697271
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- October 21, 2010
- Fiscal Year
- 2011
- Product Type
- Devices
- Project Area
- Bioresearch Monitoring
- Location
- Marquette, MI (United States)
Additional Details
IRB
Citations
| ID | CFR | Description |
|---|---|---|
| 7281 | 21 CFR 56.108(a)(1) | Initial and continuing reviews |
| 7290 | 21 CFR 56.108(c) | Members present for review |
| 7305 | 21 CFR 56.110(b)(2) | Minor changes |
| 7317 | 21 CFR 56.115(a)(1) | Copies of all research proposals and related documents |
| 7318 | 21 CFR 56.115(a)(2) | Minutes of IRB meetings |
| 7319 | 21 CFR 56.115(a)(3) | Records of continuing review |
| 7325 | 21 CFR 56.111(a)(5) | Informed consent documented |
| 7334 | 21 CFR 56.115(a)(5) | List of members |
| 7371 | 21 CFR 56.108(a)(1) | Reporting findings and actions to investigator/institution |
| 7654 | 21 CFR 56.110(b) | Research not eligible for expedited review |