February 12, 2014 Non-CISO Non-CTU Studies: How They Differ.

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Presentation transcript:

February 12, 2014 Non-CISO Non-CTU Studies: How They Differ

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 Foundation (eg. AHA): Submit to Contracts and Grants Office via 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: For your HIPAA certification course go to: education-programhttp://ooc.usc.edu/hipaa-online- education-program chla.usc.edu/iStar/Rooms/DisplayPages/LayoutInitial?Container=com.web ridge.entity.Entity%5BOID%5B442D5C79B006C F96FD41AF4 C%5D%5D