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Watch-Along Transcript Guide

Use the videos for trainer context and this workshop for deliberate practice. Timestamps refer to the descriptions embedded in the supplied transcript files.

Industry workflow and documents

SDTM-style programming

Use these with Modules 03–04. The workshop uses compact educational mappings; the videos show why specifications and annotation precede programming.

ADaM and outputs

Use these with Modules 05–09. Notice how analysis datasets carry derivations needed by outputs, while reporting programs mostly summarize prepared data.

Validation and submission context

  • Real-Time Projects: 14:24:25 discusses Pinnacle 21 and define.xml.

Use this before Module 10. Pinnacle 21 checks conformance; it does not replace programmer QC, source-to-output traceability, or statistical review. This workshop demonstrates those habits but does not generate a regulatory package.