Frequently Asked Questions (FAQs)

Any investigator who is leading, or planning to lead, a trial that meets the NIH definition of a clinical trial (https://grants.nih.gov/ct-decision/index.htm) should contact the CRSO. The CRSO provides services institution-wide, so we welcome investigators from all colleges.

The CRSO works with investigators on any trial meeting the NIH definition of a clinical trial (https://grants.nih.gov/ct-decision/index.htm). Our office will help investigators with initial coverage analyses and amendments and entry of the trial into our clinical trial management software (e.g., study visit calendar). Depending on the study team needs, we can also help with regulatory, recruitment and financial aspects of the trial on a fee-for-service basis. 

We encourage investigators to contact the CRSO about their trial as soon as possible, even before IRB approval is granted and contracts are signed with sponsors. This enables our team to start building the trial into the clinical trial management software and begin the coverage analysis in a way that expedites the process and ensures study teams can meet their projected timelines. 

Services may be requested through the CCTS/CRSO service request form (https://cctsdata.uky.edu/membership/). If you have other questions, you can contact the CRSO Executive Director, Jessica Heskel, at jessica.heskel@uky.edu.

The Clinical Research Support Office (CRSO) is supported by the UK College of Medicine, UK HealthCare, and the UK Office of the Vice President for Research to offer support for the OnCore clinical trial management system, 21CFR11 validated EDC and regulatory systems, billing integrity, and coverage analysis, as well as finance and regulatory assistance in partnership with the CCTS. The mission of this unit is to facilitate compliance, cost reimbursement, and participant data management through the development and application of best practices. To that end, the CRSO reduces administrative burdens associated with the conduct of clinical trials, enhances clinical trial efficiency, provides tools to study teams that allow for enterprise-wide automation and gathering of important metrics (e.g., clinical trial accruals), and increases compliance with federal and state guidelines. The CRSO also maintains the UK instance of OnCore and integrations with other institutional software. Services include assistance in using the clinical trial management system, OnCore, Advarra Electronic Data Capture system (EDC), the Advarra electronic regulatory binder (eREG) and providing financial management support. CRSO staff build clinical trial protocols into OnCore for study teams to track subject accrual and project timelines, produce the insurance coverage analysis, provide technical support, software training, budget development, negotiation, and post-award management. Regulatory and clinical trials recruitment assistance is also offered. CRSO maintains a staff of 27. 

Two CCTS units, pre- and post- award financial management for industry studies, and regulatory support, have moved under the CRSO umbrella but remain physically housed in the CCTS. 

You can email anytime at CTMS.Support@uky.edu. We will respond to your request as quickly as possible during normal business hours.

Where can I find training resources?

• Training documents can be found on our training Sharepoint 
• Training FAQ on Sharepoint

Fill out the OnCore Access Request form found here.

First, become a member of CCTS by filling out the form. Once you have created a membership, use the "Request Service" link on the right of the page to fill out the form.

The finance team can provide the clinical trial central lock box physical check mailing address or the wire transfer information necessary for all clinical trial payments. Please email the Finance Team at CRSOFinance@uky.edu for details.

Coverage Analysis is a prospective review of all items and services provided in an NIH-defined clinical trial, to determine how each item should be funded. The process involves a detailed review and application of Medicare’s National and Local Coverage Determinations (NCDs and LCDs), as well as specialty guidelines. The process informs your study team of which items can be billed to the patient/their insurance, and which will need to be funded by the study. The CA should be done before your budget is finalized, to ensure all research-related items can be negotiated with the sponsor.

As soon as you have a final protocol and a draft version of your consent form, you can submit your CA request here: https://cctsdata.uky.edu/membership/. As a reminder, this should always occur before your budget is finalized. Once your request is submitted, our CTMS team will build a protocol calendar, and the coverage analysis will then be applied to the calendar. Once the CA is completed and approved by your team, the budget can be finalized and entered into OnCore as well. (Note: there may be specific instances when an OnCore calendar is not required, so the CA may be processed in Excel. For questions about this, please contact a CRSO Coverage Analyst at CRSOstudyassist@uky.edu)

Effective January 1, 2024, the Clinical Research Support Office (CRSO) will charge fees for coverage analysis for new pharmaceutical industry-sponsored clinical trials. The CRSO will charge $3,200 for new industry studies that require full analysis and $1,000 for any significant sponsor-driven amendments that alter the study visits, procedures, or calendar. No overhead will be charged on these fees. The CRSO charges the same, flat rate fee for all industry sponsored clinical trials.  Questions on if your study or amendment will be charged?  Contact a CRSO Coverage Analyst at CRSOstudyassist@uky.edu. 

See our Coverage Analysis page for more information. 

CRSO guidelines set the deadline of five business days for a calendar build and fifteen business days for a coverage analysis.  However, the current median time for both work products is significantly shorter. 

Accrual Target: Prior to active enrollment

NCT Number: Prior to opening the study

IRB Information (number, approval date, review type): Within 1 business day of approval

Staff Tab: When staff list is submitted to the IRB

Grant Number: Prior to opening the study to accrual

Protocol Status (PC Console): Within 1 business day

Subject Registered & Consented: Within 1 business day

On/Off Treatment: Within 1 business day

Visit Check in date: Monthly

For Summary Accrual Only Protocols-limited subject demographics (biological sex, age range, race, ethnicity, zip): Quarterly

For more information visit the Protocol Lifecycle Checklist.

Training documents can be found on our training sharepoint: https://luky.sharepoint.com/sites/CRSO_CTMS_Support/SitePages/OnCore-Training.aspx 

Additionally the training FAQ can be found here: https://luky.sharepoint.com/sites/CRSO_CTMS_Support/SitePages/Frequently-Asked-Questions.aspx

Information can be found on the UK Innovate R&D Partnerships page.

Information can be found on the UK Innovate R&D Partnerships page.