An Analysis Data Model Implementation Guide (ADaMIG) is developed in reference to a specific ADaM model. Currently, all ADaMIGs are supported by the ADaM v2.1 model. Additional ADaM supplements containing normative content for specific analysis use-cases have also been developed. For example, the ADaM Occurrence Data Structure (OCCDS) v1.0 was developed to describe the general data structure and content typically found in occurrence analysis. While these ADaM supplements are developed in relation to an ADaMIG, it may be appropriate to use them with an ADaMIG published at a later date. For example, the ADaM OCCDS v1.0 was developed in reference to ADaMIG v1.1; however, it is also applicable to ADaMIG v1.2. For a comprehensive overview of which ADaM documents can be used together, please reference ADaMIG v1.2 Table 18.104.22.168 “Other CDISC Documents and Their Applicability to ADaMIG Versions.”
In addition to models and implementation guides, conformance rules have been developed, which help to ensure that generated data structures conform to the standards. These rules aim to identify all conformance rules and case logic from ADaM documents, classifying and codifying them in a form that supports quality processes and tool development.
ADaM standards are developed to align with analysis needs, enable analysis-ready datasets, and support the needs of reviewers, including traceability back to SDTM.
Study analysis reporting should not need to change in order to be represented in ADaM. Reviewer needs should also be met using ADaM standards.
- Enables the standards to be broadly adopted
- Allows reproduction of analysis results
- Allows re-use of programs and automation of metadata-driven processes
ADaM develops clear, consistent, and predictable analysis dataset standards that can be clearly understood and readily implemented.
Consistency and predictability in the data standard aid in both development and the review process.
- Eases implementation of the ADaM standard
- Fosters communication between users of ADaM datasets
Include rules/validation checks as part of development
ADaM sets the standard for both data and metadata.
Clear communication can be achieved by readable metadata.
- Aids in clear and unambiguous communication.
- Allows for representation in CDISC Library
ADaM standards are developed with the expectation of SDTM data as the source and Define-XML as the standard for delivering metadata.
SDTM, ADaM, and Define-XML are all parts of the CDISC standard.
- Enables standards to work together.
- Supports traceability across the CDISC standards
ADaM deliverables are determined and prioritized based on a blend of considerations, including addressing the most commonly occurring analysis needs, regulatory guidance, other CDISC initiatives and developments, and team members’ interest.
Deliver what industry needs and we have the skill set to create.
Provides solutions that are broadly applicable, taking advantage of interest.