| Guowei Zhao, Hong Qi |
In clinical studies, applying data cutoff in SDTM (Study Data Tabulation Model) data is crucial for supporting analysis and reporting activities, and subsequent regulatory submissions. Typically, a single data cutoff date is assigned to each study milestone, and the data collected up to that cutoff is utilized for analysis. However, certain trials pose a unique challenge where distinct cohorts have different cutoff dates. It is ideal to apply specific data cutoffs to each corresponding cohort to optimize data analysis while maintaining adherence to industry standards. This paper explores the importance of applying variable data cutoff dates for different cohorts associated with a single milestone in a clinical trial. It addresses the challenges posed by this situation and examines the potential impact on data analysis and interpretation. Furthermore, the paper proposes an effective solution that addresses these challenges while optimizing data analysis and streamlining the submission process. |