ADaM Implementation Guide Version 1.0 V1.0
adam_implementation_guide_v1.0
User Manual:
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Page Count: 81
- Analysis Data Model (ADaM) Implementation Guide
- Introduction
- Fundamentals of the ADaM Standard
- Standard ADaM Variables
- ADSL Variables
- ADaM Basic Data Structure (BDS) Variables
- Subject Identifier Variables for BDS Datasets
- Treatment Variables for BDS Datasets
- Timing Variables for BDS Datasets
- Analysis Parameter Variables for BDS Datasets
- Analysis Descriptor Variables for BDS Datasets
- Indicator Variables for BDS Datasets
- Differences Between SDTM and ADaM Population and Baseline Flags
- Other Variables
- Implementation Issues, Standard Solutions, and Examples
- Examples of Treatment Variables for Common Trial Designs
- Creation of Derived Columns Versus Creation of Derived Rows
- Inclusion of All Observed and Derived Records for a Parameter Versus the Subset of Records Used for Analysis
- Inclusion of Input Data that are not Analyzed but that Support a Derivation in the Analysis Dataset
- Identification of Rows Used for Analysis
- Identification of Population-Specific Analyzed Rows
- Identification of Rows Which Satisfy a Predefined Criterion for Analysis Purposes
- Other Issues to Consider
- Appendices