Standard Analyses 'Deliverables & Key Links'

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  • Video:
    • Study-size adjusted percentages. Why, when & what? Brenda Crowe PhD, Senior Research Advisor, Global Statistical Sciences, Eli Lilly.
    • Script Metadata for Sharing. Why, what and how to describe and access scripts in Github repository using technologies of YML, R, R shiny and R package. Hanming Tu, VP of IT, Frontage laboratories.
  • Published Whitepapers:
    • Screen Shots of the Display created using Scripts contributed by the FDA Version 1.1: 23-May-17 (PDF Version,Word Version)
    • Adverse Events White Paper Version 1.0: 03FEB2017 (PDF version,Word version)
    • Analyses and Displays Associated with Measures of Central Tendency - Focus on Vital Sign, Electrocardiogram, and Laboratory Analyte Measurements in Phase 2-4 Clinical Trials and Integrated Submission Documents 10Oct2013 (PDF Version, Word version)
    • Analyses and Displays of PK 25Mar2014
    • Analyses & Displays Associated with Demographics, Disposition, & Medications in Phase 2-4 Clinical Trials & Integrated Summary Documents (Version 2.0: 02-Mar-18: Doc ID: WP003: PDF, Word)
    • Analyses and Displays Associated with Outliers or Shifts from Normal to Abnormal: Focus on Vital Signs, Electrocardiogram, and Laboratory Analyte Measurements in Phase 2-4 Clinical Trials and Integrated Summary Documents 10Sep2015 (PDF Version, Word version)
    • Analyses and Displays Associated with Thorough QT/QTc Studies 11Mar2016 ('PDF' Version,Word version)
  • Archived publication
    • Analyses and Displays Associated with Demographics, Disposition, and Medications in Phase 2-4 Clinnical Trials and Integrated Summary Documents 07Oct2014 (PDF Version, Word version)
  • Script Repository: