data managers and technicians work closely within other collaborating facilities such as The Kirklin Clinic (patient outpatient facility), University Hospital, Highlands Hospital and the Center for Clinical and Translational Science Participant and Clinical Interactions Resources (PCIR).
Services and Fees
The CPDM develops a complete budget for every protocol. The administrative start fee is a one time charge of $8,000.
Contact Information:
Director: Andres Forero, M.D.
Email:
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Phone: 975-2837
Clinical Trials Manager: Alma del Grosso, R.N. , OCN, CCRP
Email:
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Phone: 934-0337
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