Regulatory and Hospital Approval Are we there yet? Rachel Sheppard Regulatory Director, OCRSS

Question Are you handling all functions related to approval? a. All functions b. Clinical and Regulatory c. Clinical and Financial d. Only clinical

Path to enrollment Study team IRBPrivacy BoardsContractingOSPGA Office of Technology Transfer Hospital Offices Sponsor/CRO Department Chair Institutional Biosafety CMSOSPFAPurchasing

Nothing is Automatic Triggers for events Communication is key Details can cause delays Location, location, location Who is engaged in the research?

Jewish and ULH Research Office: KOHRC Timing of review is variable Kentucky One CIRI CHI Who is doing what? Limited Patient Contact Credentialing or CAPS

Norton Healthcare Research office: NHORA Approves for all Norton facilities Review comes with IRB review Credentialing – Limited Patient contact or CAPS

VA Hospital VA Research Office VA IRB Credentialing WOC Application

Baptist Healthcare Application IRB of waiver of oversight to cede to U of L Credentialing - CAPS

What else Contract should be in place Clinics should be aware Sponsor activate your site Must have Investigational Product Site signature logs, Delegation logs, Training documentation

Discussion You have an investigator initiated study. Is it different than industry initiated? a.There is no difference b.Submit to IRB first c.Submit to Hospital first d.It depends

Best Practices Know all the details as early as possible Have a process driver Have triggers to take action and follow up Communicate with all parties