TIG eSubmission Pilot

In June 2024, the US Food and Drug Administration, Center for Tobacco Products (FDA CTP), industry, and CDISC collaboratively published non-proprietary, consensus-based data standards for tobacco product regulatory submissions. Collectively referred to as the Tobacco Implementation Guide Version 1.0 (TIG v1.0), these standards and terminologies are specifically designed to support tobacco research, scientific review, harm reduction, and information exchange. Developed by a multi-disciplinary team of FDA CTP, tobacco industry, and data standards experts, TIG v1.0 standards have the potential to expedite regulatory review and decision making as well as achieve efficiencies for all stakeholders. Support is needed post-publication to ensure successful adoption of standards by stakeholders within FDA CTP and industry to achieve intended efficiencies. 

 

Participation Requirements:

  • Industry members must actively adopt TIG v1.0 standards within their organizations during the project.
  • CTP and industry team members must complete the TIG online education curriculum at the project’s start.

Project Structure:

The project team, operating as a full team and through two workstreams, will meet monthly to review strategy, progress, and findings, with additional weekly workstream meetings (up to one hour, plus two hours of prep).

Workstreams:

  1. Education Workstream: Open to all adopters to strengthen CTP and industry knowledge and adoption of TIG v1.0 through focused educational content.
  2. Simulated eSubmission Workstream: Up to nine applicant organizations will apply TIG v1.0 standards in project-specific eSubmissions to CTP.

When submitting Volunteer Form, select "TIG V1.0 eSubmission Pilot" as the CDISC Standards Development team.

Contact Us

To join our mailing list and receive communications on the TIG eSubmission Pilot and/or indicate your interest to participate, use the form below to submit your contact information, questions, and/or feedback.

Tobacco industry experts are invited to participate as part of a multi-disciplinary team with membership from CTP, industry, and CDISC.  

TIG eSubmission Pilot Volunteer Form

Tobacco industry experts are invited to participate as part of a multi-disciplinary team with membership from CTP, industry, and CDISC. 
Please indicate your interest by using the form below with questions and/or feedback regarding this initiative.

TIG eSubmission Pilot Interest Form

This project is a continuation of the collaboration formed to develop the TIG v1.0 with the goal to support adoption and stakeholder realization of efficiencies. This project enables standards adoption and efficiencies through hands-on experience and subject matter expert support. The project duration will be two years and CDISC will engage FDA CTP, tobacco industry subject matter experts, and other relevant stakeholders through project duration. This project focuses on the completion of three specific aims:

  1. Initiation of stakeholder adoption and further refinement of TIG v1.0 standards for submissions to FDA CTP via an electronic submission (eSubmission) pilot.
  2. Development of a documented framework for long-term collaboration, support, and refinements to TIG v1.0 standards for subsequent eSubmissions and other data standardization needs. 
  3. Provision and creation of educational content to promote understanding of the value of data standards in research and to support consistent implementation of TIG v1.0 standards for submissions to FDA CTP.

All industry volunteers will participate with the understanding that:

  • Data and supporting information shared as part of this project will not be used by FDA CTP for regulatory purposes. 
  • Participants will not receive study or product related feedback from FDA CTP for shared data and supporting information. 
  • Participation in this project and related data entry will not have any bearing on current and future regulatory decisions.
  • Data entry and related information shared as part of this project does not constitute a cross referenceable document for future regulatory product submission. 
 
Aim 1: TIG v1.0 eSubmission Pilot

In alignment with Project Aim 1, up to nine industry organizations will submit datasets standardized per the TIG v1.0 with related information as part of a simulated eSubmission to FDA CTP. Pilot preparation will be conducted in project year 1 with pilot execution in year 2. Pilot eSubmission will demonstrate, enable, and support:

  • Industry application of TIG v1.0 standards in the context of an eSubmission to FDA CTP
  • FDA CTP receipt and processing of TIG v1.0 standardized data as part of an eSubmission
  • FDA CTP reviewer understanding of the structure and formatting of TIG v1.0 standardized data in a way that facilitates of product review 
Submission Types and Pilot Data

Submission types and products in scope for pilot eSubmission are data in the format of a: 

  • Premarket Tobacco Product Application for ENDS with associated e-liquid(s)
  • Substantial Equivalence Report for combustible product(s)

Industry team members participating in simulated eSubmission are responsible to submit a minimum reviewable package (MRP) to FDA CTP. The MRP is comprised of both datasets standardized per the TIG v1.0 in SAS V5 Open Transport format and a brief summary of content within and across datasets. Both deidentified actual and dummy data will be accepted and, when providing dummy data, the data must be a reasonable facsimile of actual data and contribute to a reasonable representation of a hypothetical product.

Pilot Preparation

A volunteer-based TIG team will be formed to support, manage, and refine TIG standards over time. This multi-disciplinary team will be comprised of FDA CTP, tobacco industry, and CDISC subject matter experts. This team will act as a support forum for pilot applicants and FDA CTP reviewers and will continue post-pilot for long-term TIG standards direction and development. Starting with team formation, FDA CTP, industry, and CDISC will begin to formally prepare for pilot execution. 

