# Leveraging CDISC innovative approaches and emerging technology to expedite development of open, end-to-end tobacco standards to facilitate regulatory submission, review and decision making.

> **NIH FDA U24** · CLINICAL DATA INTERCHANGE STAND/CONSORT · 2022 · $230,834

## Abstract

Project Summary – CDISC Tobacco Standards Project
CDISC is well positioned to assist FDA-CTP in achieving all four overarching program strategic
goals and program objectives listed in RFA-FD-22-022. CDISC, for over 20 years, has supported
open, consensus based, standards development and has maintained and promoted a well-
defined data standards governance function regulated by CDISC COP-001 Standards
Development [7]. All CDISC standards development follow this rigorous process to
ensure quality and fitness for use as well as encourage the wide adoption of the standards.
Leveraging deep previous experience and the standards development process mentioned above,
the CDISC Standards Development Team will engage stakeholders in the
publication of a Tobacco Implementation Guide v1.0, conformance rules and
development and
machine-readable
Biomedical Concepts (BCs) for core tobacco clinical research concepts. Conformance
rules, provide a critical quality check in ensuring study data conform to CDISC standards and BCs
can result in a significant step towards end-to-end automation and traceability. CDISC will ensure
alignment and harmonization with the CDISC Study Data Tabulation Model (SDTM) for FDA
electronic submissions, Clinical Data Standards Harmonization (CDASH), and ADaM. These
standards will be freely available on the CDISC website.
The CDISC Data Science team will update the CDISC Library model and software to load and
generate outputs for BCs, new standards content, ready-to-implement metadata, and executable
representations of conformance rules and represent metadata in ODM and Define-XML and
develop a model to include TAUG/Foundational content into CDISC Library [35] that includes the
ability to generate ready-to-implement metadata and normative standards metadata content.
CDISC will also develop educational content and make it available to implementers and utilize
multiple channels of dissemination/outreach to communicate the release of the Tobacco
Implementation Guide v1.0 and the new Library features to the broader research
community. CDISC also proposes to leverage the FHIR-CDASH mapping to enable CTP to
explore application of Real-World Data (EHR). CDISC’s catalogue of existing standards, along
with the innovative approaches and technology outlined in this application will help to position
FDA-CTP to move toward optimizing activities that advance tobacco research, regulatory
submission, review and decision making and post marketing surveillance of tobacco products.

## Key facts

- **NIH application ID:** 10413694
- **Project number:** 1U24FD007488-01
- **Recipient organization:** CLINICAL DATA INTERCHANGE STAND/CONSORT
- **Principal Investigator:** Sam HUME
- **Activity code:** U24 (R01, R21, SBIR, etc.)
- **Funding institute:** FDA
- **Fiscal year:** 2022
- **Award amount:** $230,834
- **Award type:** 1
- **Project period:** 2021-12-01 → 2023-11-30

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10413694

## Citation

> US National Institutes of Health, RePORTER application 10413694, Leveraging CDISC innovative approaches and emerging technology to expedite development of open, end-to-end tobacco standards to facilitate regulatory submission, review and decision making. (1U24FD007488-01). Retrieved via AI Analytics 2026-05-25 from https://api.ai-analytics.org/grant/nih/10413694. Licensed CC0.

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