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Understanding Study Sponsorship and IRB Processes: A Guide for Research Professionals

celina avatar
celina
7 diapositives · 201 Views · Aug 04, 2014

This comprehensive guide explores the various approaches taken by sponsors and investigators in clinical research. It outlines the processes for reviewing scientific merit, logistical feasibility, and financial considerations, emphasizing the roles of departmental committees, administrative reviewers, and the IRB submission process. Learn about industry-sponsored, federally-sponsored, and foundation-sponsored trials, and how to navigate the necessary documentation and approvals. Understand the classification of research applications (Exempt, Expedited, Full Board Review) and the required certifications for new employees to conduct research successfully.

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Understanding Study Sponsorship and IRB Processes: A Guide for Research Professionals
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  1. Non-CISO Non-CTU Studies: How They Differ February 12, 2014

  2. Various ways • Sponsor approaches physician • Physician approaches Sponsor • Principal Investigator will approach a colleague Participating in a Study

  3. Various ways to review scientific merit, logistical (adequate coordinators, competitive trials, etc.) and financial feasibility • Departmental committee • Administrator Reviewer Departmental Approval

  4. CONTRACTS/BUDGETS IRB SUBMISSION PROCESS OTHER COMMITTEES (eg. Noridian Medicare Analysis, Value Analysis Committee, Conflict of Interest Committee)

  5. 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) Contracts Submission

  6. 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. IRB Submission

  7. 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-online-education-program • https://istar-chla.usc.edu/iStar/Rooms/DisplayPages/LayoutInitial?Container=com.webridge.entity.Entity%5BOID%5B442D5C79B006C04897775F96FD41AF4C%5D%5D New Staff and Faculty: