8 Clinical Trial Approval Number (C.5.1.r.1) and Clinical Trial Serial Number (C.5.3) 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, 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