Purpose

The Tobacco Implementation Guide (TIG) Version 1.0 has been prepared by the Tobacco Implementation Guide team of the Clinical Data Interchange Standards Consortium (CDISC). This implementation guide is intended to guide the organization, structure, and format of standard data collection, data tabulation, and data analysis for tobacco product research submitted to a regulatory authority

TIG Version 1.0 provides specific domain models, assumptions, business rules, and examples for preparing standard data collection, tabulation datasets, and analysis datasets that are based on the CDASH, SDTM, ADaM, and Analysis Results models respectively. This document is intended for companies and individuals involved in the collection, preparation, and analysis of product description, non-clinical, and clinical data that will be submitted to regulatory authorities. The TIG should be used in close concert with:

• Version 1.2 of the CDISC Clinical Data Acquisition Standards Harmonization (CDASH, available at https://www.cdisc.org/standards/foundational/cdash/cdash-model-v1-2), provides a general framework for creating fields to collect information on CRFs and includes the model metadata, which shows the standard variables in the model.
• Version 2.0 of the CDISC Study Data Tabulation Model (SDTM, available at https://www.cdisc.org/standards/foundational/sdtm), which describes the general conceptual model for representing clinical study data that is submitted to regulatory authorities.
• Version 2.1 of the CDISC Analysis Data Model (ADaM, avalible at ), which describes...
• Version TBD of the Analysis Results Model... 
• Version 2.0 ODM-XML
• Version 1.0 Lab-XML
• Version 2.1 Define-XML...

The Therapeutic Area Data Standards Modules for Type 1 Diabetes - Screening, Staging, and Monitoring for Preclinical Type 1 Diabetes were developed with support from The Leona M. and Harry B. Helmsley Charitable Trust using the CDISC standards development process. This process included collecting input from various stakeholders to ensure the standard is as thorough as possible. A number of volunteers and experts provided resources and input to support the development of this standard. The goal of this initiative is to identify a core set of clinical therapeutic area concepts and endpoints for targeted therapeutic areas and translate them into CDISC standards to improve semantic understanding, support data sharing, and facilitate global regulatory submission. As with all CDISC therapeutic area standards, the purpose of this standard is to describe how to use CDISC standards to represent data pertaining to a targeted therapeutic area—in this case, screening, staging, and monitoring for preclinical type 1 diabetes (T1D). "Preclinical" refers to the time before stage 3 (clinical diagnosis) of T1D.

This first provisional version (v1.0 Provisional) of the standard focuses on T1D clinical trials involving screening, staging, and monitoring for preclinical T1D.

This document provides advice and examples for Clinical Data Acquisition Standards Harmonization (CDASH) and the Study Data Tabulation Model (SDTM), including

• guidance on the use of domains and variables;

• sample annotated case report forms (aCRFs); and

• examples of SDTM datasets, with text describing the situational context and pointing out records of note.

The biomedical concepts covered in this guide were selected from concepts identified by one or more stakeholders as important, and which were not addressed or were not completely addressed by existing CDISC implementation guides. This user guide does not provide guidance on what data are needed for regulatory submission or approval; it only provides advice on how to represent data in a standard form.