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] |
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 |
| IDE Pre-Assessment Checklist | 2022 |
| IND Pre-Assessment Checklist | 2022 |
| Pre-NSR Device Audit Checklist | 02.04.2013 |
All documents are in PDF format unless otherwise noted.