3.14 Phase I and First-in-Human Studies

Last Revised: 2/5/2018

1.0 Purpose

The purpose of this policy and procedure is to describe the Organization’s requirements for IRB review and approval of Phase I and First in Human Studies.


2.0 Policy


3.0 Definitions


4.0 General Principles


5.0 IRB Review



7.0 Phase I Studies in Children


8.0 Phase I Studies in Decisionally Impaired Persons


DOCUMENT HISTORY:

 Written: 2/5/2018 (Approved: 2/5/2018) - original author not recorded


Revision #9
Created 24 October 2019 21:34:15 by Autumn M Eberly
Updated 17 April 2025 15:58:30 by Robert A Lewis