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ADaM define.xml - Metadata Design

ADaM define.xml - Metadata Design. Analysis Results Metadata List of key analyses (as defined in change order) Analysis Results Metadata per key analyses Reference: CDISC SDTM/ADaM Pilot Dataset Metadata Variable Metadata Value Level Metadata Controlled Terminology

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ADaM define.xml - Metadata Design

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  1. ADaM define.xml - Metadata Design • Analysis Results Metadata • List of key analyses (as defined in change order) • Analysis Results Metadata per key analyses • Reference: CDISC SDTM/ADaM Pilot • Dataset Metadata • Variable Metadata • Value Level Metadata • Controlled Terminology • External document link to SDTM define.xml • Supplemental data definitions • Analysis datasets creation programs, analysis programs + outputs for key analyses/datasets all provided and hyperlinked

  2. Link to Analysis Metadata (s.b.) Link to Output in PDF format, ideally implemented via named destination in CSR Link to Variable Metadata of Dataset Link to analysis program in addition to SAP Analysis Results Metadata Sample

  3. SDTM - Dataset Metadata

  4. ADaM Dataset Metadata • Dataset • Description • Class (not included in ADaM) • Structure • Purpose • Keys • Location • Documentation • Reference to dataset creation program

  5. SDTM - Variable Metadata

  6. ADaM - Variable Metadata • Variable • Label • Type • Length/Format • Controlled Terminology • Role (not included in ADaM) • Source/Computational Method instead of Origin and Comment • Separate Computational Method Section N/Y? • Derivation may be described via pseudo code in Source column • Additional Comment N/Y?

  7. SDTM - Variable Value Level Metadata

  8. ADaM - Variable Value Metadata • Source Dataset and Variable • Variable Value • Label • Type • Length/Format • Controlled Terminology • Role (not included in ADaM) • Source/Computational Method instead of Origin and Comment • Separate Computational Method Section N/Y? • Derivation may be described via pseudo code in Source column • Reference of SDTM or ADaM variables (<domain>.<var>) • Additional Comment N/Y?

  9. SDTM/ADaM Computational Algorithms • Complex Derivations • Derivations Used More than Once

  10. SDTM - Controlled Terminology/Code Lists • External dictionary references incl. versions • e.g., MEDDRA, WHODRUG

  11. ADaM - Controlled Terminology • As in SDTM define.xml • Separation (?) between • Discrete Value Lists • Code Lists • Emphasis on -N Variables • Numeric codes for sorting

  12. ADaM Supplemental Data Definitions • PDF Document • Metadata not suitable for tabular presentation • Process dependencies • General study specifics • Details on programs • General (format, focus on key analyses) • Import of SAS datasets • Programming environment programs • Analysis datasets creation programs • Analysis results creation programs • Location of analysis results / outputs

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