12 Study Type (C.5.4.KR.1) for studies other than Clinical Trial or Compassionate Use studies
It is mandatory to transmit OTHERSTUDIESTYPE [C.5.4.KR.1] when C.5.4 = 3 Other Studies.
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 |