ADaM defines dataset and metadata standards that support:
ADaM is one of the required standards for data submission to FDA (U.S.) and PMDA (Japan).
Details on the requirements for FDA are specified in the FDA’s Data Standards Catalog for NDA, ANDA, and certain BLA submissions. For more information, please visit the FDA Guidance on Standardized Data.
Details on the requirements for PMDA can be found on the Advanced Review with Electronic Data Promotion Group page.
To help the clinical research community implement ADaM, CDISC has posted the ADaMIG v1.1 Release Package, which includes the following documents associated with that release:
To help the clinical research community implement ADaM, CDISC has posted the ADaMIG v1.0 Release Package, which includes the following documents associated with that release:
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.
|ADaM Conformance Rules v2.0||1.07 MB|
|ADaM Conformance Rules v2.0 Public Review Comments||26.03 KB|
ADaMIG v 1.1 updates Version 1.0 with clarifications, corrections, new variables, additional examples, and references to current documents. It is intended to guide the organization, structure, and format of analysis datasets and related metadata. ADaMIG v 1.1 specifies ADaM standard dataset structures and variables, including naming conventions, and presents standard solutions to implementation issues, illustrated with examples. The ADaMIG must be used in close concert with the ADaM document v2.1.
ADaM v2.1 explains the purpose of ADaM and how it can be used to support efficient generation, replication, and review of analysis results. The document describes fundamental principles that apply to all analysis datasets, with the driving principle being that the design of analysis datasets and associated metadata facilitate explicit communication of the content of, input to, and purpose of, submitted analysis datasets. It also describes ADaM metadata, the subject-level analysis dataset (ADSL) and the Basic Data Structure (BDS).
ARM v1.0 for Define-XML v2.0 supports the submission of Analysis Results Metadata (ARM) as defined in ADaM v2.1.