12 Study Type (C.5.4.KR.1) for studies other than Clinical Trial or Compassionate Use studies
For studies other than Clinical Trial or Compassionate Use, Study Type C.5.4 = 3 Other studies (e.g., pharmacoepidemiology, pharmacoeconomics, intensive monitoring, post marketed surveillance), it is mandatory to transmit C.5.4.KR.1 Other Studies Type.
| Element ID | Element Description | Allowed Values |
|---|---|---|
| C.5.4.KR.1 | Other Studies Type | 1 = Investigation into usage when reporting for a review
2 = Post-marketing clinical study when reporting for a review 3 = Special investigation when reporting for a review 4 = Other |
To achieve this, Oracle Argus Safety Flexible code list is enhanced with additional values in Console > Code Lists > Flexible re-categorization > CASE_CLASSIFICATION:
- The new MFDS attribute is added.
- The existing E2B(R3) attribute is updated for the additional values.
It is recommended to set the Console > Business configuration > Studies > Observe Study Type according to the Other Study Type so that C.5.4 will be transmitted as 3 (Other studies) and C.5.4.KR.1 will be transmitted as corresponding MFDS attribute value.
What this means to business users: No additional data entry required (and derived from configuration)
| CODE | En | E2B | Ja | MFDS |
|---|---|---|---|---|
| 1 | Clinical Trial | 1 |  |
- |
| 2 | Individual Patient Use | 2 |  |
- |
| 3 | Other Studies | 3 |  |
4 |
| 4 | CIRM Case | - |  |
- |
| 5 | SAW not applicable to device | - |  |
- |
| 6 | SAE not applicable to drug | - |  |
- |
| 7 | Combination Product | - |  |
- |
| 8 | Investigation into usage | 3 |  |
1 |
| 9 | Post-marketing clinical study | 3 |  |
2 |
| 10 | Special investigation | 3 |  |
3 |