http://www.cdisc.org/adam - Jul 27, 2014 6:51:03 PM - Apr 6, 2011 8:34:39 AM
Analysis Data Model (ADaM)
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This document explains the purpose of the Analysis Data Model (ADaM) and 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. The model document also describes ADaM metadata, the subject-level dataset ADSL, and a multiple-record-per-subject data structure: the ADaM Basic Data Structure (BDS). The Analysis Data Model supports efficient generation, replication, and review of analysis results.
Version 1.2 of the ADaM validation checks correspond to the ADaMIG, v1.0. All changes and updates are described in Appendix 2.
Version 1.0 of the ADaM Basic Data Structure for Time-to-Event (TTE) Analyses provides definitions and examples of the datasets, variables, and metadata that support general TTE analyses. The three scenarios covered by the document are 1) A Single Endpoint with a Binary Value for Censoring, 2) A Single Endpoint with Multiple Values for Censoring, and 3) Composite Endpoints. There are descriptions of typical analyses that are performed in a Time-to-Event Analysis, including example outputs and associated Results-Level metadata. The document also provides clear step-by-step information about how to create and populate the supportive and analyzed datasets and variables required for Time-to-Event Analysis and full traceability.
Version 1.0 of the Adverse Event Analysis Document (ADAE) is based on the CDISC Analysis Data Model: Version 2.1 and Implementation Guide v1.0 documents. The AE structure presented in this document is built on the nomenclature of the Study Data Tabulation Model Implementation Guide (SDTMIG) V3.1.2 standard for collected data, and has added attributes, variables, and data structures required for statistical analyses. The document presents metadata defined for the ADAE dataset. There are also several example display layouts and examples of the data and associated metadata that support the examples.
Standards In Production Content:
Standards In Development Content:
SDTM/ADaM Pilot Project
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