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Development of a CDISC Therapeutic Area Standard for Lung Cancer

Award Number: U01FD005854
ORGANIZATION: FOOD AND DRUG ADMINISTRATION
OPDIV: FDA
AWARD CLASS: COOPERATIVE AGREEMENT
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 09/10/2016
PERIOD OF PERFORMANCE END DATE: 04/30/2019

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Development of a CDISC Therapeutic Area Standard for Lung Cancer - Principal Investigator (Last, First, Middle): Kisler, Bron Witt Development of Oncology – Lung Cancer Data Standard Project Summary The objective of this project is to develop a global, non-proprietary data standard for Lung Cancer, utilizing the CDISC standards development process and the CDISC SHARE Metadata Repository. This project will lead to the development of specifications for that Therapeutic Area, which capture how to structure commonly collected data and outcome measurements in disease clinical trials. The Specific Aims of this project are:  Develop data standards for Lung Cancer clinical research studies using the CDISC standards development process.  Ensure alignment with the CDISC Study Data Tabulation Model (SDTM) for FDA electronic submissions  Code applicable oncology Concepts and controlled terminology in the NCI EVS terminology system  Use the CDISC SHARE Metadata Repository and other tools to support development of the Lung Cancer data standard.  Publish a Therapeutic Area Standard for Lung Cancer and make it publicly available via the CDISC Website. This project will be accomplished through several distinct stages in conjunction with major enhancements to the standards development process:  Stage 0 – Initiation and Scoping: Review and approval of project proposal and define scope.  Stage 1 – Identification a n d m o d e l i n g of CDISC Concepts: Create multi- disciplinary core team (including FDA contact), review available prior work, design concept maps, create new concept map templates, and perform gap analysis with existing CDISC constructs.  Stage 2 – Development of Draft Standards: Core team develops detailed metadata for SHARE in SDTM format, draft user guide. Education Content is developed in conjunction with Standards Development experts.  Stage 3a – Internal Review: Review of draft standards by relevant CDISC teams and experts in Lung Cancer.  Stage 3b – Public Review: Review of draft standards by general public for a minimum of 30 days, approve as a final production standard.  Stage 3c – Public Release: Data standard posted to CDISC website.  Develop Educational content specific for the Lung Cancer Standard oncology domains to educate users.  Throughout all stages, work with the SHARE team to determine tools to efficiently develop therapeutic area standards and improve availability of metadata in electronic format.


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: 2021 ( Subtotal = $0 )
2021	2017	CLINICAL DATA INTERCHANGE STANDARDS CONSORTIUM, INC	401 W 15TH ST STE 800	AUSTIN	TX	78701	TRAVIS	USA	Food and Drug Administration Research	000	2	3/25/2021	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2019 ( Subtotal = $0 )
2019	2017	CLINICAL DATA INTERCHANGE STANDARDS CONSORTIUM, INC	401 W 15TH ST STE 800	AUSTIN	TX	78701	TRAVIS	USA	Food and Drug Administration Research	000	2	11/2/2018	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2018 ( Subtotal = $0 )
2018	2017	CLINICAL DATA INTERCHANGE STANDARDS CONSORTIUM, INC	401 W 15TH ST STE 800	AUSTIN	TX	78701	TRAVIS	USA	Food and Drug Administration Research	000	2	7/18/2018	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2017 ( Subtotal = $186,565 )
2017	2017	CLINICAL DATA INTERCHANGE STANDARDS CONSORTIUM, INC	401 W 15TH ST STE 800	AUSTIN	TX	78701	TRAVIS	USA	Food and Drug Administration Research	003	2	9/27/2017	NON-COMPETING CONTINUATION	$136,557
2017	2017	CLINICAL DATA INTERCHANGE STANDARDS CONSORTIUM, INC	401 W 15TH ST STE 800	AUSTIN	TX	78701	TRAVIS	USA	Food and Drug Administration Research	002	2	8/29/2017	NON-COMPETING CONTINUATION	$50,008
2017	2016	CLINICAL DATA INTERCHANGE STANDARDS CONSORTIUM, INC	401 W 15TH ST STE 800	AUSTIN	TX	78701	TRAVIS	USA	Food and Drug Administration Research	000	1	10/28/2016	NEW	$0
2017	2016	CLINICAL DATA INTERCHANGE STANDARDS CONSORTIUM, INC	401 W 15TH ST STE 800	AUSTIN	TX	78701	TRAVIS	USA	Food and Drug Administration Research	001	1	5/3/2017	NEW	$0
														Subtotal = $186,565

Issue Date FY: 2016 ( Subtotal = $224,971 )
2016	2016	Clinical Data Interchange Standards Consortium	4488 Heritage Well Lane	ROUND ROCK	TX	78665	WILLIAMSON	USA	Food and Drug Administration Research	000	1	9/9/2016	NEW	$224,971
														Subtotal = $224,971

Grand Total All Awards = $411,536

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Development of a CDISC Therapeutic Area Standard for Lung Cancer

Award Number: U01FD005854

ORGANIZATION: FOOD AND DRUG ADMINISTRATION

OPDIV: FDA

AWARD CLASS: COOPERATIVE AGREEMENT

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

PERIOD OF PERFORMANCE START DATE: 09/10/2016

PERIOD OF PERFORMANCE END DATE: 04/30/2019

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