Reportable Events

Effective date: 8/1/2017

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Brief Overview

UT Southwestern (UTSW) reportable event requirements apply to all non-exempt human research conducted by or on behalf of UTSW and its affiliates, and by investigators, sites, and institutions relying on the UTSW IRB. Investigators relying on an external (non-UTSW) IRB who are conducting research on behalf of UTSW or its affiliates are still responsible for submitting certain local events to the UTSW IRB. For more details on investigator responsibilities, refer to the Reportable Event Guidance within the HRPP Policies and Procedures.

HRPP/IRB Guidance and Forms

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References and Additional Guidance

Food and Drug Administration (FDA)

NIH Office of Biotechnology Activities (OBA)

Office for Human Research Protections (OHRP)

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Updated: 8/30/2017