Using the Latest terminology version is the best practice?

j John

on April 3, 2024

Hi, I am creating domains based on SDTMIG v3.3. Since Hepatitis C Virus Antibody (HCAB) has been removed from MBTEST (MBTESTCD) in the latest CT (version date 2023-12-15), with the reason for its removal being that in SDTMIG v3.4, antibody tests will be represented by the IS domain, this leads to a CT2002 issue during validation. Consequently, I would like to ask for advice on whether I should use the latest version of CT for validation and document this issue to the reviewer's guide, or use the previous version, which is more suitable for SDTMIG v3.3?

Kind regards,

John

Forums: SDTM

m MinJi

on April 3, 2024

Please use the latest version.

Hi John,

Please refer to the below: Section 6.1.2 "Use of Controlled Terminologies" of FDA study data TCG latest version (Mar 2024)

Sponsors should use the most recent version of the dictionary available at the start of a clinical or nonclinical study.

If a new version becomes available after the start of the study, sponsors may use the most current version of the dictionary for that clinical or nonclinical study.

Also, as you mentioned, you can describe related validation warning (CT2002).

However, if the study is intended to be an integrated analysis, the old version may be used for the consistency of the product.

Best regards,

MinJi