Clinical Trial Agreements
About Industry Clinical Trials
Industry clinical trials include industry-initiated clinical trials, PI-initiated clinical trials, and non-interventional clinical research. The clinical trial indirect cost rate is applied to clinical studies that meet all four of the following criteria, without exception:
- 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 Northwestern Sponsored Research office 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 Sponsored Research for review and signature. After the CDA has been executed, the sponsor will send the protocol, CTA, and proposed budget.
Submission to SR
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, Sponsored Research 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 Initiation
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 Northwestern Sponsored Research.
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Clinical Trial award set-up will transition from the Sponsored Research Contracts & Negotiations team to the Awards Management team effective January 23, 2023. These awards will be processed by award management associates based upon capsule constituencies.
As a reminder, clinical trial awards require a budget broken out into three components:
- Per subject enrollment/capitation costs: Per subject dollars x the estimate (or authorized quantity) of subjects, e.g., $1200 per subject x 20 subjects = $24,000. This per subject value must be inclusive of indirect costs. Trials with a cap on the number of subjects should be calculated at that cap. Trials with open enrollment and no cap on the number of subjects should include an estimate of the total number of subjects for the full project period.
- IRB related fees, exclusive of F&A, e.g., initial application, modifications, continuing review, compliance maintenance, reportable events, study closure.
- Other costs, inclusive of F&A, that are not part of the per subject enrollment amount, e.g., start-up fee, pharmacy fees, CRU fees, initial and recurring/annual maintenance fees, archiving fee, study closeout fee, etc.
NOTE: F&A is calculated at 32% on all patient/study costs with the exception of IRB fees.
A Clinical Trial Award Budget Form is provided to enter these categorical costs with autofill of the total costs. The budget form must be uploaded into the InfoEd (soon to be CERES) record for SR award set-up activities.
Questions may be directed to Michael Ferguson, Director, Awards Management.