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

The following is a general overview of the industry sponsored budget process; however, each CRU may have its own specific process and forms.
CRU led items are yellow, DOCR led items are green, misc items are grey.

CRU submits protocol shell in iRIS; syncs with Oncore

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

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 (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 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. 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.
  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