ADaM Conformance Rules v5.0

Published Date:

The Analysis Data Model (ADaM) specifies the fundamental principles and standards to follow in creating analysis datasets and associated metadata. ADaMIG versions 1.0, 1.1, 1.2, and 1.3; ADaM Structure for Occurrence Data (OCCDS) Implementation Guide v1.0 and v1.1; the ADaMIG for Medical Devices v1.0, ADaMIG for Non-compartmental Analysis (ADNCA) v1.0, and Basic Data Structure for ADaM PopPK Implementation Guide v1.0 all include specific guidelines and rules for defining and creating ADaM datasets.

Version 5.0 of the ADaM Conformance Rules includes 1000+ rules that can help to ensure ADaM datasets have been constructed in a manner consistent with the relevant ADaMIG. ADaM Conformance Rules v5.0 also enables development of software to perform ADaM dataset checks.

ADaM Conformance Rules v5.0 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 that the datasets support, in addition to the published Conformance Rules and the general rules and principles outlined in the relevant ADaMIG.