Industry Clinical Research Agreement Process

Under the new process, the IBIS Agreement record will serve as the primary administrative record, eliminating the need for a separate Funding Proposal (FP) submission.

Quick Start Guide for Departments and Study Teams:

1. Confirm the project is an industry-funded clinical research project.
2. Create a Clinical Trial Agreement (CTA) record in IBIS.
   • [A new agreement type, Industry Clinical Research Agreement (ICRA), will be implemented in the future. Additional notice will be provided prior to its release.]
3. Upload the required documents:
   • Sponsor agreement
   • Sponsor budget
   • Internal Budget Template (if applicable)
   • Other documents needed for review and submission
4. Complete the required Departmental Approval through ancillary review.
5. Create the IRB record and upload available IRB documents.
6. Link the IRB record to the IBIS Agreement.
7. Assign the EDR-CTAT Ancillary Review.
8. Submit the Agreement with the CTAT ancillary review open.

If you are submitting an Amendment to an Industry Sponsored CTA (or SA) for an ongoing project, please submit the amendment to that agreement type following a similar process:

1. Confirm the project is an industry-funded clinical research project.
2. Create an Amendment within the applicable open agreement for said project (CTA or SA) record in IBIS *.
3. Upload the required documents:
   • Sponsor Amendment
   • Amended sponsor budget (if applicable)
   • Other documents needed for review (if applicable)
4. Assign the EDR-CTAT Ancillary Review.
5. Submit the Amendment with the CTAT ancillary review open.

Note:

• No activity is required within the FP/Grants Module.
• No additional Department Approval required for amendments (no need to create an Ancillary Review for Departmental Approval).

*ORA will be transitioning these ongoing CTA’s and SA’s into the new agreement type (ICRA) once the new agreement is available to allow for consistent tracking.

The resources below provide an overview of the new workflow, submission requirements, key responsibilities, and step-by-step guidance for departments and study teams. Please review these materials before submitting a new industry-funded clinical research project.

If you have any questions regarding the Agreement Process, please contact the Office of Research Administration at MRA@miami.edu.

If you have any questions regarding the Budget/MCA Process, please contact the Clinical Trial Activation Team (CTAT), EDRO at CTATBudget@med.miami.edu.