We serve investigators and research participants by providing comprehensive, well-coordinated, efficient infrastructure to ensure participant safety, timely initiation, execution, management and completion of clinical research protocols while adhering to Good Clinical Practice standards.
Effective March 19, the current plan for CCTS Services is as follows:
- We are requesting investigative teams to pause recruitment and study visits both for the in-and outpatient units on any trial that is not therapeutic and of benefit to the participants. We are going to keep both units open with minimal staffing for any therapeutic trial.
- We are suspending all face-to-face monitoring, site visits, and site qualification visits, and we recommend handling this remotely, if at all possible. We are not able as an institution to arrange remote monitoring through our electronic medical record system. However, sponsors/monitors are encouraged to maintain good communication, and delay source data verification until such time when we can safely permit this once again.
- We have pursued use of an alternate research location for one research team at an independent facility to provide for a safer environment for the participants and staff. These trials are treatment based and essential for the participants.
- Several suggestions we recommend in lieu of utilizing our units would include: use of an alternate research location, use of home health nurses, use of telemedicine, postponing visits outside of allowed protocol windows (document this as it relates to the COVID virus outbreak), or use video monitoring for visits.
- We have asked all research teams to pre-screen their participants before any visit to our units and are now asking all staff both CCTS and research staff to check your temperature daily before coming into work and upon entering the units wash your hands. Anyone with a fever, cough or any other respiratory symptom will not be allowed to come into our units. We are also screening prior to seeing any participants in our research units.
- These plans are subject to change depending on institutional guidance. The inpatient unit will remain open for now unless the university should deem it necessary to close them. Everyone should have a contingency plan for their trials should this happen.
If you have any further questions regarding institutional guidelines please go to the ORI website for more information ORI information: https://www.research.uky.edu/office-research-integrity
We realize each trial may present different risks, based upon trial design, trial population and are willing to discuss any questions you may have individually. If you need assistance, please contact Linda Rice, BSN, RN, CCRC, Director of Clinical Operations, at firstname.lastname@example.org or 859-323-6481, or Philip A. Kern, M, CCTS Director.
Including expert clinical staff, experienced coordinators, and community research coordinator/clinical liaison support