April 23, 2025

New Industry Sponsored Clinical Trial Definition and F&A Rate – Effective July 1

The definition of an industry sponsored clinical trial and the associated Facilities & Administrative (F&A) rate at the 91探花 have not been updated in well over a decade. To bring the 91探花in line with our peer institutions, including other medical centers, and to address associated costs of running trials, we are implementing the following adjustment to the F&A rate and to the clinical trial definition to increase the number of studies that will receive the new rate.

Effective July 1, 2025, the industry-sponsored clinical trial definition and associated F&A rate will be updated as follows. Please review guidance on planning ahead for these updates.

UW鈥檚 New Industry Sponsored Clinical Trial Definition

A human subjects research study whose primary purpose is to assess the safety and/or efficacy in humans of a drug, device, diagnostic, treatment, preventive measure, or similar intervention through testing of the intervention on patients in a clinical setting. These studies are most often conducted in conjunction with obtaining new drug or device approval from the U.S. Food and Drug Administration (FDA), Phases I-IV.

Studies that are not Phase I-IV, but where all factors listed here are met, also qualify as an industry sponsored clinical trial:

  • Sponsored by industry (direct or originating);
  • A prospective study involving human subjects assigned to an intervention;
  • Use of 91探花Medicine facilities, clinical services or clinical space, including affiliated
    facilities, e.g. Fred Hutchinson Cancer Center, as a site;
  • Requiring an IRB-approved protocol, AND
  • The study:
    • Evaluates the safety and/or efficacy of non-FDA regulated drug, device, treatment or diagnostic, or
    • Evaluates an FDA-approved drug or device, and contributes to medical knowledge about the treatment of a disease or medical condition.

New Industry Clinical Trial F&A Rate

Studies that fall into the scope of the new definition will use a 35% Total Direct Cost (TDC) rate.

Applying the New Definition & Rate

All NEW studies that fall under the new trial definition routing through SAGE on an eGC1that fall and are 鈥淐ompleted鈥� in SAGE 鈥溾�� by July 1st or later must use this rate. eGC1鈥檚 using an old or wrong rate that arrive 鈥淚n OSP鈥� status that show a 鈥淐ompleted鈥� date later than June 30th will be returned to the PI for correction.
Amendments to existing studies that are in place at the 91探花and already using the 27% rate will continue to use the 27% rate.

Plan Ahead!

If you are a PI or a study team planning to initiate an industry-sponsored clinical trial, please consider the timing of this change to make sure the correct budget and rate are included in accordance with this guidance. When putting together your initial budget information for submission in RedCap for review by the 91探花Clinical Trials Office (CTO), use the new definition and rate if you anticipate the eGC1 in SAGE to be routing on or after July 1, 2025.

If the eGC1 is routed to OSP before July 1st, continue to use the current 27% rate. You will not have to renegotiate or update the budget if the eGC1 is in the following SAGE statuses by June 30th, 2025: Routing, IN OSP, Approved.

Please note that for all studies falling in scope of the new clinical trial definition, the submission of the institutional REDCap Study Intake form will be required prior to routing the eGC1. The study RG identifier (also known as RG number) must be included in the Short Title field in SAGE (e.g., RG1129999: Phase 3 Novartis MS Study).

Please refer to the FAQs to help answer the questions that you may have.

For additional questions about the new definition or the F&A rate, please contact osp@uw.edu or uwcto@uw.edu.

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