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Everything about SDTM

Standard for experimental data tabulation

SDTM defines a standard structure for human clinical trial (study) data tabulations and for nonclinical study data tabulations that are to be submitted as part of a product application to a regulatory authority such as the United States Food and Drug Administration (FDA). The Submission Data Standards team of Clinical Data Interchange Standards Consortium (CDISC) defines SDTM. Wikipedia →

đź§­ Start here: a 6-step reading path

  1. Read the overview: SDTMA 5-minute orientation
  2. Skim a recent paper: Evaluating the statistical utility and information loss in the transformation of a real-world oncology database from CDISC-SDTM to OMOP-CDMInfluential work since 2022
  3. Pick up a classic book: Implementing CDISC Using SASThe most-reprinted book on the subject
  4. Read the landmark paper: sDTM: A Supervised Bayesian Deep Topic Model for Text AnalyticsCited 44 times
  5. Go sideways: Clinical Data Interchange Standards ConsortiumA closely related topic
  6. Go sideways: Data definition specificationA closely related topic

đź“– Definitions

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🏆 Landmark papers (most cited)

🆕 Influential since 2022

📚 Books worth reading

Ranked by number of editions on Open Library, a rough measure of how lasting a book is.

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