The CCTS Regulatory Knowledge and Support core can help investigators navigate the study start-up process by providing the following services:
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2 hour complimentary consultation
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Assistance with IRB and/or FDA submissions
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Assistance with protocol development
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Creation of a regulatory binder
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Assistance with regulatory documents (i.e. 1572, financial disclosure, site signature, delegation log, CV, medical license, laboratory certification, etc.)
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Serve as a liaison with study sponsor
Quick Links
- 21 CFR Part 11 Verification Statement
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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.
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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
- Principal Investigator 101
Other Resources
- Certificate of Confidentiality (COC)
- Clinical Trial Agreements (CTA)
- ClinicalTrials.gov (CT.gov)
- Confidential Disclosure Agreement (CDA)
- Conflict of Interest
- Institutional Biosafety Committee (IBC)
- Investigational Drug Service (IDS)
- Markey Cancer Center Clinical Research Office
- Office of Research Integrity (ORI)
Contacts
William Stoops, PhD
- Director, Regulatory Knowledge and Support Core
- william.stoops@uky.edu
- (859) 257-5388
Ada Sue Selwitz, MS
- Co-Director, Regulatory Knowledge and Support Core
- ada.selwitz@uky.edu
- (859) 257-9454
