The ADaM Implementation Guide, Version 1.0 (ADaMIG v1.0), and the Analysis Data Model, Version 2.1 (ADaM v2.1), have been released by the CDISC Analysis Data Model (ADaM) Team for public review and comment.

Reviewers are asked to submit comments by the close of business on Friday, September 5, 2008.  Final versions are expected to be released by early 2009.

Submitting Comments

Comments should be submitted in the Excel spreadsheet (Comment Template for ADaMIG v1.0 and ADaM v2.1.xls), included in the Review Package, ADaMIG v1.0 and ADaM v2.1 Review Package.zip. 

Please use only this mechanism to provide comments.

About the ADaM Implementation Guide, Version 1.0

The ADaMIG is a new document that is intended to guide the organization, structure, and format of analysis datasets and related metadata.  In addition to the subject-level dataset ADSL, the ADaMIG describes a new multiple-record-per-subject structure:  the ADaM basic data structure.  The majority of analyses, regardless of therapeutic area or type of analysis, can use this standard structure.  Standard metadata and implementation guidance are provided.  The application of the ADaM standard is illustrated in a number of commonly occurring analysis situations.

About the Analysis Data Model, Version 2.1

The ADaM has undergone revisions, most of which were organizational in nature.  Some of the content that was in Version 2.0 of the model has been moved to the new ADaM Implementation Guide, Version 1.0.  Other content has been rearranged, reduced, or clarified.  There have been no changes to the basic principles to be applied to the design of all analysis datasets and the four types of ADaM metadata.

Click here to download ADaM IG v1.0 Draft for Comment and ADaM v2.1 Draft for Comment.

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