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Metadataspec
NumConformanceImplementation
1ADaM fundamental principles are followed
  • Datasets and associated metadata clearly and unambiguously communicate the content and source of the datasets supporting the statistical analyses performed in a clinical study.
  • Datasets and associated metadata 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 identify when and how analysis data have been derived or imputed. 
  • Datasets are readily usable with commonly available software tools.
  • Datasets are associated with metadata to facilitate clear and unambiguous communication. Ideally the metadata are machine-readable.
  • Datasets have a structure and content that allow statistical analyses to be performed with minimal programming. Such datasets are described as "analysis-ready." 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.
2ADSL is submittedFor studies that assess the impact of tobacco products on the health of individuals, ADSL and its related metadata are required even if no other analysis datasets are submitted. 
3ADaM datasets follow the normative data found in the TIGDatasets follow the ADaM fundamental principles defined in the ADaM Model document and adheres as closely as possible to the TIG variable naming and other conventions.
4Traceability principles are followedIn the ADaM Model document, it is assumed that the original data sources for ADaM datasets are SDTM datasets, even when ADaM datasets are derived from other ADaM datasets. ADaM has features that enable traceability from analysis results to ADaM datasets and from ADaM datasets to SDTM datasets. These conventions must be followed for ADaM datasets with a CLASS value of BASIC DATA STRUCTURE, OCCURRENCE DATA STRUCTURE, and SUBJECT LEVEL ANALYSIS DATASET. Other analysis datasets should follow this convention where practical and feasible.


Tabulation and analysis dataset conformance can be formally evaluated in relation to defined sets of conformance rules. The CDISC TIG Conformance Rules Version 1.0 is available via the CDISC website, <placeholder, link pending> and includes rules for both tabulation and analysis datasets. Conformance rules for tabulation datasets assess the conformance of dataset structures and contents to the TIG tabulation standards. Conformance rules for analysis datasets assess the conformance of dataset construction to the TIG analysis standards.

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