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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.

Award Number: U24FD007488
ORGANIZATION: FOOD AND DRUG ADMINISTRATION
OPDIV: FDA
AWARD CLASS: COOPERATIVE AGREEMENT
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 12/01/2021
PERIOD OF PERFORMANCE END DATE: 11/30/2024

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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. - 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.


Issue Date FY	Funding FY	Legal Entity Name	Legal Entity Address	Legal Entity City	Legal Entity State	Legal Entity Zip Code	Legal Entity COUNTY	Legal Entity COUNTRY	Assistance Listing	Award Code	Budget Year	Action Date	Action Type	Action Amount

Issue Date FY: 2025 ( Subtotal = $0 )
2025	2023	CLINICAL DATA INTERCHANGE STANDARDS CONSORTIUM INC	401 W 15TH ST STE 520	AUSTIN	TX	78701	TRAVIS	USA	Food and Drug Administration Research	000	2	4/8/2025	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2024 ( Subtotal = $0 )
2024	2023	CLINICAL DATA INTERCHANGE STANDARDS CONSORTIUM INC	401 W 15TH ST STE 520	AUSTIN	TX	78701	TRAVIS	USA	Food and Drug Administration Research	001	2	11/1/2023	SUPPLEMENT FOR EXPANSION	$0
2024	2023	CLINICAL DATA INTERCHANGE STANDARDS CONSORTIUM INC	401 W 15TH ST STE 520	AUSTIN	TX	78701	TRAVIS	USA	Food and Drug Administration Research	000	2	11/1/2023	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2023 ( Subtotal = $414,246 )
2023	2023	CLINICAL DATA INTERCHANGE STANDARDS CONSORTIUM, INC	401 W 15TH ST STE 800	AUSTIN	TX	78701	TRAVIS	USA	Food and Drug Administration Research	002	2	8/14/2023	SUPPLEMENT FOR EXPANSION	$182,837
2023	2023	CLINICAL DATA INTERCHANGE STANDARDS CONSORTIUM, INC	401 W 15TH ST STE 800	AUSTIN	TX	78701	TRAVIS	USA	Food and Drug Administration Research	000	2	11/1/2022	NON-COMPETING CONTINUATION	$231,409
2023	2023	CLINICAL DATA INTERCHANGE STANDARDS CONSORTIUM, INC	401 W 15TH ST STE 800	AUSTIN	TX	78701	TRAVIS	USA	Food and Drug Administration Research	001	2	1/17/2023	NON-COMPETING CONTINUATION	$0
														Subtotal = $414,246

Issue Date FY: 2022 ( Subtotal = $230,834 )
2022	2022	CLINICAL DATA INTERCHANGE STANDARDS CONSORTIUM, INC	401 W 15TH ST STE 800	AUSTIN	TX	78701	TRAVIS	USA	Food and Drug Administration Research	001	1	12/16/2021	NEW	$0
2022	2022	CLINICAL DATA INTERCHANGE STANDARDS CONSORTIUM, INC	401 W 15TH ST STE 800	AUSTIN	TX	78701	TRAVIS	USA	Food and Drug Administration Research	000	1	11/11/2021	NEW	$230,834
														Subtotal = $230,834

Grand Total All Awards = $645,080

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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.

Award Number: U24FD007488

ORGANIZATION: FOOD AND DRUG ADMINISTRATION

OPDIV: FDA

AWARD CLASS: COOPERATIVE AGREEMENT

AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)

PERIOD OF PERFORMANCE START DATE: 12/01/2021

PERIOD OF PERFORMANCE END DATE: 11/30/2024

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