About Industry Clinical Trials
Industry-initiated clinical trials and PI-initiated clinical trials, along with non-interventional clinical research, must meet all four of the following criteria in order to qualify for the clinical trial indirect cost rate:
- The objective of the study is either:
- testing of drugs, devices, diagnostics, treatments, interventions, or preventive measures including testing for an unapproved indication; or,
- data collection to increase knowledge that would lead to enhanced safety and efficacy of a drug or device.
- The study must involve contact with humans. Studies involving medical chart reviews qualify as having contact with human research participants.
- The study must be performed primarily in patient care areas and qualify as an off-campus project.
- The study must be sponsored or funded by industry.
Executing a Clinical Trial Agreement (CTA)
Regardless of any tentative understanding between the principal investigator (PI) and the sponsor, all industry-sponsored clinical trial agreements (CTA) must be reviewed, negotiated, and signed by the Office for Sponsored Research (OSR) on behalf of the University.
A pharmaceutical, medical device, or other industry sponsor will typically send a confidentiality disclosure agreement (CDA) or other non-disclosure agreement (NDA) to the Principal Investigator. The investigator or their staff should send any CDA or NDA they receive from an industry sponsor to the appropriate Contract and Grants Officer in OSR for review and signature. After the CDA has been executed, the sponsor will send the protocol, CTA, and proposed budget.
Submission to OSR
For any proposed industry-sponsored clinical trial agreements, the department should create an InfoEd Proposal Development (PD) record. In addition to a completed proposal routing form, OSR requires the following documents for review:
- Draft or Final Protocol
- Draft or Final Budget
- Draft Clinical Trial Agreement
- Draft or Final IRB consent
Negotiation and Study Intiation
A final contract can only be signed when negotiations are complete, the InfoEd PD record is complete, Financial Conflict of Interest (FCOI) updated/approved for all key personnel, and IRB approval has been obtained. These steps can be done concurrently. No study subject-related activity may be initiated until the contract is executed by OSR.
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