PI Initiated Clinical Studies
A clinical protocol written by a UTHealth faculty member(s), but funded by an Industry Sponsor.
If a Sponsor is making a direct payment of private funds for the purpose of a specific research project that is PI-initiated - regardless of whether the Sponsor calls it a grant, a contract, or anything else - you’re in the right place.
- The Investigator and the Sponsor agree on a Scope of Work
- A Budget is crafted to cover all costs of the Scope of Work
INTERNAL DOCUMENTATION REQUIRED
- Scope of Work/Protocol
- R&A Packet
- RCOI Forms
- IRB Approval, if applicable
- Other assurances (if applicable)
- Coverage Analysis, if applicable (This will need to be determined by SPA’s CRF Team)
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 our office in negotiations with the Sponsor, and assure that all potential compliance and conflict of interest issues are identified and addressed.
- Submit contract to SPA, if provided by Sponsor. Otherwise, SPA will draft it
- Submit Scope of Work
- Submit Protocol to the IRB
- Negotiate Budget with Sponsor (Send a copy of the final Budget to SPA)
- Complete Coverage Analysis form initiated by SPA- Submit to SPA
- Complete the R&A Form- Submit to SPA
- Complete the RCOI Forms- Submit to SPA
- Route the final (negotiated) b for PI Signature - Submit to SPA
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 to be cost sharing and must receive the appropriate prior approval.
- Negotiate the legal terms of the agreement with Sponsor on behalf of the PI and the University.
- Build out the coverage analysis shell for the study team to enter in costs, effort, and coverage information.
- Route the final agreement with the PI’s signature for the University’s Authorized Official to sign
- Contact Post Award to set up a financial account for the study. Once a copy of the fully executed agreement becomes available, and the department has submitted all of the internal documentation, Pre Award will contact Post Award Finance to set up a financial account for the study.