3.2 Data and Safety Monitoring

1.0 Purpose

The purpose of this policy is to describe the Organization’s requirements for data and safety monitoring for non-exempt research.


2.0 Policy

It is the policy of the Organization that all non-exempt research must have an appropriate plan for data and safety monitoring in consideration of the nature and risk level of the research. The Data and Safety Monitoring Plan (DSMP) may or may not include a formal Data and Safety Monitoring Board (DSMB).


3.0 Data and Safety Monitoring Plan (DSMP)


4.0 Data Safety Monitoring Board (DSMB)


5.0 Review of the DSMP by the IRB


6.0 Review of DSMB Reports by the IRB


DOCUMENT HISTORY:

 Written: 4/4/2016 (Approved: 4/4/2016) - original author not recorded

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

 Revised 12/22/2022 – Clarified expected contents of DSMP; other revisions to eliminate duplicate text and for clarity. {Approved Chris Kratochvil (Institutional Official), Bruce Gordon (Assistant Vice Chancellor for Regulatory Affairs, Executive Chair)}

 Board notified - 12/29/2022


Revision #6
Created 24 October 2019 21:30:20 by Autumn M Eberly
Updated 6 January 2023 20:13:11 by Robert A Lewis