# An eSubmission pilot with stakeholder education to ensure successful adoption of data standards by regulators, industry, and global organizations for tobacco research, regulatory review, data sharing.

> **NIH FDA U24** · CLINICAL DATA INTERCHANGE STAND/CONSORT · 2024 · $249,922

## Abstract

7. Project Summary/Abstract
This proposed project is a continuation of the collaboration between CDISC and CTP formed to
develop the Tobacco Implementation Guide (TIG) v1. In response to RFA-FD-24-001, this project
will build on prior work done with CTP and directly address overarching project goals and
objectives leveraging innovative tools and technologies. These innovative tools and technologies
include the development of Biomedical Concepts (BCs), CDISC Library, the Operational Data
Model (ODM), Analysis Results Standard (ARS) and CDISC Open Rules Engine (CORE). CDISC
is well positioned support the CTP in achieving the overarching goals of supporting open,
consensus-based, data standards development, promoting eSubmission of regulatory data using
established standards and facilitating CTPs review process to leverage data conformed to
standards. Leveraging previous experience and a well-established governance and open
consensus-based standards development process CDISC will engage stakeholders to achieve
the following aims:
Aim 1: Initiation of stakeholder adoption and further refinement of Tobacco Implementation Guide
v1.0 CDISC standards for submissions to CTP through an electronic submission (e-Submission)
pilot.
Aim 2: Development of a documented framework for long-term collaboration, support, and
refinements to Tobacco Implementation Guide v1.0 standards for subsequent e-Submissions and
other data standardization needs.
Aim 3: Provision and creation of educational content to promote support understanding of the
value of data standards in research and to support consistent implementation of TIG v1.0
standards for submissions to CTP.

## Key facts

- **NIH application ID:** 10999310
- **Project number:** 1U24FD008201-01
- **Recipient organization:** CLINICAL DATA INTERCHANGE STAND/CONSORT
- **Principal Investigator:** Christine Connolly
- **Activity code:** U24 (R01, R21, SBIR, etc.)
- **Funding institute:** FDA
- **Fiscal year:** 2024
- **Award amount:** $249,922
- **Award type:** 1
- **Project period:** 2024-06-01 → 2026-05-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10999310

## Citation

> US National Institutes of Health, RePORTER application 10999310, An eSubmission pilot with stakeholder education to ensure successful adoption of data standards by regulators, industry, and global organizations for tobacco research, regulatory review, data sharing. (1U24FD008201-01). Retrieved via AI Analytics 2026-05-24 from https://api.ai-analytics.org/grant/nih/10999310. Licensed CC0.

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