HRPP Policy - Humanitarian use devices

About This Policy

Effective date:
07/19/2018
Last updated:
01/19/2021
Policy Contact:

IU Human Research Protection Program (HRPP)
(317) 274-8289
irb@iu.edu

7.0 - Definitions related to this policy

adverse events, audit, clinical investigation, device, humanitarian device exemption (HDE), humanitarian use device, institutional review board (IRB), investigator, noncompliance, reportable event

 

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