Clinical Protocol and Data Management

ForeroAndres 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 in the Wallace Tumor Institute.  Administrators, nurses, data managers and technicians work closely within other collaborating facilities such as The Kirklin Clinic of UAB Hospital (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:  mate@uab.edu
Phone:   975-2837

Clinical Trials Manager:  Liz Busby
Email:  busbyrn@uab.edu
Phone:  934-0337

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