Transcript Cultural Competence Pilot Program in the Ambulatory

Non-CISO Non-CTU Studies:
How They Differ
February 12, 2014
Participating in a Study
Various ways
• Sponsor approaches physician
• Physician approaches Sponsor
• Principal Investigator will approach a colleague
Departmental Approval
Various ways to review scientific merit, logistical (adequate
coordinators, competitive trials, etc.) and financial
feasibility
• Departmental committee
• Administrator Reviewer
CONTRACTS/BUDGETS
IRB
SUBMISSION
PROCESS
OTHER COMMITTEES (eg.
Noridian Medicare Analysis, Value Analysis Committee,
Conflict of Interest Committee)
Contracts Submission
Various Sources
• Industry Sponsored (eg. Novartis): Submit Clinical Trials
Office (CTO) via TRUE 2.0
• Federally Sponsored (eg. NIH): Submit to Contracts and
Grants Office via email
• Foundation (eg. AHA): Submit to Contracts and Grants
Office via email to Henryk Chrostek
• Departmental (eg. Investigator-initiated)
IRB Submission
 Coordinator, research RN, or PI will submit IRB application through
istar. Applications will include protocol, informed consent from on
USC template, measures, recruitment materials, etc.
 Applications fall under 3 classes:
 Exempt: less than minimal risk (no known physical, psychological,
emotional, or financial risk) such as anonymous or publically available
data collection (only IRB can make determination of Exempt status not
PI). Reviewed by Chair or designee.
 Expedited: minimal risk found comparable to daily life such as extra
tube of blood drawn from a patient already undergoing a standard blood
draw. Reviewed by Chair or designee.
 Full Board Review: greater than minimal risk such as research testing
an experimental drug to see if safe or effective.
New Staff and Faculty:
New Employees need 3 certificates (HS, GCP, and HIPAA) in order to
conduct research and gain istar access:
For your Human Subject and GCP certification course go to:
https://www.citiprogram.org/
For your HIPAA certification course go to: http://ooc.usc.edu/hipaa-onlineeducation-program
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