Analysis Data Model (ADaM) specifies the fundamental principles and standards to follow in the creation of analysis datasets and associated metadata. The ADaM Implementation Guide versions 1.0, 1.1, and 1.2 and the ADaM Structure for Occurrence Data (OCCDS) 1.0 include specific guidelines and rules for defining and creating ADaM datasets.
Version 3.0 of the ADaM Conformance Rules comprises a subset of these rules for the purpose of enabling development of software to perform ADaM dataset checks. ADaM Conformance Rules v3.0 includes 1000+ rules that can help to ensure ADaM datasets have been constructed in a manner consistent with the relevant ADaMIG.
These rules are intended to be used for single studies. They are not meant to define the full spectrum of ADaM conformance as they cannot evaluate the content of ADaM datasets vs. external systems to ensure, for example, that all observed and derived rows for a given analysis parameter are included.
A complete assessment of conformance must be based on an understanding of the scope of the study data and the analyses the datasets support in addition to the published conformance rules and the general rules and principles outlined in the ADaMIG.
Public Review Comments
CDISC posts Public Review comments and resolutions to ensure transparency and show implementers how comments were addressed in the standard development process.