OnCore Study Start Up

SIFTER Request

Requests for new study builds in OnCore should be submitted through SIFTER (Study Intake Form to Expedite Research) in conjunction with the submission of your study in eIRB as well as CHPS, if applicable. If you are unsure about whether or not a SIFTER record is needed, send us an email at oncore [at] chop.edu (oncore[at]chop[dot]edu) and a member of the OnCore Support Team will be happy to assist you.

OnCore Build

Upon receiving a request for a new OnCore study build from SIFTER, the OnCore Support Team (OST) will begin creating the study’s protocol and calendar. Once complete, the OnCore Specialist will advise the CTFM Budget Analyst that work on the budget can begin. At any point during the process of building the protocol, calendar and budget, it may be necessary to collaborate with the study team to ensure completeness and accuracy of all elements of the OnCore build. This could include preliminary review of the calendar structure and / or pre-negotiation review of the budget.

OnCore Sign-offs

Once IRB Initial Approval has been issued and all elements of the OnCore build are complete, the protocol and calendar / budget must move through separate, final review and signoff processes. The CHOP study coordinator will participate in the review and signoff of both the protocol and calendar / budget, while the Principal Investigator will only need to participate in the review and signoff on the calendar / budget. For additional guidance, visit OnCore's Documents:

• OnCore Job Aid: Protocol - CRC Signoff & Opening to Accrual
• OnCore Job Aid: CRC Budget Review & Signoff
• OnCore Job Aid: PI Budget Review & Sign-Off

Questions regarding the OnCore protocol or calendar should be directed to the OnCore Support Team at oncore [at] chop.edu (oncore[at]chop[dot]edu). Questions regarding the OnCore budget should be directed to the CTFM Budgeting Team at cranalyst [at] chop.edu (cranalyst[at]chop[dot]edu).

OnCore Go-live

In order for a study to be considered fully-live in OnCore, it must have a protocol status of Open to Accrual and a Released calendar / budget. Therefore, after all signoffs have been completed within OnCore for both the protocol and calendar / budget, it is necessary for the CHOP study coordinator to assign a protocol status of Open to Accrual, while the OnCore Support Team will Release the calendar / budget.

EPIC Integrations

Once the study is fully-live in OnCore, the OnCore Support Team will utilize two existing integrations to share study-specific information with Epic. RPE is initially used to share protocol details, thus creating the study’s record in Epic. Once the connection between the OnCore protocol and Epic study has been established, RPE will then be used to automate the process of associating patients to a research study, as well as updating patient enrollment status in Epic, thus eliminating the need for study teams to do this manually. Visit OnCore's Documents: End User Guide: OnCore / EPIC RPE Interface for more details. An additional integration called CRPC will be used by the OnCore Support Team to send the protocol billing grid from OnCore to Epic. Once available in Epic, the billing grid, supports the CTFM charge routing and review process.

Register New Subjects

When a study has a protocol status of Open to Accrual and a calendar / budget status of Released, you can begin associating new subjects to the study in OnCore at any time. Subject registration in OnCore occurs through a demographics integration with Epic, where the subject’s Epic MRN is used as the unique identifier to retrieve demographic information and pull this information into OnCore, making it part of the subject’s OnCore record. For additional guidance, visit OnCore Documents:

• OnCore Job Aid: Registering New Subjects

In the event that the subject is new to CHOP, therefore does not have an Epic MRN, you can submit a request for a new MRN to the CTFM Registration & Charge Review Team through Epic In-Basket Messaging. For additional guidance, visit ISEpicResearchTraining@CHOP > Tipsheets: Research Visit Scheduling Study Coordinator In Basket Workflow. Questions about using Epic In-Basket Messaging can be directed to the CTFM Registration & Charge Review Team at ctfm [at] chop.edu (ctfm[at]chop[dot]edu).

Manage Subject Status

Once a new subject has been registered in OnCore, it is then necessary to provide subject-specific information associated with obtaining consent, determining eligibility, considering the individual accrued (On Study) and associating the subject with a protocol / treatment arm, if applicable. As this data entry is being completed in OnCore, the subject record is being updated to reflect a corresponding subject statuses (Consented, Eligible / Not Eligible, On Study, On Treatment) etc. When a subject achieves a status of Consented, the RPE integration will share the subject study association with Epic, thus assigning the green “Research” flag. As updates to subject status are made in OnCore, RPE will continue to share this information with Epic resulting in adjustment of the patient enrollment status. Visit OnCore Documents: End User Guide: OnCore / EPIC RPE Interface for more details.

Subject Visit Calendar

As subject-specific information is entering in OnCore, an individualized subject visit calendar with activated visits is being generated. Structurally, it will reflect standard segments, visits and procedures associated with the study, but it will also reflect "planned visit dates" which are auto-generated by OnCore based on the data provided. Individualized subject visit calendars allow a study coordinator to quickly review the anticipated visit schedule by month, quarter, or annually and they can be easily exported as a hard copy reference or even provided to a family to assist with future planning. Finally, the planned visit dates will serve as a point of reference when applying a Patient Timeline in Epic. Epic Patient Timelines support research charge routing and are manually applied to a patient’s research study record to capture the anticipated date range when a subject is expected to complete a study visit. For additional details, visit ISEpicResearchTraining@CHOP > Tipsheets: Research Study Timeline Creation. Questions about applying Patient Timelines in Epic can be directed to the CTFM Registration & Charge Review Team at ctfm [at] chop.edu (ctfm[at]xchop[dot]edu).

Pre-visit Confirmation

Per CTFM business process, within 2 business days of a planned research visit, it is necessary to complete the Pre-Visit Confirmation process. This process supports charge routing in Epic and requires that a member of the study team access the subject visit details within OnCore and review for completeness / accuracy and revise if needed.

For additional guidance, visit OnCore Documents:

• OnCore Job Aid: Pre-Visit Confirmation

There may be instances where it is not possible to complete the Pre-Visit Confirmation process in OnCore. Or, you may need to request assistance with scheduling an appointment with CHPS Nursing. Under either of these circumstances, you'll utilize Epic In-Basket Messaging to communicate with the CTFM Registration & Charge Review Team and / or CHPS. For additional guidance, visit ISEpicResearchTraining@CHOP > Tipsheets: Research Visit Scheduling Study Coordinator In Basket Workflow. Questions about Pre-Visit Confirmation or Epic In-Basket Messaging can be directed to the CTFM Registration & Charge Review Team at ctfm [at] chop.edu (ctfm[at]chop[dot]edu).

Post-visit Check In

Per CTFM business process, within 2 business days of a completed research visit, it is necessary to complete the Post-Visit Check-In process in OnCore. This process supports charge review in Epic and invoicing in OnCore. For additional guidance, visit OnCore Documents:

• OnCore Job Aid: Post-Visit Check-In

Questions about Post-Visit Check-In can be directed to the CTFM Registration & Charge Review Team at ctfm [at] chop.edu (ctfm[at]chop[dot]edu).