Regulatory and Hospital ApprovalAre we there yet?

Rachel SheppardRegulatory Director, OCRSS

Question

Are you handling all functions related to approval?a. All functionsb. Clinical and Regulatoryc. Clinical and Financiald. Only clinical

Path to enrollment

Study team

IRB

Privacy Boards

Contracting

OSPGA

Office of Technology

Transfer

Hospital Offices Sponsor/CRO

Department Chair

Institutional Biosafety

CMS

OSPFA

Purchasing

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 differenceb. Submit to IRB firstc. Submit to Hospital firstd. 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