Research

Q: Which statuses stop review and billing for research-related services? A: Billing offices will cease review and/or billing with the subject statuses of "Not Eligible," "Withdrawn," "Off Study," or "Expired."

Q: What is the OnCore definition/functionality of "On Study?" A: "On Study" is defined as the date the study subject has been registered to the study after having completed the eligibility step. A subject is considered accrued on a study when they are assigned “On Study” status.  The "On Study" date is the required date in OnCore for accrual credit. It is not related to billing. In the CTMS workflow, subjects will be marked as "Billing Active" in Epic as soon as they have consented to the study and have a consented date recorded in OnCore.

Q: How do you differentiate between "On Follow Up" date and "Off Treatment" date? A: The "Off Treatment" date is the date the study subject stops the treatment phase of the protocol. They are not expected to receive any further interventions or enroll in other treatment arms. After an "Off Treatment" date is added, the subject may move to "Follow Up" or "Off Study" status.

IMPORTANT: For studies tracking subject visits in a study calendar, after the "Off Treatment" date and/or "On Follow-Up" date is added, you may not be able to complete visits from the "On Treatment" phase/segment of the protocol.

Q: What about observational studies? Do the statuses of "On Follow Up", "On Treatment" and "Off Treatment" apply to these studies? A: "On Treatment", "On Follow Up", and "Off Treatment" statuses don't necessarily apply to all studies. For example, subjects on observational studies may directly progress from "On Study" to "Off Study" without being marked as "On Treatment", "Off Treatment", or "Follow Up".  While a Treatment consent is not required for any subjects on these studies, a consent

Q: Do we need to enter subjects enrolled at external sites? A: External site enrollments for oncology protocols must be entered when the University of Vermont Cancer Center (UVMCC) is acting as the coordinating center for all research conducted under the authority of the Signatory Institution (UVMCC) and covered by the CIRB, and when the PI is from the University of Vermont or Medical Center’s Health Network.

Q: What document type name should I select for my document? A: Document type names should match the type of document you are uploading. It's important to use unique and consistent document type names throughout the life of the study. For example, if there is more than one consent form, assign "Treatment Consent" to the treatment consent form and “Tissue Consent” to the tissue consent. Whenever an updated version is uploaded or re-entered during annual reviews, keep the same document type name. This is crucial for version control, document search, and re-consent workflows. Only if the Consent is a general consent form and does not fit into any of the consent categories should the type “Consent” be used.

IMPORTANT: “Treatment consent” will be required for subject registration consent when the University of Vermont Cancer Center is acting as the coordinating center in trials involving treatment.

Q: Who will access documents from OnCore? A: Study teams, clinic staff, and administrative offices with designated access rights will have access to protocol documents in OnCore based on their roles and permissions.

Staff requiring access to protocol documents in OnCore may request access through the CTMS Access request form via RedCap:
(https://redcap.med.uvm.edu/surveys/?s=3RLXFYYCHNMTTYAF)

Q: Which protocols are required to upload documents to OnCore? A: The following protocols are required to have documents uploaded to OnCore:

1. All institution/Epic-active protocols with clinical activities, billing, orders, or protocols that need to release subjects to monitors in Epic.
2. Oncology-related protocols (Oncology library in CTMS) meeting the following criteria:
   • Has consent form documents
   • Has a Data Table 4 Type of Interventional, Observational, or Ancillary/Correlative
3. All protocols requiring a CHRMS or CHRBS full committee review.
4. All studies that meet the NIH definition of a clinical trial, typically involving interventional research.
5. All studies that are FDA-regulated or have any level of FDA oversight. 

NOTE: Protocols that do not meet the above criteria may have documents uploaded at the discretion of the study team. 

Q: Who do I contact if a document in OnCore is missing or the version is not correct? A: If a document is missing from OnCore or the version is incorrect, you can contact the study team's Regulatory Coordinator listed in the "Menu > Protocols > PC Console > Main > Staff" tab. Hover your cursor over the staff member's name, and their contact information will be displayed. If you cannot locate or reach the Regulatory Coordinator, please contact the primary clinical research coordinator for assistance.

Q: What documents are available in OnCore's Document Search? A: The following study documents must be maintained by the study team in OnCore:

Q: Should I delete previously uploaded documents after a new version is uploaded? A: No, do not delete previously uploaded versions. OnCore will replace the most recent uploaded version in Document Search. However, certain central offices may still need access to previous versions, which will be accessible under the tab they were originally uploaded.

Q: How can we search for documents in OnCore? A: You can search for documents in OnCore using the "Document Search" functionality (Menu > Protocols > Document Search). You can search for documents using various protocol identifiers, such as Protocol Number, IRB Number, Pharmacy Number, Sponsor Number, IND Number, IDE Number, Investigator name, or keywords found in the title, short title, or objectives.

Q: Is it possible to print the consent footer and date of printing from OnCore? A: Yes, the functionality to print a consent footer with the date of printing will be available in OnCore when document access goes live. Please refer to the "Document Search & Print Job Aid" for more information.

Q: Will external performance sites have access to our CTMS for multi-site trials when we are the coordinating site? A: Yes, and their access rights and permissions can be configured to only allow them to view, add, and/or edit studies and subjects they should be working on.

Q: Will we be required to enter data collected for the study into OnCore? A: No, data collected from subject activities (e.g., study endpoint data, lab results, imaging results, questionnaires) and used for data analysis are not entered into OnCore. OnCore is primarily used for managing the overall study processes and tracking study-related information, not for capturing granular research subject data. This data can be entered in an EDC system such as Redcap.

Q: How do I submit a new protocol or a study amendment? A: The process for submitting new protocols or study amendments remains unchanged and should be done through our existing systems and processes, using CLICK.  It is worth noting that much of the study information and IRB decisions documented in CLICK will automatically flow to OnCore via interface and be effective after the CLICK to OnCore interface is live.

Have a question or need extra support or training? Reach out to: OnCoreSUpport@med.uvm.edu