New Draft Standard Analysis Results Metadata v1.0 for Define-XML v2 -- Now Available for Public Review – Comments due 14 October 2014
The CDISC Draft Analysis Results Metadata (AResM) v1.0 for Define-XML v2 is now available for a 30-day public review. The aim of this new proposed standard is to support the submission of Analysis Results Metadata as defined in the CDISC ADaM standard. The review package consists of a readme file, the specifications document, an ADaM based Define-XML example and the AResM schema. Refer to the readme file for further details.
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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.
The Analysis Data Model Implementation Guide (ADaMIG) is intended to guide the organization, structure, and format of analysis datasets and related metadata. It specifies ADaM standard dataset structures and variables, including naming conventions. It also specifies standard solutions to implementation issues, illustrated with examples. The ADaMIG must be used in close concert with the current version of the Analysis Data Model document.
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.
The additional checks cover these general categories:
- Corollaries to existing checks
- Set of checks for *CAT* variables (e.g. BASECAT, PARCATy)
- Checks for the use of “y” in a variable name for incremental ordering
- Presence and population of PARAM and PARAMCD in BDS datasets
- Need to have a minimum of AVAL or AVALC in BDS datasets
- Comparison of data values between SDTM.DM and ADSL 7) Set of checks for TRT* sequence and grouping variables
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.
The ADaM Examples in Commonly Used Statistical Analysis Methods provides examples of the Analysis Data Model applied in statistical methods that are commonly used. The ADaM subject-level analysis dataset (ADSL) and Basic Data Structure (BDS) and the associated metadata are illustrated. Issues and points to consider when building ADaM datasets and metadata are highlighted.