2025 Volume 29 Pages 1-8
Background CDISC Controlled Terminology (CT) is used to provide standardized data for regulatory submissions. Updates to controlled terminology can impact the design of electronic case report forms (eCRFs) and the integration of data across multiple studies. However, the implications of these updates have not been thoroughly investigated.
Objective To investigate the details and reasons for changes in Controlled terminology for nine cell surface markers used in the diagnostic criteria for acute lymphoblastic leukemia (ALL) by the Hematology-Oncology Subcommittee of the Japan Children’s Cancer Group (JCCG) and to evaluate their impact on data standardization.
Methods Controlled terminology versions released between 2007 and 2024 were analyzed using R. Updates to Submission Values, definitions, and codes for controlled terminology representing nine cell surface markers were examined.
Results Between 2008 and 2023, terminology related to eight markers was added. Cases were identified where the submission value remained unchanged and continued to be used despite updates to definitions and codes. Additionally, some terms with identical submission values, definitions, and codes existed across multiple codelists. When these terms were removed from codelists, new operational procedures were required.
Conclusions This study clarified the practical implications of controlled terminology updates on data operations and highlighted considerations for integrated analyses. Understanding submission values and their definitions is crucial for maintaining consistency in regulatory submissions and integrated analyses.
