How Standards Work Together

An explanation of the General Observation Classes and "Special Purpose domains" might be in order. Maybe the concept map from the SDTM model (PDF page 8) or a modified version of it would be sufficient at this stage of the TIG.

In draft

Standards in this guide are end-to-end implementations of CDISC models designed to ensure the traceability and transparency of data across activities in the data lifecycle. Implementation of models per this guide in relation to activities which support collection, tabulation, analysis, and exchange of data are further described in the table below.

Observations

are imputed for analysis purposes, the imputed dates will be generated in the Analysis Data Model (ADaM) but not in the SDTM submission data sets.

Use Cases (below)	STANDARDS FOR DATA COLLECTION	STANDARDS FOR DATA TABULATION	STANDARDS FOR DATA ANALYSIS
Product description		Data: CDISC SDTM CDISC TIG Standards for Tabulation Controlled Terminology and Formats: How to Use Controlled Terminology and Formats Data Exchange: CDISC DEFINE.XML Standards for Data Exchange	Data: CDISC ADaM CDISC TIG Standards for Analysis Controlled Terminology and Formats: How to Use Controlled Terminology and Formats Data Exchange: CDISC DEFINE.XML Standards for Data Exchange
Non-clinical		Data: CDISC SDTM CDISC TIG Standards for Tabulation Controlled Terminology and Formats: How to Use Controlled Terminology and Formats Data Exchange: CDISC DEFINE.XML Standards for Data Exchange
Product impact on Individual Health	Data: CDISC CDASH Model CDISC TIG Standards for Collection Controlled Terminology and Formats: How to Use Controlled Terminology and Formats Data Exchange: CDISC ODM Standards for Data Exchange	Data: CDISC SDTM CDISC TIG Standards for Tabulation Controlled Terminology and Formats: How to Use Controlled Terminology and Formats Data Exchange: CDISC DEFINE.XML Standards for Data Exchange	Data: CDISC ADaM CDISC TIG Standards for Analysis Controlled Terminology and Formats: How to Use Controlled Terminology and Formats Data Exchange: CDISC DEFINE.XML Standards for Data Exchange
Product Impact on Population Health			Data: CDISC ADaM CDISC TIG Standards for Analysis Controlled Terminology and Formats: How to Use Controlled Terminology and Formats Data Exchange: CDISC DEFINE.XML Standards for Data Exchange

Standards for Collection

Standards for Tabulation

Standards for Analysis

CDISC CDASH Model

In this guide, the CDASH Model is implemented to support development of CRFs for the Product Impact on Individual Health use case only. The CDASH Model is the earliest model implemented for this use case.
The CDASH Model defines a basic set of data collection fields that are expected to be present on the majority of CRFs.
The use of CDASH data collection fields and variables facilitates mapping to tabulation datasets implemented from the SDTM.
When data can be collected as it will be represented in a tabulation dataset, with no transformations or derivations, the TIG SDTM variable names are presented in the TIG CDASH to collect the data.
In cases where collected data must be transformed or reformatted prior to inclusion in a tabulation dataset, or where a corresponding SDTMIG variable does not exist, CDASH has created standardized data collection variable names.

CDISC SDTM

The SDTM is implemented for use cases

CDISC ADaM

The ADaM is described for general usage as well as being implemented for use cases
Several of the use cases describe dataset classes not yet defined in the ADaM

Standards for Data Exchange

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