Regulatory Start-up Support Services | UK Center for Clinical and Translation Science

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The CCTS Regulatory Knowledge and Support core can help investigators navigate the study start-up process by providing the following services:

2 hour complimentary consultation
Assistance with IRB and/or FDA submissions
Assistance with protocol development
Creation of a regulatory binder
Assistance with regulatory documents (i.e. 1572, financial disclosure, site signature, delegation log, CV, medical license, laboratory certification, etc.)
Serve as a liaison with study sponsor

21 CFR Part 11 Verification Statement
Data Safety Monitoring Board
The CCTS Regulatory Knowledge and Support Unit's Data Safety Monitoring Board (DSMB) conducts interim monitoring and oversight of CCTS supported trials.
FDA Advisory Committee
Assists investigators in assessing the need for an IND and provides guidance on study design
New Study Checklist – Industry Sponsored Study
New Study Checklist – Investigator Initiated Study
Non-Indemnified Clinical Trials
The University of Kentucky Healthcare Risk Management Committee (UKHC RMC) administers a self- insurance program to protect its physicians from medical malpractice claims, which could result from their participation in the conduct of clinical studies. UKHC RMC review is required for all clinical studies that are investigator-initiated and studies where the sponsor does not provide indemnification or limits time or dollar amount of indemnification for medical malpractice liability.
Principal Investigator 101