Office of Research Research Administration Clinical Research Support Office (CRSO) Frequently Asked Questions Frequently Asked Questions (FAQ's) Answers to common questions can be found below. I’m having issues with OnCore, who should I contact? I’m having issues with OnCore, who should I contact? 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: 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 How do I get access to OnCore? How do I get access to OnCore? Fill out the OnCore Access Request form found here. How do I get my study into the OnCore system? How do I get my study into the OnCore system? First, become a member of CCTS by filling out the form here. Once you have created a membership, use the "Request Service" link on the right of the page to fill out the form. Where should my clinical trial payment be sent? 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? 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 does the process look like? At what point in my study start-up process should I submit for a coverage analysis? Once I submit, what does the process look like? 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? 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. Other questions about coverage analysis? Other questions about coverage analysis? More details can be found here. How quickly will my study be built into OnCore? 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? What data do I need to enter into OnCore and what are the deadlines? Field Type Data Entry Deadline Accrual Target Prior to active enrollment IRB Information (number, approval date, review type) Within one business day of approval Staff Tab When staff list is submitted to the IRB Grant Number Prior to opening the study to accrual PC Console Status Within one business day Subject PHI/MRN Within one business day Subject Consent Within one business day On/Off Treatment Within one business day Visit Check in date Monthly NCT Number Prior to opening the study For Summary Accrual Only protocols-subject demographic information Gender Quarterly Age Quarterly Race Quarterly Ethnicity Quarterly Zip Quarterly Where can I find training resources? 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 Tools and Resources Protocol Lifecycle Checklist Research Team RPE Checklist and Required Fields Feasibility Checklist Epic FAQs UKHC Based Clinic Facility Fees for Research Other Website Resources CCTS PI 101 training class University budget guidelines for fringe, F&A and other requirements (OSPA)
Skip to main content