Introduction of CJUG SEND Check Tool for SENDIG v3.1.1

<p>For certain types of safety studies required for new drug application in the U.S., applicants are required to submit standardized study data in compliance with CDISC SEND standards. Although de facto standard validator is available to ensure the quality of SEND data packages, it does not cover all the rules issued via documents from FDA and CDISC (e.g., Study Data Technical Conformance Guide, SEND Implementation Guide, etc.). Thus, it is up to the skill level of the SEND implementer to fully understand the above rules and ensure the quality of the SEND data. To address the issues, the CJUG SEND team has released a check tool to ensure the data quality in compliant with SENDIG v3.0 and v3.1 based on the check items lists covered the above documents and rules. FDA issued the requirement to submit SEND datasets in compliance with SENDIG v3.1.1when submitting reports for certain types of safety studies which start after March 15, 2023 (datasets with SENDIG v3.1 also acceptable until FDA’s support ends). Therefore, we made a new check tool for the SEND data in compliance with the SENDIG v3.1.1. In this presentation, we introduce the overview of this new check tool, in which the existing check items and programs in compliance with the SENDIG v3.1 have been also updated.</p>