Frequently Asked Questions (FAQs)
Which investigators should contact the CRSO about their projects?
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.
What types of trials does the CRSO assist with?
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.
When should investigators contact the CRSO?
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.
Are there fees for CRSO services?
Effective Aug. 1, 2020, the Clinical Research Support Office will begin charging fees for coverage analysis for new qualifying pharmaceutical industry-sponsored clinical trials. The office will not charge fees on studies that have already started or are in the process of starting before Aug. 1
The CRSO will charge $3,200 for new qualifying industry sponsored studies and $1,000 for any significant sponsor-driven amendments that alter the study visits, procedures or calendar. The office will send an invoice directly to sponsors, but study teams must include it in their study budgets.
What is the Clinical Research Support Office facilities description?
The Clinical Research Support Office (CRSO) was created in 2018 as a partnership between the University of Kentucky (UK) College of Medicine, UK Health Care, the Office of the UK Vice President for Research and the UK Center for Clinical and translational science. The goal for establishing the CRSO was to reduce administrative burdens of conducting clinical trials, enhance efficiency, provide tools to study teams that allow for enterprise wide automation and gathering of important metrics (e.g., clinical trial accruals) and increase compliance with federal and state guidelines. As such, the CRSO is dedicated to providing services to assist in utilization of the clinical trial management system, OnCore, and providing financial management support. Our staff of thirteen, under the direction of Dr. William W. Stoops, build clinical trial protocols into OnCore for study teams to track subject accrual and project timelines, produce the insurance coverage analysis, provide IT support, software training, budget development, negotiation and post award management. The CRSO also oversees the maintenance of the University instance of OnCore and the integrations with our other institutional software.
I'm having issues with OnCore, who should I contact?
Where should my clinical trial payment be sent?
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 them for details.
What is a Coverage Analysis, and why do I need it?
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.
At what point in my study start-up process should I submit for a Coverage Analysis? Once I submit, what happens?
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)
Are there fees associated with the Coverage Analysis?
Yes, for any study submitted to the CRSO on, or after, August 1, 2020 there are fees for all industry sponsored, qualifying, trials and any significant amendments. The start up coverage analysis is $3,200 and any significant amendment will be $1,000. Questions on if your study or amendment will be charged? Contact the CRSO at CRSOstudyassist@uky.edu.
How quickly will my study be built into OnCore?
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.
What data do I need to enter into OnCore and what are the deadlines?
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.
Where can I find training resources?
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