This Public Review is intended to solicit feedback on the draft SDTM v1.8. SDTM v1.8 serves as the model for the SENDIG-Animal Rule v1.0 and is intended to be used in conjunction with the SENDIG v3.1 for data being submitted to the US Food & Drug Administration (FDA) under the Animal Rule.
CDISC relies on your input to ensure neutral, consensus-based data standards are developed and adopted by a diverse global community interested in improving research processes and quality for the benefit of all.
View the draft: Study Data Tabulation Model v1.8.
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