INTRODUCTION TO CLINICAL RESEARCH

Report
Sharon Harris, Clinical Research Coordinator
SEND PROTOCOLS TO:
Sheila Dertz, CCRA
Regulatory Affairs Manager
Cancer Clinical Trials Office
Pamela J. Lofton, RN
Research Nurse Associate
Study Coordinator
[email protected]
[email protected]
ALL CANCER STUDIES
NON-CANCER STUDIES
Clinical Trials Review Committee (CTRC)
Sharon Harris
Clinical Research Coordinator
Joanne Summers
[email protected]
[email protected]
Gloria Frazier
NON-CANCER STUDIES
(Breast Imaging Section Only)
[email protected]
Grants and Contracts Administrators
University Research Administration (URA)
Institutional Review Board (IRB)
Weekly Review by
Data and Safety
Monitoring Board
(DSMB)—for studies
that are more than
minimal risk)
Annual Review by the
Scientific and Accrual
Monitoring Committee
(SAM)
Annual Continuing
Review by the IRB

Clinical Trials Review Committee (CTRC)
◦ Reviews scientific integrity and feasibility for all University of Chicago cancer studies
◦ Looks at
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


Scientific validity
Coolness of study
Scientific priority/accrual competition within disease program
Interdepartmental collaboration arrangements
University Research Administration (URA)
◦ Negotiates contract terms for ALL Clinical Trials Agreements (CTAs)
◦ Reviews study budget



Adequacy of funding
Items billed as standard of care (SOC) versus research
Institutional Review Board (IRB)
◦ Protects the rights and welfare of human subjects
◦ Requires CTRC and URA approval prior to review

Data and Safety Monitoring Board (DSMB)
◦ Reviews adverse events and ongoing data considerations

Scientific and Accrual Monitoring (SAM) Committee
◦ Evaluates study accrual and progress towards study endpoints
◦ Can shut down study for not making adequate progress

Completing Conflict of Interest (COI)
◦ http://researchadmin.uchicago.edu/policies_compliance/c
onflict_interest/

Completing CITI Research Training
◦ Citiprogram.org

Amending the IRB submission to include you as a
researcher

Radioisotopes and Radioactive Drugs Research Advisory
Committee (RADRAC)
◦ Review, approval and surveillance of radioactive drugs as well as the
purchase and use of radioisotopes in humans

Nursing Research Committee (NRC)
◦ facilitate research that builds a scientific base for nursing practice
and promotes the profession as a scientific discipline.

Institutional Bio-safety Committee (IBC)
◦ Reviews biohazards, as defined as potentially infectious agents,
organisms or materials, biological toxins, organisms containing
recombinant DNA and other genetically altered organisms and
agents, in laboratory and clinical settings.

Institutional Animal Care and Use Committee (IACUC)
◦ Review, approval and surveillance of all research and teaching
protocols involving the use of animals


The BSD requires training for all researchers per
policy “Faculty and Staff Training Requirements
for the Conduct of Clinical Research.
◦ Log onto the CITI website (www.citiprogram.org) to
complete this training requirement.
AURA, the new electronic IRB submission and
review system.

Collaboration with other institutions
◦ Study must be reviewed by all institutions involved

Submit Protocol to the IRB
◦ All submissions should be routed using the University-wide
IRB system, AURA.(http://aura.uchicago.edu/)

Copies of cancer protocols and consents
◦ https://webres.uccrc.org/login/login_ad

IRB Exemptions
◦ Still require an IRB submission

Prospective research databases
◦ If patients are not consented, their data cannot be used in the
analysis

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