ADaM Conformance Rules 2.0

Published Date:

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 and 1.1, and the ADaM Structure for Occurrence Data include specific guidelines and rules for defining and creating ADaM datasets. A subset of these rules has been provided as version 2.0 of the ADaM Conformance Rules for the purpose of enabling development of software to perform ADaM dataset checks.

These rules are intended to be used for single studies. They are not meant to define the full spectrum of ADaM compliance 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. The 350+ rules included in this publication can help to ensure that the ADaM datasets have been constructed in a manner that is consistent with the relevant ADaMIG.

A complete assessment of compliance 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.