Working with DSP on a corporate-funded clinical trial agreement

  • CDA first. Most companies will require a confidential disclosure agreement (CDA) before sending a protocol. Click here for a guide to the CDA process.
  • Route the CTA to DSP. 
    • Click here for a flowchart of DSP’s CTA process.
    • Route the CTA to DSP prior to submitting the IRB application.
      • The routing form must receive all approvals, and be released by DSP’s intake team, before the funding source can be linked in the IRB application.
    • Most companies prefer their own contract template. If needed, DSP can provide a template. 
    • These attachments are required for DSP to begin a review:
      • CTA template (Word version preferred)
      • Protocol
      • Draft internal budget
      • Sponsor/CRO contact information
  • Simultaneous reviews: 
    • While DSP is negotiating the contract language:
      • Budget negotiation: the department’s budget analyst is responsible for negotiating the budget with a study sponsor. Send DSP a copy  of the final budget and final internal budget when ready.
      • Submit IRB application
      • Submit other committee approvals
      • Submit sponsor/CRO requested regulatory documents
    • Conflict of Interest in Research compliance review is initiated automatically once the routing form is submitted. 
  • DSP approval in HawkIRB
    • DSP will put its approval in HawkIRB after contract terms are final. This approval date does not mean the budget is final or that there is a fully signed contract.
    • Exercise caution to ensure cost recovery prior to a fully signed contract and award notice / MFK.
    • For questions about the status of an agreement, contact 
  • Signatures 
    • The CTA can only be signed after budget and contract negotiations are complete and final, and COI compliance is approved. 
    • DSP will work with the Sponsor to determine the CTA signature process and will obtain all UI signatures.
  • Awarding & Master File Key (MFK)
    • After IRB approval is released, DSP and Grant Accounting will issue the award notice (AAAN) and Master File Key (MFK).
    • Contact if you have IRB approval and have not yet received your MFK.

Indirect costs and payment terms

  • F&A rate for corporate-funded clinical trial agreements:
    • The University's F&A rate for CFCTs is 30% of total direct costs. 
    • Non-interventional studies, including observational, registry and retrospective chart reviews, are generally not considered CFCTs for purposes of the University’s F&A cost rate
    • See DSP’s F&A Costs page for more information.
  • Payment terms in clinical trial agreements:
    • The department budget analyst and DSP are responsible for reviewing payment terms.
    • Budget analyst will review and negotiate:
      • Subject enrollment targets
      • Invoicing requirements and deadlines
      • Withholding percentages
      • Screen failures
      • Fees (IRB, storage, advertising, etc.)
    • DSP will:
      • Enter payee information (bank account, EIN, etc.)
      • Review to confirm the terms in a payment exhibit for consistency with UI policies and the contract.

Master Agreements

Master Agreements can save time if the University of Iowa will work with a sponsor repeatedly. Most of the contract terms are contained in the Master Agreement; study-specific terms and budgets are negotiated separately in a Work Order (or similar).

  • Existing Master Agreements: To view a list of sponsors who have signed a Master CDA or CTA with the University of Iowa: 
  • Routing a new study under a Master:
    • CDA: a Protocol Addendum (or similar) is still required under a Master CDA. Route to DSP on a non-monetary routing form.
    • CTA: route a Work Order (or similar) on a monetary routing form, with the Protocol and internal budget.
  • New Master Agreements:
    • Contact with the draft agreement (if sponsor provided one) and sponsor contact information

Contract amendments

  • When a sponsor issues a protocol amendment, there is not automatically a contract amendment. Route to DSP when there is a contract amendment.
  • An amendment may revise substantive terms of the CTA (for example, changes the budget, project period, or the PI).
  • When routing, indicate if the amount awarded on the study’s MFK to-date is changing (increasing, decreasing, or not changing). Include an internal budget reflecting the changes.

Agreements associated with a clinical trial 

The agreements below can be associated with a clinical trial. Check with DSP if a new routing form is required.

  • Study Start-up Agreement
  • Payee / Beneficiary Details Form
  • Investigator Agreement or consent
  • Quality Agreement
  • Letter of Indemnification
  • Power of Attorney
  • Consulting Agreement
  • Data Use Agreement
  • Material Transfer Agreement
  • Outgoing subaward

Frequently Asked Questions

  • Who is negotiating my CTA? What is the status of my CTA?
  • How long does it take to negotiate a CTA?
    • CTAs can take 6 – 8 weeks to negotiate. The length of time varies depending on the complexity of the agreement, responsiveness of the sponsor and the volume of work pending in DSP.
  • Does the University of Iowa have non-negotiable terms in CTAs (e.g., indemnification, subject injury)?
    • The terms required in a CTA depend on the nature of the study and the type of funder. DSP will negotiate appropriate terms, including any provisions required by the UI Policy Manual.

Reviewed March 2024