SCIENTIFIC REPORT 2004 - Sylvester Comprehensive Cancer Center

S H A R E D R E S O U R C E S
C L I N I C A L R E S E A R C H S E R V I C E S R E S O U R C E
CLINICAL DIRECTOR
Joseph A. Lucci, III., M.D.
Associate Professor of Obstetrics and
Gynecology
ASSISTANT DIRECTOR
James D. Hanlon, Jr., R.N.
Manager
PURPOSE
The Clinical Research Services Resource
provides UM/Sylvester investigators with
broad-based support for their clinical research
activities to:
• Evaluate clinical trial protocol design, scientific
merit, and patient care-related issues through
the UM/Sylvester Protocol Review Committee.
• Provide support services for screening, evaluating,
recruiting, tracking, protecting, and maintaining
patients on clinical protocols.
• Assist investigators with protocol development
by providing consultation in protocol design,
access to other needed resources, and assistance
with reporting requirements and other federal
regulations.
• Assure compliance with guidelines for investigational
drug use and toxicity reporting and
maintain quality data management.
• Develop a data safety and monitoring board to
monitor institutional clinical trials.
• Support national cooperative group activities
and interact with UM/Sylvester affiliates.
• Develop, operate, and maintain a computerized
protocol data management system.
• Budget clinical trial expenditures and negotiate
contracts with clinical trial sponsors.
SERVICES
1) Regulatory Office: This office handles all activities
involving activation of clinical trials, which
include preparing and presenting documents
to both the Protocol Review Committee
and the University of Miami Internal Review
Board, writing informed consents, and distributing
active protocols throughout the clinical
areas on the medical campus.
2) Informatics Office: This office maintains the
database for institutional trials, monitors the
charge-back system, provides lists of active
clinical trials, and assists with quality control
procedures.
3) Budget Office: This office controls the budget
for the Clinical Research Services Resource’s
personal and office expenditures and negotiates
contracts with clinical trial sponsors.
4) Quality Assurance: This office monitors the
quality of data management and conducts case
auditing to ensure compliance with FDA requirements.
It also interacts with the Data
Safety and Monitoring Board.
5) Research Pharmacy: The research pharmacy is
responsible for investigational drug accountability
and inventory, as well as providing drug
information for medical, nursing, and pharmacy
staff.
UM/Sylvester Comprehensive Cancer Center Scientific Report 2004 147