Utah Administrative Code
Topic - Health
Title R384 - Population Health, Health Promotion and Prevention
Rule R384-203 - Prescription Drug Database Access
Section R384-203-4 - Research Application Process
Universal Citation: UT Admin Code R 384-203-4
Current through Bulletin 2024-06, March 15, 2024
(1) The research facility designee will prepare and submit for Department approval an application as designated by the Department detailing explicit information regarding the scientific studies to be conducted including the:
(a) purpose of the study;
(b) research protocol for the
project;
(c) description of the
data needed from the database to conduct that research;
(d) plan that demonstrates all database
information will be maintained securely, with access being strictly restricted
to the designee and research study staff; and
(e) provisions for electronic data to be
stored on a secure database computer system with access being strictly
restricted to the designee and research study staff.
(2) Application will be reviewed by the Department's Institutional Review Board and recommendation made to the director for or against approval.
(3) Director will determine approval status of the application.
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