1. Monika Kawohl Statistical Programming Accovion GmbH
define.xml Outlook ADaM Metadata Requirements
Monika Kawohl
Statistical Programming
Accovion GmbH

2. ADaM Documentation (Metadata)
Analysis Results Metadata
For key analyses only
Analysis Dataset Metadata
Analysis Variable Metadata including Parameter Value-Level Metadata
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3. Analysis Results Sample
Display
Result 1
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4. Analysis Results Metadata
Permissible although very user/reviewer friendly
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5. ADaM Dataset Metadata column NOT Link to in define.xml, dataset
Link to analysis
variable metadata
=> next slide
column NOT
in define.xml,
contents
sponsor specific
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6. Analysis Variable Metadata including Parameter Value-Level Metadata
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7. Further Documentation
Supplemental Data Definitions
Supplementaldatadefinitions.pdf
Per study, specific data analysis
Textual description
Data dependencies, flow charts
Reviewers‘ Guide
PDF document
Per submission
Submission specifics
High level folder structure, contents
Similarities across studies/analyses
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8. References Analysis Data Model, V2.1 (http://www.cdisc.org/adam)
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9. Thank you! Questions?
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