853108
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- October 24, 2013
- Fiscal Year
- 2014
- Product Type
- Devices
- Project Area
- Bioresearch Monitoring
- Location
- Lafayette, IN (United States)
Additional Details
IRB
Citations
| ID | CFR | Description |
|---|---|---|
| 7278 | 21 CFR 56.107(e) | Conflict of interest |
| 7281 | 21 CFR 56.108(a)(1) | Initial and continuing reviews |
| 7290 | 21 CFR 56.108(c) | Members present for review |
| 7293 | 21 CFR 56.109(f) | Continuing review |
| 7316 | 21 CFR 56.115(a)(4) | Copies of IRB/CI correspondence |
| 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 |
| 7324 | 21 CFR 56.111(a)(4) | Informed consent sought |
| 7339 | 21 CFR 56.108(a)(4) | Changes in approved research |
| 7340 | 21 CFR 56.108(a)(3) | Prompt reporting of changes |
| 7343 | 21 CFR 56.108(b)(3) | Reporting of suspension/termination |
| 7368 | 21 CFR 56.108(a)(2) | More frequent reviews, verification of no changes |
| 7371 | 21 CFR 56.108(a)(1) | Reporting findings and actions to investigator/institution |