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Stage
Develop and Submit Proposal
Topic
Develop the budget and justification
Subtopic

Commercial or industry sponsored clinical trial budgets

Need assistance with industry sponsored budgets?

The task of developing budgets that support industry supported research is an activity involving:

  • Duke Office of Clinical Research (DOCR)
  • Duke Office of Research Contracts (ORC)
  • School of Medicine Finance office
  • Clinical Research Unit (CRU)

The CRU should be contacted first when industry supported research projects (clinical trial or clinical research) become available. 

Overview of the industry sponsored budget process

The following is a general overview; each CRU may have its own specific process and forms.
Yellow items: CRU led
Green items: DOCR led
Grey items: miscellaneous

CRU submits protocol shell in iRIS; syncs with Oncore

Access iRIS tip sheets.

CRU attaches final protocol and draft budget/contract in OnCore; requests study initiation meeting

An Internal Cost Assessment template can be used to draft the budget. Contact the CRU or GCA for assistance.

DOCR determines need for Protocol Calendar; attaches Task List

Access OnCore tip sheets.

 

DOCR creates Protocol Calendar; links to OnCore Charge Master

The Charge Master ensures clinical trial billing and budgeting align seamlessly with Maestro Care (Duke's instance of Epic).

DOCR/Budgeter completes appropriate tabs; creates preliminary budget workbook

CRU reviews budget and preps for study initiation meeting

Study initiation meeting is conducted; Protocol Calendar updated as needed

DOCR sends Protocol Calendar to team for review

CRU approves Protocol Calendar

CRU negotiates budget and payment terms 

Study initiation meeting must happen prior to this step

Access the Understand pre-award activities and spending page for guidance on obtaining pre-award spending approval, if needed.

CRU provides budget approval to ORC; copies DOCR and School of Medicine Finance Office

DOCR/Budgeter enters negotiated amounts; attaches executed contract in OnCore

Financial Practice Manager reviews Protocol Calendar and Financial Consoles before CRU sign-off

DOCR completes sign-offs; releases Protocol Calendar/Budget

Contracts

  1. CRU attaches the preliminary contract in OnCore.
  2. CRU sends the preliminary contract to ORC so that they may begin negotiations of the legal language.
  3. CRU reviews payment terms and contacts CRO/Sponsor to negotiate before study initiation meeting, if needed.
  4. After budget and contract are finalized, CRU obtains required signatures from Duke, PI and sponsor.
  5. Attach fully executed contract in OnCore.

 

Budgets

  1. CRU attaches the preliminary budget in OnCore.
  2. CRU negotiates budget with CRO/Sponsor.
  3. DOCR Budgeter creates budget and enters FPM-approved negotiated amounts in OnCore
  4. CRU enters and routes project in SPS, if have not already completed
  5. CRU Finance Manager completes the CRU Finance Sign-off in Oncore.

Notes for pricing

  • Research and Retail rates are in the OnCore Charge Master.
  • For the CPT codes not in the Charge Master, submit a completed PRMO Grant Pricing Request, via a Service Now ticket, with a comment (Procedure/event is not in the OnCore Charge Master).
  • For supplies not in fee schedule, send SAP number (material number), vendor and description to Revenue Manager.
  • For “bundled” procedures, request a bill of known patients who underwent the same or similar procedure from Revenue Manager.
  • For supplies not in fee schedule, send SAP number (material number), vendor and description to Revenue Manager
  • If using the IDS pharmacy, study teams are encouraged to make contact early in the planning process and provide detailed protocol information to obtain an accurate cost estimate. This proactive approach ensures that the study budget accurately reflects the necessary pharmacy services and facilitates smooth integration of IDS support into the research workflow.