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To be updated to include all relevant models based on on standards development. |
TIG v1.0 provides specific domain models, assumptions, business rules, and examples for preparing standard data collection, tabulation datasets, and analysis datasets that are based on the CDASH, SDTM, ADaM, and Analysis Results models respectively. This document is intended for companies and individuals involved in the collection, preparation, and analysis of product description, non-clinical, and clinical data that will be submitted to regulatory authorities. The TIG should be used withThis guide describes how to implement CDISC models to standardize collection and representation of tobacco product study data. The CDISC models implemented in this guide are:
- Version 1.2 of the CDISC Clinical Data Acquisition Standards Harmonization (CDASH, available at at https://www.cdisc.org/standards/foundational/cdash/cdash-model-v1-2), which provides a general framework for creating fields to collect information on CRFs and includes the model metadata, which shows the standard variables in the model.
- Version 2.0 of the CDISC Study Data Tabulation Model (SDTM, available at https://www.cdisc.org/standards/foundational/sdtm), which describes the general conceptual model for representing clinical
study data that is submitted to regulatory authoritiesprovides a standard model for study data tabulations.Jira showSummary false server Issue Tracker (JIRA) serverId 85506ce4-3cb3-3d91-85ee-f633aaaf4a45 key TOBA-1 - Version 2.1 of the CDISC Analysis Data Model (ADaM, availble at ), which describes...Version TBD of the Analysis Results Model... , available at https://www.cdisc.org/standards/foundational/adam) which specifies the fundamental principles and standards to follow in the creation of analysis datasets and associated metadata
- Version 1.0 Lab-XML (Placeholder - This is not a model. Updates to text pending.)
- Version 2.0 ODM-XML (Placeholder)
- Version 1.0 Lab-XMLVersion 2.1 Define-XML. .. (Placeholder)
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