April 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

April Analysis Results Metadata Sample 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 Link to Analysis Metadata (s.b.)

April SDTM - Dataset Metadata

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

April SDTM - Variable Metadata

April 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?

April SDTM - Variable Value Level Metadata

April 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 (. ) Additional Comment N/Y?

April SDTM/ADaM Computational Algorithms Complex Derivations Derivations Used More than Once

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

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

April 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