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Audit Checklists

The IRB uses the following checklists when conducting site audits of research studies. You are encouraged to review these checklists as needed to prepare for a site audit, or to help assist you as you maintain your research study documents. See IRB SOP 908: Routine and For-Cause Audits [PDF] for more information. 

Checklist Version Date

Audit Worksheets - ALL PAGES [PDF]
Audit Worksheets - ALL PAGES [DOC]

03.07.2011
Audit Worksheets Cover Page 03.07.2011
Audit Worksheet 1: Regulatory Documentation 03.07.2011
Audit Worksheet 2: Site Operations 03.07.2011
Audit Worksheet 3: Protocol Compliance 03.07.2011
Audit Worksheet 4: Informed Consent Documentation 03.07.2011
Audit Worksheet 5: Subject Records 03.07.2011
Audit Worksheet 6: Safety Monitoring 03.07.2011
Audit Worksheet 7: Drug and Device Accountability 03.07.2011
Pre-NSR Device Audit Checklist 02.04.2013

All documents are in PDF format unless otherwise noted.

Last Updated: 5/14/19