| ◆JAPAN |
| ◆
PROPOSAL-１ |
|
|
| No legal |
|
| framework |
|
|
|
| GCP, |
|
| Medicines Act |
|
| MHLW |
| PMDEC |
| approve |
| Review |
| IRB |
| IRB |
| IRB |
| IRB |
| discrepancy |
| IRB |
| IRB |
| IRB |
| IRB |
| OPSR |
| IRB |
| IRB |
| IRB |
| IRB |
|
|
| Consultation |
|
| inspection |
|
| IRB |
| IRB |
| IRB |
| IRB |
| Industry |
| academia |
| discrepancy |