7.3 Data Registries

Last Revised: 4/16/2025

1.0. Purpose

The purpose of this policy is to describe the Organization’s requirements for creation and operation of a data registry, and for research use of data from a registry.


2.0. Policy

It is the policy of the Organization that


3.0. Definitions


4.0. ORA and IRB Responsibilities


5.0. Investigator Responsibilities


6.0. Research Use of Data from a Registry


DOCUMENT HISTORY:

 Written: 1/14/2016 (Approved: 1/14/2016) - original author not recorded

 Revised: 3/2/2018 - revision not documented

 Revised 4/16/2025 - Revised definition of data registry to be inclusive of non-clinical registries; restructured policy to focus on responsibilities of investigators and IRB/ORA; deleted description of processes more appropriate for SOPs; stylistic changes


Revision #7
Created 24 October 2019 21:43:04 by Autumn M Eberly
Updated 14 May 2025 19:20:19 by Robert A Lewis