CRSO Services

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The University of Kentucky's Center for Clinical and Translational Science (CCTS) and the UK Clinical Research Support Office (CRSO) has transitioned to a membership model. This shift will allow us to more effectively manage the needs and services requested by those engaged in research.

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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 Clinical Trial Management System (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 10-11am.

Visit us at the link below:

https://ukth.zoom.us/j/89691523704

Research Systems Management and Education

The CRSO RSME team assists study teams with a variety of OnCore CTMS services including:

Day-to-day OnCore CTMS administration and technical support
Initial and on-going OnCore system training
Data-entry support
Management and monitoring of research interface with Epic
Custom report development
Data extracts and data analysis

If you need new or modified OnCore system access, submit the OnCore Access Request Form.

Questions about OnCore, have data requests, or need technical support?

Contact us at CTMS.Support@uky.edu

Visit us at Open Office Hours every Friday from 10-11am:

https://ukth.zoom.us/j/89691523704

For subject registration errors, dual-enrollment support, or other data-related questions/issues please fill out this form:

https://forms.office.com/r/ddB9spw4FA

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 .

Helpful Links

College of Medicine Grant Submission SRAS

Clinical Trial Agreement Submission and Execution OSPA

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) 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

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 us at CRSOstudyassist@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.

Find additional information and resources, or request these services

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.