Dell Medical School

Clinical Trial Agreement

Go To: Main Office of Research Site

Clinical Trials Email: DellMedClinicalTrials@austin.utexas.edu
Download a Clinical Trial Agreement Checklist or click each step below.

Submit Proposal Notification Form to serve as pre-notification to our office if interested in participating in a clinical trial.

Enter the clinical trial study into UTRMS using the guidelines on the Dell Med Agreement Submission Portal intranet page to add administrative staff, and including the following items in Supporting Documents:

  • Protocol – final version
  • Clinical Trial Agreement
  • Sponsor’s budget (if available)
  • Informed consent draft
  • Study manuals (if applicable i.e. lab, pharmacy, shipping)
  • IND/IDE letter (if applicable)


Email DellMedClinicalTrials@austin.utexas.edu with:

  • UTRMS number
  • Ascension Seton SAT CR Number (if applicable and available)
  • Sponsor contact information
  • Budgeting Worksheet/MCA (formerly known as Coverage Analysis Worksheet (CAW)) ^(required for all studies, even those just at Dell Med) This will be found at the bottom of the SAT submission tool and will have the most recent version as an attachment saved as "MCA & BUDGET..."
  • Anticipated enrollment number
  • Anticipated length of study from enrollment to closeout
  • Study IRB (specify UT IRB or name of Central/External IRB)

^If study involves Ascension Seton make sure to use the most updated version of the Budgeting Worksheet/MCA (formerly known as Coverage Analysis Worksheet (CAW)) posted on the first page of the SAT.

Read about Dell Med Clinical Trial Budget Documents
See the Dell Med Clinical Trial Fee Schedule
State regulations prohibit UT employees from agreements to perform any work or from negotiating the costs of any work outside of the Sponsored Projects Administration process therefore Dell Med PIs should refrain from discussing any specific costs with the sponsor. They can communicate around Sponsor’s desired max budget and suggested costs but should not agree to any cost structure or commit the University to any work.

Process for Executing a Clinical Trial Agreement

Clinical Trial Agreement Process v1

➜ Clinical Trial Agreements Process Overview

  • The Clinical Trial Agreement (CTA) negotiation process includes two separate work-flows conducted by the Dell Med Office of Research (OOR) that are combined at the end of the negotiation process into one document for institutional signature. The first component involves the negotiation of the substantive terms of the clinical trial agreement (CTA), while the second involves the negotiation of the associated study budget.
  • CTA negotiation and budget review will typically occur concurrently.
  • The Office of Research (OOR) Contracting Unit will begin the negotiation process for the CTA once the CTA --or a request for one-- has been submitted through UTRMS using the guidelines on the Agreement Submissions Portal intranet page with the information requested on the Clinical Trials Agreement Checklist.
  • The OOR Contracting Unit will review and comment on the CTA (as necessary) and provide proposed edits to the other contracting party (typically the sponsor). Please make sure to include contracting party contact information when submitting through UTRMS using the Agreement Submissions Portal.
  • The OOR Sponsored Projects Administration Clinical Budget Unit will begin its budget review when the information requested on the Clinical Trials Checklist is provided to DellMedClinicalTrials@austin.utexas.edu.
  • Please provide a draft of the Budgeting Worksheet/MCA (formerly known as Coverage Analysis Worksheet (CAW))for all studies, including those that do not involve Ascension Seton.
  • Budget review and negotiation will begin upon review and approval of the Budgeting Worksheet/MCA (formerly known as Coverage Analysis Worksheet (CAW)). A first draft of the Sponsor Budget with negotiation targets will be shared with the PI/study team at this time.
  • If applicable, Ascension Seton (Seton) will reach out to the study team, the study team responds to Seton inquiries, then Seton sends their charges for study time or services to the OOR Sponsored Projects Administration Clinical Budget Unit.
  • When budget negotiations are nearly final, approval from the PI is sought on the proposed Sponsor Budget and associated Internal Budget document.
  • After the PI approves, the Sponsor Budget will be combined with the draft CTA and finalized with the sponsor. The OOR Contracting Unit will obtain institutional signature through the main campus Office of Sponsored Projects (OSP). The PI will be requested to sign as reading/acknowledging the final CTA including the final Sponsor Budget. The PI should not sign anything until requested by OOR staff.

Some additional considerations:

  • You will need to have IRB approval and Seton approval (if applicable) in order to begin enrollment on your clinical trial.
  • Any issues that arise during contract or budget negotiations will be shared with the PI and study team. To obtain necessary approvals, departmental and research domain executive leadership may also be consulted.
  • OSP requires IRB approval or PI acknowledgement that the study will not enroll until IRB approval has been obtained before OSP will sign the CTA.

If you have any questions on either the CTA or budget, please contact the Clinical Trials Contact email at DellMedClinicalTrials@austin.utexas.edu

Click here to download a PDF of the Process for Executing a Clinical Trial Agreement FlowChart.