1-New Protocol Workflow in OnCore Materials

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2018 Symposium for Research Administrators

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OnCore New Protocol WorkflowNovember 7th 2018


Objectives

• To learn and understand the new protocol workflow in OnCoreincluding Task Lists, building a Protocol Calendar, linking of Charge Master events, Medicare Coverage Analysis and building a budget.

• To learn how to use OnCore Reports to create an internal cost assessment, to help strategize and plan for the budget negotiation process and to assist in portfolio management.


Speakers

• Angie Padget- Study Initiation ManagerDuke Office of Clinical Research (DOCR)

• Catee Mullen- Director, Clinical Research Financial Management

School of Medicine Finance Office (SOMF)

• Mark Ferguson- Grants and Contracts ManagerResearch Administration Support Resource (RASR)

• Tracy Kerby- Strategic Services Associate, Senior School of Medicine Finance Office (SOMF)


Go Live Facts

• Go Live: 5/21/2018

• Migrated all protocols from 1/1/2013 forward• In total, 16,000 protocols were identified for migration

• All Clinical Research • Closed or Open protocols• Exempt protocols • Retrospective chart reviews• Protocols enrolling non-Duke patients

• Pilot Group

• SAP Interface Go Live: Fall 2018


OnCore Hierarchy

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Calendars, Task Lists and Medicare Coverage Analysis

Angie Padget


New Study Startup Process

• Shortly after a new protocol has been submitted in Duke’s electronic IRB system, the study start-up team within the Duke Office of Clinical Research (DOCR) reviews the protocol to determine if the study will require a calendar

• Criteria: having a schedule of subject visits and/or any patient care activities that will generate charges within Epic (Duke’s electronic health record)

• The start-up team uses OnCore task lists to manage the request and receipt of information needed for the build process

• Drafts of sponsor budget and contract• Scheduling of study initiation meeting


OnCore New Study Task List


Protocol Review and Calendar Build

• Qualifying trial determination: Does the protocol meet Medicare’s standards for coverage?

• If not, all study-related activities must be paid for by the sponsor

• Identification of time points and clinical activities• Translating the protocol’s requirements into the specific tests and

procedures that will need to be ordered at Duke• Example: “Blood chemistry panel” in protocol = comprehensive

metabolic panel + magnesium + phosphorous at Duke

• Identifying charge assignments from budget

• Medicare Coverage Analysis of line items• Review of national and local coverage determinations


OnCore Calendar


Study Initiation Meeting

• The study start-up team meets with the principal investigator, study coordinators, and finance staff to clarify and validate:

• The clinical activities that will be performed• How charges should be assigned (research-only vs. routine care)• Necessary next steps in the institutional approval process

• The OnCore calendar is reviewed and accompanying budget requirements are discussed

• Once approved, the OnCore calendar status is changed to “Complete” and handed off to finance staff for completion of budget and approval


Institutional Approval

The goal is for the calendar and budget build to happen in parallel with IRB review and contract negotiations:

DOCR receives study documents via

OnCore

DOCR builds calendar and

reviews at study initiation meeting

DOCR calendar signoff and SOM-Finance budget

signoff

Institutional Approval

Budget available in OnCore for

editing and negotiation

Clinical Research Unit

Finance signoff

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Budgeting and Charge Master

Tracy Kerby


Before Building a Budget in OnCore

A protocol must have:

• A sponsor and

• A clinical calendar

Some financial parameters for a protocol are specific to one sponsor and can vary if multiple sponsors are involved with the study.

Costs are calculated for visits on the clinical calendar based on the procedures and labs scheduled for each visit.


OnCore Charge Master

• The Charge Master defines events that can be associated with a budget for a study.

• The Charge Master contains two types of events:

• Protocol Related: events that apply to a study, not to a particular subject or visit.

• Subject Related: events that are attributable to a specific subject and are associated with specific visits. These events include labs, panels, and procedures.

• Each event includes a description, identifying codes, and charge information.


Parameters

The Parameters tab is used to define the rules that will govern financials activities for a specific protocol, in order to lay the foundation for budgeting, setting milestones, invoicing, and tracking payments.

• Rate Base and Sponsor Settings

• Indirect Settings

• Budget Display Options

• Invoice Related Settings

• Invoicing Reminder

• Remit To/Bill To


Protocol Related Costs

Events that apply to the study, not to a particular subject or visit. Occur regardless of how many subjects are enrolled:

• Administrative Start-up• Advertising Fees• Duke Early Phase Clinical Research Unit, if applicable• Institutional Review Board (IRB)• Pharmacy, if applicable• Radiology, if applicable• Record Retention• Site Initiation Visit• Study Close-out• Study Team Meetings/Training


Subject Related Costs

Subject-related events are attributable to a specific subject and are associated with specific visits. These events include labs, panels and procedures.

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Budget Only Items and Reports

Mark Ferguson


Budget Only Items

Subject Related

events that should be in budget

Does not appear on

the Protocol or subject calendars

Defined in Charge Master

Appear in the Procedure/ Lab table,

indicated by an asterisk (*)


Budget Only Items

Can link to Visits/Schedules where

event applies

Examples: Dry ice, research team effort,

storage, shipping

+Can be invoiced in Oncore, if required.


Dept. Considerations

COMMUNICATION

What’s coming through the

pipeline.

TIMINGIRIS push.

TRAININGIn person, refreshers, experience

matters. CRCs.


Dept. Considerations

SOM FINANCE

Great resource, early stage so every question

matters, tip sheets, office

hours

DOCR START-UP MEETING

Attend, items in calendar, team

PRICINGUse Charge Master now,

different words, CPT codes,

bundling

MILESTONEs

(how you get paid), similar to

summary financial appendix


Budgeting Reports

• Rates Comparison Report • Side by side comparison. Get vs Need. In progress - next

Oncore update

• Budget Summary• By Arm, Negotiated rate, Retail rate, Research rate, +/-

indirects, per subject, startups, Protocol Related• Able to export and provide to Sponsor. Oncore format!

• Budget Calendar• Negotiated rate, Retail rate, Research rate, Procedures /

Events, indirects, similar to Sponsor templates, Duke Excel template

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Sign Offs and Approvals

Catee Mullen


Sign Offs

• SOM Finance Protocol Signoff• All protocols have this sign off• Routed for sign off after IRB approval

• CRU Finance Signoff• For projects with budgets• Sign off by CRU after the contract has been executed and fund

code has been entered in OnCore• Part of the Industry Funded Task List


Sign Offs

• SOM Finance Budget Signoff• Confirm the budget is set up correctly• Confirm fund code, G/L account and other attributes are correct for

SAP Interface

• DOCR CA/Calendar Signoff and Released• Completed by DOCR Start-Up team• Confirm Medicare Coverage Analysis is correct


Sign Offs

• Institutional Approval (IA)• DOCR completes• Includes confirmation the following items are complete:

• IRB approval• RDSP complete• CT.gov registration complete, if applicable• Maestro Care build complete• Contract executed

• Status of the above items are viewable on the Annotations page


Documents

1-New Protocol Workflow in OnCore Materials