The University of Kentucky Clinical Research Support Office (CRSO) supports investigators and clinical research coordinators across campus to conduct clinical research. 

We review all clinical research studies to determine if a coverage analysis is needed and if the study is required to be tracked in the CTMS. 

In addition, we can provide fee-based regulatory, recruitment, and clinical trial financial management services to assist investigators and their teams in conducting clinical research.

The CRSO holds office hours via zoom every Friday from 10-11.  Please contact CTMS.Support@uky.edu for zoom information.


Clinical Trials Administrative Support and Billing Integrity

All clinical trials and research studies, regardless of the funding source, must be submitted to the CRSO for OnCore tracking, detailed calendars and coverage analysis and billing review prior to budget finalization.

We have developed a few guidance documents (see helpful links below) to assist your teams in understanding the various processes and what documents and information you need to submit.

The service request form for amendments can be found at: Amendment Submission Form

Details about Coverage Analysis can be found here.

The CRSO Clinical Trials Administrative Support and Billing Integrity team assists study teams with:

  • Understanding if your study needs to be in OnCore and how it needs to be managed

  • Understanding if your study needs to be in Epic

  • Creating your study in OnCore

  • Developing your calendar or detailed schedule of events in OnCore

  • Help you manage your study in OnCore

  • Determining your billing activity and what is needed to support correct patient care billing

  • Developing your coverage analysis and explaining detailed billing designations

  • Helping you to successfully track your participants in OnCore


In the case of a disputed coverage analysis, investigators should contact Dr. William Stoops at william.stoops@uky.edu to initiate the dispute resolution process.

 

Questions about the minimum footprint, coverage analysis or billing integrity process?

Contact the CRSO at CRSOstudyassist@uky.edu

To roll-back a subject or have other data sent to Epic edited, please fill out this form https://forms.office.com/r/xXJJDPXcuc


Financial Management

The CRSO offers clinical trial financial management services for clinical research studies, including:

  • Pricing and budget development
  • Sponsor budget negotiations
  • UK internal forms assistance
  • Sponsor invoicing
  • Payment tracking and reconciliation
  • Reporting and account monitoring
  • Patient stipend and reimbursement payments
  • OnCore budget data entry
  • Epic first tier charge review


Questions about the clinical trial financial management?

Contact the CRSO at CRSOFinance@uky.edu.

 


Regulatory Support

In collaboration with our CCTS partners, the Regulatory Knowledge and Support Core integrates faculty, staff, and community expertise in bioethics, regulatory knowledge, and research integrity to provide investigators and study teams with a single point of access to the spectrum of ethical and regulatory requirements.

The core is comprised of highly trained regulatory specialists who can provide support to investigators that is tailored to their specific needs.


Recruitment Support

In collaboration with our CCTS partners, Participant Recruitment Services (PRS) provides comprehensive recruitment support including consultations for recruitment planning, material development and approval, advertising, outreach, and educational opportunities.