RECLASSIFICATION OF FEDERAL CLINICAL TRIALS

Effective with new funding received on or after July 1, 2019, UCSF administrative offices will categorize federally-funded Clinical Trials as Organized Research. This change is the result of an impact analysis and survey of UC campuses with medical centers following a review of the October 2014 revision by the National Institutes of Health (NIH) to its definition of Clinical Trial.

  1. The survey of UC campuses with medical centers revealed that all except UCSF currently classify federally-funded clinical trial awards in the Organized Research direct cost base and apply the Organized Research indirect cost rate. UCSF currently categorizes federally-funded Clinical Trial awards in the Other Sponsored Activities direct cost base, subject to the non-research indirect cost rate.
  2. The impact analysis illustrated the need for UCSF to mitigate new administrative burden on the UCSF research community, which can be achieved by reclassifying federally-funded Clinical Trials as Organized Research.

By reclassifying federally-funded Clinical Trial awards as Organized Research, UCSF will be consistent with treatment of federally-funded Clinical Trial awards system-wide. Additionally, the reclassification will reduce administrative burden by eliminating the need to implement complicated internal guidance for faculty and staff, as well as justifications to agencies, in order to navigate the difference between UC’s definition of Clinical Trial and the revised NIH definition.

Effective with new funding received on or after July 1, 2019, UCSF administrative offices will apply the Organized Research indirect cost rate to all on-campus, new, renewal, resubmission, revision and transfer-in applications. Applications in process and submitted prior to July 1, 2019, which cannot be revised and associated awards, will honor the proposed Other Sponsored Activities indirect cost rate and will not be affected by this change.

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