Externally Sponsored Clinical Trials
The Office of Sponsored Programs (OSP) supports the entire lifecycle of an externally sponsored project, from proposal submission to award closeout.
- Assists with proposal submission and reviewing the incoming award/contract.
- Assists in managing awards from account setup through closeout.
OSP Contacts are searchable by Pre-Award (Proposal Reviewers and Contract Negotiators) and Post-Award, as well as by Topic.
See guidance below for Routing to OSP and best practice advise on ensuring concurrent review by OSP, the Clinical Research Finance Office (CRFO) and the Institutional Review Board (IRB) to avoid delays.
Introduction Heading link
Routing to the Office of Sponsored Programs (OSP) Heading link
Best Practices Heading link
Before a Clinical Trial Agreement (CTA) can be executed, the protocol must have IRB approval and, as applicable, a Coverage Analysis by the Clinical Research Finance Office (CRFO). Aim for concurrent review by OSP, the CRFO and the IRB to avoid delays.
Please note a CTA can be submitted to OSP while the budget is under review. You can route a New Proposal through myProposals and include the draft budget and other supporting elements as described above (IRB Study #, Sponsor contact, draft Sponsor budget, internal budget, abstract, Informed Consent Form and CTA). This allows OSP to begin reviewing the terms of the agreement and work to engage the Sponsor on any items that require clarification. For industry sponsored CTAs, we understand the internal budget is based on best guestimate. The final budget that is approved by the Dept, CRFO, and Sponsor is included with the final CTA and shared with Post Award for account setup. If the draft budget is not available, you can submit a Pre-Proposal via myProposals which excludes the budget but includes the CTA and all other supporting elements to get review underway. An Award ID will be assigned and the OSP Contract Negotiator will begin reviewing the CTA. Upon finalizing the budget, a complete/New Proposal submission is required via myProposals which references the assigned Award ID before the CTA can be executed.
A great place to start is determining whether your study requires Coverage Analysis:
- “All Human subject research acknowledged by the UIC IRB by designation of a UIC protocol number and which utilize services or resources provided by the University of Illinois Hospital and Clinics, UIC College of Medicine office-based clinics, Mile Square Health Center, or Ryan White Infectious Disease Clinics (this includes both inpatient and outpatient services, including but not limited to ancillary services such as clinic visits, professional medical services, medical supplies, lab, pharmacy services, and imaging, whether for research purposes or standard of care) is required to have a Coverage Analysis and Itemized Study Budget.”
Before engaging the CRFO, an IRB Study ID is required first. The CRFO requires an IRB Study ID referenced in all communications and before submission to their office. (Note: IRB approval is NOT required before submission to the CRFO, only the assigned IRB Study ID upon submission).
- OSP can negotiate the terms of the CTA while the budget and IRB are under review. We can work to reach approved terms and confirm the subject injury reimbursement language that needs to be applied to the Informed Consent Form as consistent with the CTA.
- Continue to keep the OSP Contract Negotiator informed of the IRB Study ID assigned at submission and IRB approval status. IRB will hold approval for ancillary reviews by OSP for the subject injury language and the CRFO for the coverage analysis, as applicable.
- Clinical Research Finance Office (CRFO)
- Once a study is submitted to the IRB and an IRB Study ID is assigned, you can submit study documents to the CRFO for a Coverage Analysis and budget review.
Once we reach approved terms in the CTA and the Protocol is IRB approved, the CRFO will conduct a Final Reconciliation of the study documents, as applicable, before a CTA can be submitted for institutional signature.
Finding Your Contacts in Pre-Award and Post-Award Heading link
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