Clinical Trial Agreements- UTHealth Investigator-initiated
What is an Investigator-initiated Clinical Trial?
A clinical trial for which the protocol was solely or jointly written by a UTHealth Investigator(s) but will be funded by a sponsor.
- If an industry sponsor is making a payment of funds for the purpose of a specific clinical trial protocol that is Investigator-initiated - regardless of whether the Sponsor calls it a grant, a contract, or anything else, the below likely applies.
- If an industry sponsor is requesting data, results, intellectual property, etc., in return for providing the industry sponsor’s material, equipment, etc., yet no funding is being provided for the purpose of a specific clinical trial protocol that is Investigator-initiated, the below likely applies.
PROCESS
- UTHealth PI creates protocol and, if applicable, a scope of work for a clinical trial.
- Coverage Analysis will be triggered by IRB review of the application submitted to iRIS.
INTERNAL DOCUMENTATION REQUIRED
- UT START Proposal Development Record
- UT START Agreement Record
- Protocol and, if applicable, a scope of work
- Budget/Budget Justification
- Or CAIB Tool (to go with budget/budget just.)
- IRB Approval
- IRB Approved Informed Consent, if applicable
- Coverage Analysis, if applicable (this will be determined via the IRB review of the protocol then sent to SPA’s CRFA team for processing)
- Other assurances, if applicable
- Approved IDC waiver**, if applicable
- Approval of cost-sharing, if applicable
- Disclosures of Conflicts of Interest (Project Disclosure & Annual Disclosure)
*Negotiations on the agreement cannot begin until these documents are submitted. The information provided in these documents will dictate what terms are needed in the agreement, assist SPA in negotiations with the industry sponsor, and assure that all potential compliance and conflict of interest issues are identified and addressed.
**Note: It is expected that UTHealth’s full indirect cost rate is reflected in the Budget. Any reduction or waiver of indirect costs is considered cost sharing and must receive the appropriate prior approval. https://www.uth.edu/sponsored-projects-administration/tools-resources/institutional-information
DEPARTMENT TASKS/RESPONSIBILITIES
- Ensure that industry sponsor agrees to the protocol proposed by the UTHealth PI
- Negotiate and come to agreement on the budget with the industry sponsor
- Submit protocol into iRIS for review by the IRB
- Create a proposal development record in UT START
- Create an agreement record (AGT) from the linkages tab to the proposal in UT START
- Create “Clinical Trial” AGT record to be reviewed and assigned to SPA Specialist
- Upload agreement, if provided by sponsor. If an agreement is not provided by sponsor, notify SPA via transfer e-form and SPA will draft the agreement
- Fill out the intake form under the “Agreement Info” and press “Submit” once complete. If you received an agreement draft from the other entity, you may upload that in the Intake Form or under the separate “Attachments” Tab
**Please note that pressing submit is essential for SPA to receive the request**
If you have any additional questions about Clinical Trial Agreements or the submission process, please reach out to [email protected].
SPA TASKS/RESPONSIBILITIES
- Negotiate the legal terms of the agreement with the industry sponsor on behalf of PI and UTHealth.
- If needed, build out the coverage analysis shell for the study team to enter in costs, effort, and coverage information. (Done by the CRFA team)
- Route the final agreement for review, approval, and signature, as applicable, to the PI and an authorized signatory for UTHealth.
- Confirm agreement has been fully executed, all appropriate documentation has been received, all applicable compliance elements have been obtained, etc.
- Update the status of the agreement record to “Fully Executed” in UT START.
- Submit proposal record to Post Award Finance (PAF) to set up a financial account for the clinical trial.