New Calendar Intake Form

Use this form to request an initial OnCore Calendar build.

IRB#*

OnCore Protocol No.

PI*

PI Department*

Select or enter value

Requestor Name*

Requestor Email*

IRB Approval Date

For SIRB Studies: Enter the Initial Approval of the IRB of Record; not the WU Request to Rely approval.

Any arms that should be excluded?

Yes

Which arms should NOT be included in OnCore?

Can a subject crossover into another arm or undergo retreatment on the same arm?

Yes

Which arm(s) can crossover to which arm(s), and can the subject have any EoT or F/U visits on the original arm before crossing over?

Which arm(s) can be retreated again on the same arm, and can the subject can have any EoT or F/U visits before being retreated?

This study will bill services as:*

100% Research

100% Standard of Care

Mixed Billing*

Not Applicable

Variations

If your department is part of the OnCore Financial Pilot, will this study utilize OnCore Financials for Sponsor billing?

Yes

Subject-related invoiceable procedures

List any subject-related invoiceable procedures that need to be added. For each, include which timepoint(s) they should be assigned to. If the procedure is invoiceable outside of protocol scheduled visits, list time point as PRN.

Examples:

Central lab collection, processing, and shipping @ Baseline, W1, W2, W4, E0T
Unscheduled Visit- Coordinator Effort @ PRN

Split procedures for invoicing

List any subject-related procedures that need to be broken down into 2 or more procedures for invoicing.

Example:

Safety Labs should be broken down into Chemistry, Hematology and Urinalysis

What type of calendar are you requesting?

Please consult with the study team/managers before making a selection.

Calendar Build Types Guidance

Minimum billing compliance calendar: minimum requirement; will only include procedures and visits with insurance billing risk for the University or the Hospital.
Visit inclusive billing compliance calendar: will include all visits but only procedures with insurance billing risk. For visits that don’t have procedures with insurance billing risk, a "Study Visit" procedure will be added so that all protocol specified visits appear on the calendar.
Full protocol calendar: will be built with all procedures and visits noted in the protocol regardless of billing risk.

Minimum billing compliance calendar

Visit inclusive billing compliance calendar

Full protocol calendar

Attach any materials to support the calendar build.

*Mixed Billing Studies: submit the PIs billing preference based on his/her assessment of conventional and/or medically necessary care. This can be in the form of a Protocol Schedule of Events with Research items circled or in a list form.
*Cooperative Group Studies: upload the Funding Sheet. Coverage analysis is not performed for services designated as Research.
*OnCore Financial Users: upload a list of additional Procedures for inclusion in the Subject Calendar that are not already listed on the protocol schedule of events. Use the OnCore Financial Standard Operating Procedures for further instruction.

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