FDA Regulatory Submissions, Define.xml and Clinical Data Management | Clinical Cert Ep 6
SAS Users Asia Pacific
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FDA Regulatory Submissions, Define.xml and Clinical Data Management | Clinical Cert Ep 6
22 просмотра · 11 дней назад
SAS Users Asia Pacific
203 подписчика
22 просмотра · 11 дней назад
Regulatory compliance is a critical skill for clinical programmers. This session presented by Ume Nishar Banu, Technical Training Consultant at SAS specializing in Clinical SAS Programming, covers FDA submission requirements, XPT transport files, variable constraints, Define.xml metadata, controlled terminology, and traceability expectations. Learn how clinical datasets are prepared and documented for regulatory reviewers.
#DefineXML #FDA #RegulatorySubmission #ClinicalTrials #DataStandards #CDISC #ClinicalProgramming #ClinicalSAS
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