m MinJi
on

 

Hi, I have a question about 'REGID' TSVCDREF.

EudraCT number has been replaced by EU CT numbers since Feb 2023.

But, "Values for TSVAL when TSPARMCD = "REGID" (Registry Identifier) will be identifiers assigned by the registry (e.g., ClinicalTrials.gov, EudraCT)." is in SDTM IG V3.4.

If study started after Feb 2023 and has an EU CT number, what value will be described in TSVCDREF? EudraCT (depending on SDTM IG example) or EU CT (replaced value) ?

 

Thank you in advance.

Forums: SDTM

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