ICSR Field Reference

Study Registration Number

SectionC.5 Study Identification

Data TypeAN

RequiredNo

Data Last UpdatedMay 12, 2026

1.Field Definition

Element Number	C.5.1.R.1
Element Name	Study Registration Number
English Name	Study Registration Number (Study Registration Number)
Data Type	Alphanumeric
Max Length	50
Required	No
Allowed Values	Free Text nullFlavor: ASKU,NASK

Allowed Null Flavors

ASKUAsked but Unknown - 질문했으나 알 수 없음

NASKNot Asked - 질문하지 않음

2.User Guidance

This data element is used to enter the study registration number assigned in the reporting region (e.g. the EudraCT number for reports from the European Economic Area (EEA)). For details, refer to the regional implementation guides.

3.Validation Rules

Conditional Rules

If (Condition)

N.2.R.3

MFDS-O-CTMFDS-O-CUMFDS-T-CTMFDS-T-CU

Then (Result)

Required

Yes

Not Allowed

NIMSKUNKNAASKUNASKNINFPINF