How To Start a Corporate Funded Clinical Trial Agreement (CTA

Follow the instructions on this page if you already have a protocol from the company and know you plan to go forward with the study. If you do not have the protocol yet, most companies will require a confidential disclosure agreement (CDA) before sending it. Click here for a guide to the CDA process.

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Overview

Getting to the point where you can start carrying out a corporate-funded clinical trial involves several negotiations, reviews, approvals and agreements. There are three sets of processes that fall into these groupings:

Contract Negotiation

Flowchart

Budget Negotiation

Flowchart

Budget Template 1

Budget Template 2

Items to Consider

IRB & Other Required Approvals

Human Subjects Office

Contract language review, negotiation, and ultimately signing are the responsibility of the Division of Sponsored Programs (DSP).  Most companies will send their preferred agreement to the University of Iowa for review, and DSP works from that. However, if a company asks you if we have contract terms, contact DSP, who can send the UI’s model clinical trial agreement. 

The following instructions will help you get started in working with the DSP and also provide some basic guidance on where to begin with the other processes, which are primarily the responsibility of the study team.

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How to submit your CTA for DSP’s review:

If you don't have access to UIRIS

 If you have access to UIRIS

  • Sign into UIRIS   
  • Open “Routing Form (University of Iowa Proposal Routing Form)”
  • You can “Begin a New Routing Form” or
  • “Begin a Routing Form from a Previously Submitted Form"
  • Answer each question on the electronic form on ALL pages/tabs:

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Routing Form Instructions

Instructions for the eRouting Form 

  • The following is the checklist of documents that must be attached prior to clicking “Submit”:
    • A copy of the CTA from the sponsor if available.  A Word version is preferred, but we can also accept a PDF of the CTA.
    • Budget, whatever level of detail is available at the time of routing.
    • Protocol.
    • Submission/shipping instructions from the sponsor, if available.
  • Click “Submit”

Additional eRouting instructions are available from eRouting at UI.

Please note the DSP cannot start negotiations of the CTA until all of the requested materials are sent.  When all requested materials are received, DSP will email you confirmation of receipt.

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Who does the Research Team contact if there are questions on completing the University of Iowa Proposal Routing Form?

  • If you have questions about the UI Proposal Routing Form, please call the DSP at 335-2123.

What happens after t​he DSP receives the CTA and Routing Form?

  • The DSP will notify you by email that all materials have been received.
  • The DSP will review the original CTA and may contact the PI or affiliated research professional for an initial consultation on the project.  The DSP will request additional information as needed and negotiate appropriate terms with the sponsor. 
  • When the CTA contract language and budget are agreed upon, the DSP will have the agreement signed on behalf of the University by the Director of Sponsored Programs, and the DSP will return the agreement to the Sponsor.
  • If the Sponsor requires a PI signature, the DSP will send it to the PI and research professional for PI signature before adding Institution signature.

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What should the Research Team do while the DSP is reviewing/negotiating the contract language? 

  • The PI and her/his delegate are responsible for negotiating the budget with a study sponsor. This occurs concurrently with the negotiation of the contract language by the DSP.  
  • Notify the DSP when the final budget is agreed upon
  • Submit IRB application
  • Submit other committee approvals
  • Submit sponsor/CRO requested regulatory documents

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Who negotiates the budget and when does this occur?

  • The PI and her/his delegate are responsible for negotiating the budget with a study sponsor. This occurs concurrently with negotiation of the contract language by the DSP.

IRB Approval 

When should the request for IRB approval be started?

  • The PI and her/his delegates should start the IRB process at approximately the same time as they submit the routing form and additional materials to the DSP.  Review by the IRB and ancillary committees can occur at the same time as CTA negotiations.
  • Contact the HSO for information related to IRB requirements.

Does the Research Team need IRB approval before submitting the University of Iowa Proposal Routing Form to the DSP?

  • No, review by the IRB and ancillary committees can occur at the same time as CTA negotiations.  It is preferable that these processes occur in parallel.

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Does the request for IRB approval go to the HawkIRB or WIRB?

  • In general, investigator initiated studies require HawkIRB approval.    Sponsor initiated studies (i.e., the sponsor’s protocol) require WIRB approval.   Refer to the UI Human Subjects Office (Form A checklist) for a specific determination related to your project.

What is required (what approvals must be in place) before the CTA can be signed?

What are some special circumstances that might apply in addition to those listed above?

  • There is a Conflict of Interest in Research that must be managed/approved by the Conflict of Interest in Research Committee. 
  • This is an investigator initiated study/protocol written by the UI PI.  Contact the UI Human Subjects Office for assistance regarding the additional FDA requirements for these studies.

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What happens after the CTA is fully signed?

  • When the agreement is fully signed and the Human Subjects Office authorizes the IRB to release approval documents , DSP will release the agreement to the UI Grant Accounting Office (GAO).  Once the GAO assigns the MFK (account number) for the study, the GAO will release the Award Activation Authorization Notice (AAAN) to the PI/department along with a copy of the fully signed agreement and the MFK.   

What happens if the Research Team gets IRB approval before the final contract is signed?

  • The IRB (either HawkIRB or WIRB) will not release the documents to the research team. There must be a final signed contract before the DSP can notify the Human Subjects Office to allow release of the IRB approval documents.

What is required (what approvals must be in place) before the AAAN and MFK (master file key or account number) can be issued?

  • The CTA must be fully signed
  • IRB approval must be obtained

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How does the Research Team check on the status of my CTA (ie, revision process, submission date to the sponsor)?

  • Check on the status of the CTA in the DSP Contract Log.  To request access to the DSP Contract Log, please send an email requesting access to uiris@uiowa.edu and put Contract Log Access Request in the subject line. If you’re an administrator or study coordinator, please copy your supervisor on the request. You will receive an email confirming that access has been granted, generally within 1 business day.  Requests for training and questions can be directed to Nathan Cook at uiris@uiowa.edu.
  • If you have further questions after viewing the DSP contract log, send an email to dsp-contracts@uiowa.edu. Please include the name of the PI, sponsor name, and DSP sequence number in your request for an update. DSP sequence numbers follow this pattern: C123400.

 

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