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Development of Prostate Cancer Standards

Award Number: U24FD005243
ORGANIZATION: FOOD AND DRUG ADMINISTRATION
OPDIV: FDA
AWARD CLASS: COOPERATIVE AGREEMENT
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 09/15/2014
PERIOD OF PERFORMANCE END DATE: 02/28/2017

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Development of Prostate Cancer Standards - Project Summary The objective of this project is to develop global, non-proprietary CDISC data standards for Prostate Cancer, utilizing the CDISC standards development process. Sophisticated analyses are severely limited by the lack of therapeutic area data standards, despite the billions of dollars invested in Prostate Cancer research. The Specific Aims of this project include: · Working through existing partnerships (e.g. FDA, NCI) and with the broader clinical research community to develop CDISC data standard(s) for Prostate Cancer and Oncology using the CDISC standards development process [1]; · Ensuring alignment with the SDTM standard for regulatory submissions and CDASH standard for data collection in clinical trials; · Through our long-standing partnership with NCI Enterprise Vocabulary Services (EVS), providing applicable oncology research concepts and controlled terminology coded in the NCI EVS terminology system; · Providing the Prostate Cancer / Oncology data standard in electronic form through the CDISC SHARE metadata repository [2]; · Publishing applicable User Guides for SDTM and CDASH, making them publicly available through the CDISC website. This project will be accomplished through several distinct stages: · Stage 0 – Initiation and Scoping: Review and approval of project proposal and define scope. · Stage 1 – Identification of Research Concepts: Create multi-disciplinary core team (including FDA contact), review available prior work, design concept maps, 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. · Stage 3.1 – Internal Review: Review of draft standards by relevant CDISC teams and experts in Prostate Cancer. · Stage 3.2 – Public Review: Review of draft standards by general public for a minimum of 30 days, approve as a final production standard. · Stage 3.3 – Public Release: Data standard posted to CDISC website.


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: 2017 ( Subtotal = $0 )
2017	2015	CLINICAL DATA INTERCHANGE STANDARDS CONSORTIUM, INC	401 W 15TH ST STE 800	AUSTIN	TX	78701	TRAVIS	USA	Food and Drug Administration Research	000	2	12/13/2016	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2016 ( Subtotal = $0 )
2016	2015	Clinical Data Interchange Standards Consortium	4488 Heritage Well Lane	ROUND ROCK	TX	78665	WILLIAMSON	USA	Food and Drug Administration Research	000	2	7/19/2016	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2015 ( Subtotal = $115,597 )
2015	2015	Clinical Data Interchange Standards Consortium	4488 Heritage Well Lane	ROUND ROCK	TX	78665	WILLIAMSON	USA	Food and Drug Administration Research	001	2	8/26/2015	NON-COMPETING CONTINUATION	$115,597
2015	2014	Clinical Data Interchange Standards Consortium	4488 Heritage Well Lane	ROUND ROCK	TX	78665	WILLIAMSON	USA	Food and Drug Administration Research	000	1	8/26/2015	NEW	$0
														Subtotal = $115,597

Issue Date FY: 2014 ( Subtotal = $220,742 )
2014	2014	Clinical Data Interchange Standards Consortium	4488 Heritage Well Lane	ROUND ROCK	TX	78665	WILLIAMSON	USA	Food and Drug Administration Research	000	1	9/14/2014	NEW	$220,742
														Subtotal = $220,742

Grand Total All Awards = $336,339

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Development of Prostate Cancer Standards

Award Number: U24FD005243

ORGANIZATION: FOOD AND DRUG ADMINISTRATION

OPDIV: FDA

AWARD CLASS: COOPERATIVE AGREEMENT

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

PERIOD OF PERFORMANCE START DATE: 09/15/2014

PERIOD OF PERFORMANCE END DATE: 02/28/2017

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