• 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 dsp-contracts@uiowa.edu 
• 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 dsp-contracts@uiowa.edu if you have IRB approval and have not yet received your MFK.

• 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 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: 
  • https://dsp.research.uiowa.edu/types-contracts-and-model-contracts
• 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 dsp-contracts@uiowa.edu with the draft agreement (if sponsor provided one) and sponsor contact information

• 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.

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

• Who is negotiating my CTA? What is the status of my CTA?
  • Check DSP’s research tracker.
• 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.