The CCTS Regulatory Knowledge and Support core can help investigators with the ongoing study maintenance process by assisting with the following items:
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Monitoring visits
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Protocol amendments and modification requests
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Adverse event reporting
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DSMB reporting
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Annual continuation review reports
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Annual FDA progress reports
Quick Links
- ClinicalTrials.gov (CT.gov)
- Institutional Biosafety Committee (IBC)
- Markey Cancer Center Clinical Research Office
- Office of Research Integrity (ORI)
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Principal Investigator 101
PI 101 provides a foundational training specifically focused on operational and regulatory elements necessary for the ethical conduct of clinical research.
- VA Research and Development
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
