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. The DSMB is comprised of a core multidisciplinary team with Ad hoc members appointed as needed to provide specialized expertise.

To determine if your study qualifies for the CCTS DSMB, click here.

The DSMB meets three times a year and protocols are scheduled for review prior to initiation and then on an interim basis during the trial.

 

CCTS Regulatory Core Holiday Schedule

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.  

For assistance, please contact:

  • Ellen Hartman

    • Clinical Research Associate I
    • ellen.hartman@uky.edu
    • 859.218.6610

Other Contacts