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.
OSP Pre-Award
- Assists with proposal submission and reviewing the incoming award/contract.
OSP Post-Award
- 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
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Introduction
The University of Illinois Chicago (UIC) has been awarded Full accreditation from Association for the Accreditation of Human Research Protection Programs, Inc. (AAHRPP). This achievement recognizes the efforts of the UIC research community to ensure sustained excellence and commitment to protecting the rights and welfare of research participants with the highest ethical and professional standards. While UIC has a robust clinical trial review process, streamlining efforts continue in order to get studies up and running.
UIC clinician scientists are engaged in a wide variety of clinical trials investigating new approaches to preventing and treating conditions and diseases. The variety of therapies being studied range from new pharmaceutical drugs and medical devices to behavioral and biotechnology therapies.
The Clinical Trial Agreement (CTA) is a contract between at least two entities which outlines the obligations for research directly involving human subjects that is designed to evaluate the safety and effectiveness of new drugs or devices or of behavioral interventions. Such research may be conducted under an industry-developed protocol or an investigator-developed protocol.
The Office of Sponsored Programs (OSP) will review the CTA and work towards finalizing the terms with the Sponsor. UIC, like other public research universities is subject to an increasing number of state and federal regulations that are unique to higher education. As a result, most contracts provided by our sponsors require revisions before we can legally sign them. The Open Letter to Sponsors for Clinical Trials provides a summary of the most common provisions negotiated in clinical trial agreements.
- If the Sponsor is amenable to streamlining negotiations, the University is a Participating Institution and proponent of the Accelerated CTA (ACTA).
- The ACTA was created in a joint effort in 2014 by twenty-five Clinical and Translational Science Award (CTSA) institutions. The University and Industry Demonstration Partnership (UIDP) partnered with the CTSA group to increase awareness of the ACTA. The ACTA is designed to create a standard agreement between sponsors and academic institutions to reduce contract negotiations for industry sponsored multi-site studies.
Master Clinical Trial Agreements (MCTAs) provide agreed-upon terms and conditions establishing the basic relationship between the University and a Sponsor to be used for clinical trials with that sponsor moving forward. The use of a MCTA is a key tool in getting studies up and running as quickly and easily as possible by alleviating the need to negotiate individual agreements for future trials with that sponsor. OSP and University Counsel are continually working on revisions, renewals, and/or new MCTAs.
Often Sponsors request that a Non-Disclosure Agreement (NDA), sometimes also called a Confidential Disclosure Agreement (CDA), be implemented to ensure confidentiality of proprietary data that the Sponsor gives to Investigator in order to make a determination as to whether or not he/she will participate in a clinical trial. NDAs are also commonly executed when two parties are considering pursing a relationship together and need to understand the other’s processes, methods, or technology solely for the purpose of evaluating the potential for a future relationship. These agreements, if required, should never be signed by the Investigator and should be always be forwarded to OSP to negotiate and have executed by the appropriate institutional official as described below.
- OSP can negotiate appropriate terms on behalf of the Investigator and University, or offer a Reciprocal Non-Disclosure Agreement. The Agreement can be submitted to OSPWeb with the appropriate Intake Form.
Should you have questions about a CTA or NDA, contact the Office of Sponsored Programs via email at awards@uic.edu or phone 312-996-2862. OSP contract negotiators responsible for reviewing CTAs are Brenda Barrie (bbarrie@uic.edu) and Kevin Wleklinski (kevinw@uic.edu).
- If the Sponsor is amenable to streamlining negotiations, the University is a Participating Institution and proponent of the Accelerated CTA (ACTA).
Routing to the Office of Sponsored Programs (OSP) Heading link
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New Submissions
New submissions are made via myProposals and should include:
- The Sponsor contact (Bonus: upload correspondence from the Sponsor with appropriate contacts/Sponsor reference #)
- IRB Study ID (if one has already been assigned, or email this to the contract reviewer upon receipt)
- Sponsor budget
- Internal budget (For industry Sponsored CTAs, this is the best guestimate based on projected enrollment)
- Abstract/summary/scope of work (vs the entire protocol)
- Draft informed consent form
- Draft Clinical Trial Agreement (CTA) from the sponsor (MS Word version) if the sponsor provided their template
Template Agreements
Template Agreements
- Accelerated Clinical Trial Agreement (ACTA)
- Investigator-Initiated Accelerated Clinical Trial Agreement (PI Initiated ACTA)
- Reciprocal Non-Disclosure Agreement
- Open Letter to our Sponsors for Clinical Trials provides a summary of the most common provisions negotiated in clinical trial agreements. UIC, like other public research universities, is subject to an increasing number of state and federal regulations that are unique to higher education. As a result, most contracts provided by our sponsors require revisions before we can legally sign them.
Amendments
OSP Submission of a CTA Amendment ideally includes:
- The Sponsor contact (include correspondence from the Sponsor for contact purposes and to relay any instructions)
- Current IRB approval letter
- Revised internal budget
When to Route to myProposals vs OSPWeb:
- If the Amendment provides additional funding that is not captured in the initial proposal, please submit via myProposals as a Supplement/Amendment to the existing record
- If there are no additional funds or the CTA was received after proposal submission, please submit via OSPWeb
Tip: See the When to Route to MyProposals vs OSPWeb
Please note the PI or designee is required to submit a Coverage Analysis Amendment Summary Form to the CRFO at researchfinance@uic.edu any time there are amendments to the CTA, Budget, Protocol, or Informed Consent Form. The CRFO will issue a revised draft Coverage Analysis (or revised Final as applicable) within 15 business days of receipt.
Best Practices Heading link
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New Submissions
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
- 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.
- IRB
- 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
Resources Heading link
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Internal Resources
- Releasing Epic information to Study Monitors – Tip Sheet for releasing information to Study Monitors
- Sign up for OSPNews Subscription Request to learn about upcoming Research Administrator’s Meetings (RAM). View past RAMs under Education and Training.
- OSP offers weekly Open Labs to address any question you may have about the sponsored project process at UIC. These sessions are fully customizable to your dept needs and designed to provide one-on-one assistance on a range of topics.
- Visit the Center for Clinical and Translational Science (CCTS) to learn about upcoming Best Practice Hour Seminars.
- Find OSP Contacts searchable by Pre-Award (Proposal Reviewers and Contract Negotiators), as well as Post-Award by Topic.
- Search for the assigned Post-Award Specialist by Grant Code to find the individual who manages your grant or contract.