The CCTS Regulatory Knowledge and Support core can help investigators navigate the study close-out process by providing the following services:
- Assistance with preparing the IRB final review
- Assistance with preparing the FDA final report
- Assistance with sponsor close-out
- Archiving of all study files
Quick Links
- Destruction of Study Records
- Investigational Drug Service (IDS)
-
Principal Investigator 101
PI 101 provides a foundational training specifically focused on operational and regulatory elements necessary for the ethical conduct of clinical research.
Other Resources
- ClinicalTrials.gov (CT.gov)
- Data Retention and Ownership Policy
- Institutional Biosafety Committee (IBC)
- Long-term storage at Kentucky Underground Storage (KUSI)
- Markey Cancer Center Clinical Research Office
- Material Transfer Agreement (MTA)
- Office of Research Integrity (ORI)
- 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
