Industry-initiated clinical trials and PI-initiated clinical trials are a subset of clinical research and 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.
All proposed industry-sponsored or -funded clinical trial agreements must be processed through OSR, regardless of any tentative understanding between the principal investigator (PI) and the sponsor. These procedures include completing an InfoEd Proposal Development (PD) record, which includes obtaining administrative approvals, and satisfying all other compliance requirements. Review by the department chair and administrative personnel is essential to ensuring that the University can provide the space and resources needed to conduct the project. No study subject related activity can be initiated until the contract is executed by OSR and IRB approval has been obtained.
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Costs/Fees to be Considered
- Advertising Fees
- Indirect Cost (F&A) Rate
- IRB Fees
- Regulatory Preparation Fee ($2500 minimum)
- Research Pharmacy Fees
- Other Study Start-up Fees
All direct costs with the exception of the IRB fees are subject to the indirect cost rate.
Confidentiality Disclosure Agreements (CDA)
A pharmaceutical, medical device, or other industry sponsor will typically send a CDA or other non-disclosure agreement (NDA) to the Principal Investigator. The investigator or her 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.
Clinical Trial Agreements (CTA)
After the CDA has been executed, the sponsor will send the protocol, CTA and proposed budget. Copies of these documents should be included in the InfoEd PD record along with the proposal routing form (PRF). The following documents are needed for submission:
- Draft or Final Protocol
- Draft or Final Budget
- Draft Clinical Trial Agreement
- Proposal Routing Form
- Draft or Final IRB consent
Negotiating the Contract: All contracts for industry-sponsored and -funded clinical trials are reviewed, negotiated and signed by OSR on behalf of the University and its employees. Please note that the 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.