Page History

Models Implemented in this Guide 

The TIG guides implementation of CDISC models to standardize collection and , representation, and exchange of exchange of tobacco product study data. The CDISC models implemented in this guide areinclude:

• CDASH Model Version 1.2, which provides a general framework for creating fields to collect information on CRFs
• SDTM Version 2.1, which provides a standard model for study data tabulations
• ADaM Version 2.1, which specifies the principles and standards to follow in the creation of analysis datasets and associated metadata

CDISC foundational standards are available at https://www.cdisc.org/standards.

The TIG also references additional standards and resources to support implementation:

• .2 of the CDISC Clinical Data Acquisition Standards Harmonization (CDASH, available at CDISC Controlled Terminology (available at https://www.cdisc.org/standards/foundationalterminology/cdash/cdash-model-v1-2), which provides a general framework for creating fields to collect information on Case Report Forms (CRFs).Version 2.0 of the CDISC Study Data Tabulation Model (SDTM, controlled-terminology) provides consistent semantics for use across standards.
• The CDISC Non-standard Variables Registry (available at https://www.cdisc.org/standards/foundational/sdtm), which provides a standard model for study data tabulations.terminology/non-standard-variables) serves as a reference for using or creating NSVs, to drive consistency in implementing CDISC Standards.
• CDISC QRS supplements (Version 2.1 of the CDISC Analysis Data Model (ADaM, available at https://www.cdisc.org/standards/foundational/adam) which specifies the principles and standards to follow in the creation of analysis datasets and associated metadata.

Additional Standards and Resources

The following standards and resources are referenced in this guide to further support implementation:

CDISC Controlled Terminology===

Support for Data Exchange

This guide also references the following CDISC tools and standards to support data exchange:

• qrs) provide information on how to structure data in a standard format for public-domain and copyright-approved instruments.
• TIG Conformance Rules Version 1.0 (available at <placeholder, link pending>)

  Jira
  showSummary false server Issue Tracker (JIRA) serverId 85506ce4-3cb3-3d91-85ee-f633aaaf4a45 key TOBA-789

  support the assessment of tabulation and analysis datasets' conformance to TIG standards.
• The CDISC eCRF Portal (available at https://www.cdisc.org/kb/ecrf) provides a platform from which to download standard CRFs, including metadata standardized per the Operational Data Model (ODM
• eCRF Portal
• Version 2.0 of the CDISC Operational Data Model (ODM-XML, available at https://www.cdisc.org/standards/data-exchange/odm), which provides . ODM is a vendor-neutral, platform-independent format for representing and exchanging CRF content in electronic data capture (EDC) tools.
• The CDISC Library (https://www.cdisc.org/cdisc-library) provides access to information regarding new relationships between standards as well as a number of versioned CDISC standards and controlled terminology packages.
• Version 2.1 of the CDISC Define-XML (Define-XML, Version 2.1 (available at https://www.cdisc.org/standards/data-exchange/define-xml/define-xml-v2-1) , which provides a metadata standard used to describe any tabular dataset structure.
• Education curriculum (available at <placeholder, link pending>)

  Jira
  showSummary false server Issue Tracker (JIRA) serverId 85506ce4-3cb3-3d91-85ee-f633aaaf4a45 key TOBA-790

   to support understanding and use of the TIG v1.

Conformance Rules

• 0.

The TIG is a stand-alone implementation guide and is not intended to be inherently related to or dependent on other implementation guides published by CDISC. However, to support alignment across implementation approaches and for efficiency, the TIG was developed in part by leveraging content published in other CDISC implementation guides. Given this, implementers familiar with CDISC documents may recognize alignment and content shared between the TIG and the following guides:

• Version 3.1.1 of the Standard for Exchange of Nonclinical Data Implementation Guide: Nonclinical Studies (SENDIG; available at https://www.cdisc.org/standards/foundational/send/). SEND guides the organization, structure, and format of standard nonclinical tabulation datasets for interchange between organizations such as applicants and contract research organizations (CROs), and for submission to regulatory authorities.
• Version 2.2 of the CDASH Implementation Guide (CDASHIG; available at https://www.cdisc.org/standards/foundational/cdash/). The CDASHIG defines basic standards for the collection of clinical trial data and describes how to implement the CDASH model for specific CRFs.
• Version 3.4 of the SDTM Implementation Guide: Human Clinical Trials (SDTMIG; available at https://www.cdisc.org/standards/foundational/sdtmig/). The SDTMIG is intended to guide the organization, structure, and format of standard clinical trial tabulation datasets used for various purposes, including publication, warehousing, meta-analyses, and regulatory submission.
• Version 1.3 of the of the ADaM Implementation Guide (ADaMIG; available at https://www.cdisc.org/standards/foundational/adam/). The ADaMIG specifies ADaM standard dataset structures and variables, including naming conventions. 

...