Clinical Research Support

Regulatory Requirements

We encourage PIs or research staff to contact Regulatory Affairs in advance when they are developing/submitting non-industry sponsored new studies with any of the following characteristics:

 

  • Study will be conducted under a new IND or IDE to be submitted by the PI or another individual at Fred Hutch/UW.

  • Study will evaluate one or more approved drugs in a way that is not specifically described in the FDA-approved package insert (e.g., different indication, dose, schedule, combination, combining with radiation, etc.).  This type of study may require an IND or determination of IND exemption.

    • Note: Standard clinical use of approved products in an oncology setting does NOT always specifically reflect the approved labeling.  RA should be contacted if the study use differs from labeling, even if it is based in established clinical practice.
       
  • Study will evaluate a device, including in vitro assays or use of cell selection (e.g., Miltenyi CliniMACS system).

  • Study will evaluate stem cell transplant for treatment of disease other than hematologic malignancies.

     

It is also useful for Regulatory Affairs to be notified of the following:

  • Study has IND exemption confirmed by the FDA.

  • Study will be conducted under an existing IND or IDE held by the PI or another individual at Fred Hutch/UW.

  • Study will be conducted under an IND held by an investigator at another institution, or held by another academic/research institution.
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