This template is appropriate for studies involving FDA-regulated products. It is also recommended for any other study in which external parties (such as sponsors or collaborators) will receive study data that has not been fully de-identified according to HIPAA standards. *
This template should be used for
internal studies and for other projects where all data released
to external parties has been de-identified according to HIPAA
standards. *
Approval for a humanitarian use device (HUD) involves special considerations from FDA and the HSC. Please contact the HSC Office for more information when proposing the use of an HUD.