8 Clinical Trial Approval Number (C.5.1.r.1) and Clinical Trial Serial Number (C.5.3) for Study cases
For cases that are Clinical Trial (CT) or Compassionate Use (CU), it is mandatory to transmit the data as outlined in the table below.
| Element ID | Element description | Data to transmit |
|---|---|---|
| C.5.1.r.1 | Study Registration Number | Clinical Trial Approval Number issued by MFDS |
| C.5.3 | Sponsor Study Number | Clinical Trial Serial Number or Clinical Trial Plan Number issued by MFDS |
To achieve this, set up the MFDS specific numbers in Console > Study Configuration > Clinical References section:
- To transmit Clinical Trial Approval Number issued by MFDS in C.5.1.r.1, select Reference Type = CT Approval Number, and enter the Reference Number for Country = Korea, Republic of.
- To transmit Clinical Trial Serial Number issued by MFDS in C.5.3, select Reference Type = CT Serial Number, and enter the Reference Number for Country = Korea, Republic of.
- To transmit Clinical Trial Plan Number issued by MFDS in C.5.3, select Reference Type = CT Plan Number and enter the Reference Number for Country = Korea, Republic of.
