This Cooperative Agreement award from the Food and Drug Administration (FDA) Research program (CFDA 93.103) provides $499,844 in funding to the Clinical Data Interchange Standards Consortium Inc. (Cdisc), a non-profit organization that develops data standards for the healthcare industry. The project aims to support the adoption and further refinement of the Tobacco Implementation Guide Version 1.0 (TIG v1.0) CDISC standards for submissions to the FDA's Center for Tobacco Products (CTP). Key objectives include:
- Initiating a stakeholder-driven e-submission pilot to promote adoption of the TIG v1.0 standards for regulatory submissions to CTP.
- Developing a framework for long-term collaboration, support, and refinements to the TIG v1.0 standards to meet ongoing data standardization needs.
- Creating educational content to promote understanding of the value of data standards in tobacco research and support consistent implementation of the TIG v1.0 standards.
The project leverages Cdisc's expertise in developing open, consensus-based data standards and its established governance processes to engage stakeholders and enhance the regulatory review process for tobacco product submissions.
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