http://www.cdisc.org/adam - 02/13/16 12:11:33 - 04/06/11 08:34:39
ADaM Implementation Guide (ADaMIG) v1.1. The structure is built on the nomenclature of the Study Data Tabulation Model Implementation Guide (SDTMIG) V3.2 standard for collected data, and has added content required for statistical analyses. OCCDS includes metadata and examples applied to adverse events (which were previously addressed by the ADaM Data Structure for Adverse Event Analysis released on May 10, 2012), as well as concomitant medications, and medical history.
). The aim of this specification is to support the submission of Analysis Results Metadata as defined in the CDISC ADaM Analysis Data Model Version 2.1 document. The release package consists of a zip file that includes a readme file, the specification document, an ADaM based Define-XML example and the Analysis Results Metadata schema. Refer to the readme file for further details.
- Comments due 29 January 2016
Version 1.0 of the ADaM Structure for Occurrence Data (OCCDS) v1.0 is available (
Version 1.0 of the Analysis Results Metadata Specification for Define-XML v2 is available (
) of the ADaM validation checks correspond to the ADaMIG v1.0, ADAE, and BDS-TTE. All changes and updates are described in Appendix A. Some checks have been reworded for clarification. In addition, 75 new checks have been added to cover rules not previously addressed. The additional checks cover the addition of checks for Adverse Events (ADAE) and the ADaM Basic Data Structure for Time-to-Event Analyses.
Version 1.2 of the ADaM validation checks correspond to the ADaMIG, v1.0. All changes and updates are described in Appendix 2. Some checks have been reworded for clarification. In addition, 61 new checks have been added to cover rules not previously addressed.