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 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
Please note the 2019 holiday schedule for CCTS Regulatory office:
• Thursday, Nov. 28 (Thanksgiving Day) – Regulatory Unit Closed
• Friday, Nov. 29 (day after Thanksgiving) – Regulatory Unit Closed
• 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)
• 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.