To build industry and FDA CTP reviewer understanding and application of the TIG v1.0 standards, TIG team members will review the TIG v1.0 in the context of adoption within their organizations and complete the CDISC TIG online education curriculum. Prioritization will be given to understanding and application of standards necessary for the generation and review of datasets required for MRP eSubmission. Pilot participant feedback will be addressed through team activities, including developing and delivering educational resources, creating draft standards for use during the pilot, or both. Additionally, up to identify and develop up to ten CTP-specific business rules to be integrated into CORE to further assess whether the MRP meets FDA CTP requirements beyond CDISC standard conformance.

Pilot Execution

Pilot execution will begin in project year two. The TIG team will meet regularly to support pilot activities. As TIG v1.0 standards are used for pilot eSubmission and adopted within organizations, refinements to better support submissions to FDA CTP may be identified. Suggested refinements will be logged, managed, and resolved, as in pilot preparation. As needed, draft standards will be created for pilot use and may include standards for new concepts for which CDISC Biomedical Concepts will be developed. The viability of draft standards will then be assessed as part of piloting and, if agreed to by consensus, will be retained for inclusion in a future version of the TIG to be scoped and developed per the CDISC Standards Development Process post-pilot. Suggested refinements will also be resolved as part of team activities via development and provision of education. Pilot applicants and FDA CTP will check datasets for conformance to TIG v1.0 standards using an instance of the CDISC Open Rules Engine (CORE) to support overall evaluation of conformance rules. FDA CTP and CDISC will collaboratively assess the need for standardized reporting to support regulatory review in year two, and one to two standardized reports may be developed using the CDISC Analysis Results Standard (ARS). Standard reports created using the ARS will enable consistent submissions across applicants and helps to support traceability and reuse of analysis results.

 
Aim 2: Long-term Framework

The project will conclude with collaborative drafting and publication of a white paper to summarize the pilot experience with learnings and recommendations for both future eSubmissions and standards adoption. Additionally, a documented framework will be developed to outline and guide next steps for long-term stakeholder collaboration, support, and enhancements to TIG v1.0 standards for subsequent eSubmissions and other data standardization use cases. The white paper and long-term framework are intended to serve as the foundation for future FDA CTP, CDISC, and/or industry guidance.

CDISC will coordinate development of the white paper and long-term framework. To prepare for development, the following collected and/or developed over the project duration will be summarized (e.g., organized into key learnings and themes) for review and consideration:

  • All team member feedback and resolutions
  • Pilot-specific draft standards developed to support stakeholder adoption, indicative of gaps in current TIG v1.0 standards
  • Conformance rules findings shared as part of pilot execution
  • Education developed to support stakeholder adoption, indicative of community education needs

Inclusion and future steps for integration of machine-readable data dictionaries (i.e., CDISC Define-XML) and CDISC Dataset-JSON formatted datasets as part of eSubmissions will also be explored.

 
Aim 3: Education

Outreach and education to promote understanding of the value of data standards in research and consistent implementation of TIG v1.0 standards for submissions to FDA CTP will be supported throughout the project’s duration. Activities will be designed to address needs at each stage of the project and will begin at the time of project Scoping and continue through project end.Education resources and trainings will be developed and provided by CDISC with the purpose to:

  • Promote community awareness and adoption of TIG v1.0 standards, resources, and project progress
  • Support consistent implementation of TIG v1.0 standards and relevant related standards
  • Enable use of applicable CDISC tools, technology, platforms, and tools by standards implementers

FDA CTP will provide instructions related to Precision FDA and other FDA processes and tools in the context of this pilot.

Community Outreach

Irrespective of project participation, the community as a whole will be offered educational resources to promote awareness and adoption of TIG v1.0 standards, resources, and project progress in the context of submissions to FDA CTP. Current information will be available to the community at any time via a dedicated public page on the CDISC website and a CDISC public TIG-specific LinkedIn channel. Periodic in-person and virtual presentations via conferences, webinars, and/or workshops will be conducted with the opportunity to address community questions in real-time. 

Pilot Preparation

To build industry and FDA CTP reviewer understanding and application of the TIG v1.0 standards, TIG team members will review the TIG v1.0 in the context of adoption within their organizations and complete the CDISC TIG online education curriculum. A volunteer-based TIG team will be formed to support, manage, and refine TIG standards over time. In general, prioritization will be given to the development of resources that support understanding and application of standards necessary for the generation and review of datasets required for MRP eSubmission. Training curricula specific to roles and key skillsets within FDA CTP and industry may be developed based on feedback.

Pilot Execution

Education needs will be assessed during pilot execution as feedback continues to be provided by team members. As in pilot preparation, feedback will drive and define education resource development and provision to team members. Prioritization given to resources supporting the understanding and application of standards for the generation and review of datasets required for MRP eSubmission. Training curricula specific to roles and key skillsets within FDA CTP and industry may be developed based on feedback.

Long-term Framework

Project use of educational resources and their perceived effectiveness will be assessed as part of a white paper summarizing the pilot experience with recommendations for future educational resources. Strategies for development and provision of resources will be documented as part of a framework to outline and guide next steps for long-term stakeholder collaboration, support, and enhancements to TIG v1.0 standards for subsequent use cases.

At a minimum the TIG v1.0 curriculum, including existing on-demand training, will be expanded as applicable to align with pilot learnings.