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Commercial or industry sponsored clinical trial budgets

Need assistance with industry sponsored budgets?

The task of developing budgets that support industry-sponsored research is an activity involving the Duke Office of Clinical Research (DOCR), Office of Research Contracts (ORC), School of Medicine Finance office, and the Clinical Research Unit (CRU).  When approached about an industry-sponsored research project (clinical trial or clinical research), contact your CRU.

    The following is a general overview of the industry sponsored budget process; however, each CRU may have its own specific process and forms.

    CRU submits protocol shell in iRIS; syncs with Oncore

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

    DOCR determines need for Protocol Calendar; attaches Task List

    DOCR creates Protocol Calendar, links to OnCore Charge Master

    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 (not before study initiation meeting)

    *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 SOMF

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

    FPM reviews PC and Financial Consoles before CRU sign-off

    DOCR completes sign-offs; releases Protocol Calendar/Budget

    Contracts

    1. Attach the preliminary contract in OnCore.
    2. Send the preliminary contract to ORC so that they may begin negotiations of the legal language.
    3. Read payment terms and contact CRO/Sponsor to negotiate before study initiation meeting, if needed.
    4. After budget and contract are finalized, obtain required signatures.
    5. Attach fully executed contract in OnCore.

     

    Budgets

    1. Attach the preliminary budget in OnCore.
    2. The CRU-assigned Budgeter develops budget* in OnCore.
    3. Negotiate budget with CRO/Sponsor.
    4. CRU-assigned Budgeter enters FPM-approved Negotiated amounts in OnCore
    5. Enter and route project in SPS, if have not already completed
    6. 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