Versions Compared

Key

  • This line was added.
  • This line was removed.
  • Formatting was changed.

...

  • Standards for Collection implement the CDASH Model to support development and use of case report forms (CRFs).
  • Standards for Tabulation implement the SDTM to organize data collected, assigned, or derived in datasets.
  • Standards for Analysis implement the ADaM to specify the principles to follow in the creation of analysis datasets and associated metadata.
  • Standards for Data Exchange and associated resources support the sharing of study data and metadatastructured data between parties and across different information systems.

Standards for tobacco study use cases and by activities are shown below.

Metadataspec
Use caseStandards for CollectionTabulatuonStandards for TabulationStandards for AnalysisStandards for Data Exchange
Product Description 
SDTMADaMDefine-XML
Nonclinical
SDTM
Define-XML
Product Impact on Individual HealthCDASH Model SDTMADaMODM-XML, Define-XML
Product Impact on Population Health

ADaMDefine-XML

...