An ADaM dataset is a particular type of analysis dataset that either:
1. is compliant with one of the ADaM defined structures and follows the ADaM fundamental principles, OR
2. follows the ADaM fundamental principles defined in the ADaM Model document and adheres as closely as possible to the ADaMIG variable naming and other conventions.
The Analysis Dataset Structure
NSERT Figure 1.6.1 Categories of Analysis Datasets
Fundamental Principles
- ADaM datasets must adhere to certain fundamental principles as described in the ADaM Model document:
• ADaM datasets and associated metadata must clearly and unambiguously communicate the content and source of the datasets supporting the statistical analyses performed in a clinical study.
• ADaM datasets and associated metadata must provide traceability to show the source or derivation of a value or a variable (i.e., the data's lineage or relationship between a value and its predecessor(s)). The metadata must identify when and how analysis data have been derived or imputed.
• ADaM datasets must be readily usable with commonly available software tools.
• ADaM datasets must be associated with metadata to facilitate clear and unambiguous communication. Ideally the metadata are machine-readable.
• ADaM datasets should have a structure and content that allow statistical analyses to be performed with minimal programming. Such datasets are described as "analysis-ready." ADaM datasets contain the data needed for the review and re-creation of specific statistical analyses. It is not necessary to collate data into analysis-ready datasets solely to support data listings or other non-analytical displays.
Traceability
Overview
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