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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.


CDISC SDTM

  • The SDTM is implemented for use cases
Metadataspec
Standards for CollectionStandards for TabulationStandards 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 ADaM

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













Metadataspec

Standards for CollectionStandards for TabulationStandards 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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