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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 setsThe TIG provides instructions and recommendations to implement these models for the collection, representation, and exchange of tobacco product data. Controlled terminology and formats support implementation of all models. Standards for data exchange are applicable to all use cases and allow for the exchange of metadata for CRFs, tabulation datasets, and analysis datasets. 

The following table describes implementation of CDISC models with supporting standards and TIG sections.

Metadataspec
CasesProduct descriptionNon-clinical Individual Health Impact on Population Health
Use

STANDARDS FOR DATA COLLECTION

STANDARDS FOR DATA TABULATION

STANDARDS FOR DATA ANALYSIS

Case

Standards for Data Collection

Standards for Data Tabulation

Standards for Data Analysis

Product description

Not applicable, as data are not collected via CRFs.

Data:

Controlled Terminology terminology and Formatsformats:

Data Exchangeexchange:

  • CDISC
DEFINE.

Data:

Controlled Terminology terminology and Formatsformats:

Data Exchangeexchange:

  • CDISC
DEFINE.

Nonclinical

Not applicable, as data are not collected via CRFs.

Data:

Controlled Terminology terminology and Formatsformats:

Data Exchangeexchange:

  • CDISC
DEFINE.

Not applicable, as data may be analyzed directly from tabulation datasets.

Product impact on

individual health

Data:

Controlled Terminology terminology and Formatsformats:

Data Exchangeexchange:

Data:

Controlled Terminology terminology and Formatsformats:

Data Exchangeexchange:

  • CDISC
DEFINE.

Data:

Controlled Terminology terminology and Formatsformats:

Data Exchangeexchange:

  • CDISC
DEFINE.

Product

impact on population health

Not applicable, as data input parameters generated for population modeling are calculated via upstream analyses.

Not applicable, as data input parameters generated for population modeling are calculated via upstream analyses.

Data:

Controlled Terminology terminology and Formatsformats:

Data Exchangeexchange:

  • 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

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