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INTRODUCTION TO CLINICAL RESEARCH - Department of …

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BREAST IMAGINGNON-CANCER STUDIES
Sharon Harris, Clinical Research Coordinator
STUDY APPROVAL PROCESS
SEND PROTOCOLS TO:
Clinical Trials Review Committee (CTRC)
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
RESEARCH APPROVAL COMMITTEES
Clinical Trials Review Committee (CTRC)Reviews scientific integrity and feasibility for all University of Chicago cancer studiesLooks atScientific validityCoolness of studyScientific priority/accrual competition within disease programInterdepartmental collaboration arrangementsUniversity Research Administration (URA)Negotiates contract terms for ALL Clinical Trials Agreements (CTAs)Reviews study budgetAdequacy of fundingItems billed as standard of care (SOC) versus researchInstitutional Review Board (IRB)Protects the rights and welfare of human subjectsRequires CTRC and URA approval prior to reviewData and Safety Monitoring Board (DSMB)Reviews adverse events and ongoing data considerationsScientific and Accrual Monitoring (SAM) CommitteeEvaluates study accrual and progress towards study endpointsCan shut down study for not making adequate progress
Completing Conflict of Interest (COI)http://researchadmin.uchicago.edu/policies_compliance/conflict_interest/Completing CITI Research TrainingCitiprogram.orgAmending the IRB submission to include you as a researcher
REQUIREMENTS TO ENGAGE IN CLINICAL RESEARCH
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 humansNursing 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
OTHER REVIEW COMMITTEES
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.
Faculty and Staff Training Requirements for the Conduct of Clinical Research
Collaboration with other institutionsStudy must be reviewed by all institutions involvedSubmit Protocol to the IRBAll submissions should be routed using the University-wide IRB system, AURA.(http://aura.uchicago.edu/)Copies of cancer protocols and consentshttps://webres.uccrc.org/login/login_adIRB ExemptionsStill require an IRB submissionProspective research databasesIf patients are not consented, their data cannot be used in the analysis
COMMON QUESTIONS ABOUT CLINICAL RESEARCH

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INTRODUCTION TO CLINICAL RESEARCH - Department of …