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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 with unknown or imprecise dates/times 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

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


CDISC TIG provides recommendations (and rules) to implement these various models for representation, and exchange of tobacco product data:

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

CDISC Terminology – Applicable to all use cases and CDISC standards for data collection, data tabulation, data analysis

CDISC Standards for Data Exchange - Applicable to all use cases and for all standards for TIG. Metadata available in the CDISC Library and eCRF portal













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