From raw data to regulatory submission: A comprehensive SAS workflow for SDTM and ADaM mapping using Define.xml, ADRG, and Csdrg
Keywords:
SDTM, ADaM, SAS Workflow, Define.xml, ADRG, cSDRG, Clinical Data Standards, Regulatory Submissions, CDISC, Data TraceabilityAbstract
The increasing demand for standardized, traceable, and regulator-ready clinical data has led tothe adoption of robust data workflows in the pharmaceutical and clinical research industry
References
Bloom, M., & Edwards, D. (2009). The Submission Data File System: automating the creation of CDISC SDTM and ADaM datasets. Pharmaceutical Programming, 2(1), 41-52. Charalampidou, S., Ampatzoglou, A., Karountzos, E., & Avgeriou, P. (2021). Empirical studies on software traceability: A mapping study. Journal of Software: Evolution and Process, 33(2), e2294.
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Published
2022-04-20
How to Cite
Latha Donapati and Parameswara Reddy Venna. (2022). From raw data to regulatory submission: A comprehensive SAS workflow for SDTM and ADaM mapping using Define.xml, ADRG, and Csdrg . Journal of Computational Analysis and Applications (JoCAAA), 30(2), 649–661. Retrieved from https://eudoxuspress.com/index.php/pub/article/view/3175
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