7 Clinical Trial Approval Number and Clinical Trial Serial Number for Study cases
For Study cases where Study Type is Clinical Trial study (C.5.4 OBSERVESTUDYTYPE = 1 Clinical trials) or Study Type is Compassionate Use study (C.5.4 OBSERVESTUDYTYPE = 2 Individual patient use), 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 issued by MFDS |
To achieve this, it is recommended to setup the MFDS specific numbers in Console > Study Configuration > Clinical References section.
- For transmitting 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
- For transmitting 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