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
Please note the 2019 holiday schedule for CCTS Regulatory office:
November 2019
• Thursday, Nov. 28 (Thanksgiving Day) – Regulatory Unit Closed
• Friday, Nov. 29 (day after Thanksgiving) – Regulatory Unit Closed
December 2019
• Friday, Dec. 13th – the Regulatory Unit Closed after 1pm for a CCTS function
• Monday, Dec. 23 - Wednesday, Jan. 1 Regulatory Unit Closed (Reopening Thursday, Jan. 2)
Please note:
• We realize this extended closure may be inconvenient for you and may affect your study schedules. If you have questions, need further clarification, or if any of the above presents a problem to you or your research team, please contact Laura Ashe at (859) 323-2782 or Laura.Ashe@uky.edu no later than November 29, 2019.
• With the cold weather coming soon, we want you to be aware, that if the University announces planned delays or closures (Plan B), the regulatory unit will operate on the delayed schedule or will be closed.
Quick Links
- ClinicalTrials.gov (CT.gov)
- Office of Research Integrity (ORI)
- Institutional Biosafety Committee (IBC)
- Markey Cancer Center Clinical Research Office
- VA Research and Development
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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.
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
