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Developing Acute Kidney Injury CDISC Clinical Data Standards for Clinical Research and Drug Development.

Award Number: U24FD006491
ORGANIZATION: FOOD AND DRUG ADMINISTRATION
OPDIV: FDA
AWARD CLASS: COOPERATIVE AGREEMENT
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 09/01/2018
PERIOD OF PERFORMANCE END DATE: 11/30/2020

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Developing Acute Kidney Injury CDISC Clinical Data Standards for Clinical Research and Drug Development. - Project Summary/Abstract CDISC has developed foundational standards over the last twenty years and published thirty-five Therapeutic Area (TA) standards and updates for the past five years in collaboration with FDA- CDER, in addition eleven TA standards are currently in development through a community-driven, consensus-based process in collaboration with CFAST organizations and the CDISC global community of reviewers. The objectives of this project are to build on existing CDISC clinical data standards to develop vasomotor symptoms due to menopause standards that span collection (CDASH), organization (SDTM), analysis (ADaM), controlled terminology, as well as develop a number of relevant Questionnaires, Ratings or Scales (QRS), using established CDISC processes and CDISC SHARE tools. CDISC will engage CFAST stakeholders as well as the CDISC global community in the development of these new vasomotor symptoms due to menopause standards. The new vasomotor symptoms due to menopause standards will bring clarity to data and support FDA in reviewing many different studies and allowing them to ‘speak the same language’.


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 = -$13,409 )
2021	2019	CLINICAL DATA INTERCHANGE STANDARDS CONSORTIUM, INC	401 W 15TH ST STE 800	AUSTIN	TX	78701	TRAVIS	USA	Food and Drug Administration Research	000	2	4/2/2021	NON-COMPETING CONTINUATION	-$13,409
														Subtotal = -$13,409

Issue Date FY: 2020 ( Subtotal = $0 )
2020	2019	CLINICAL DATA INTERCHANGE STANDARDS CONSORTIUM, INC	401 W 15TH ST STE 800	AUSTIN	TX	78701	TRAVIS	USA	Food and Drug Administration Research	001	2	8/5/2020	NON-COMPETING CONTINUATION	$0
2020	2019	CLINICAL DATA INTERCHANGE STANDARDS CONSORTIUM, INC	401 W 15TH ST STE 800	AUSTIN	TX	78701	TRAVIS	USA	Food and Drug Administration Research	000	2	11/18/2019	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2019 ( Subtotal = $99,921 )
2019	2019	CLINICAL DATA INTERCHANGE STANDARDS CONSORTIUM, INC	401 W 15TH ST STE 800	AUSTIN	TX	78701	TRAVIS	USA	Food and Drug Administration Research	001	2	7/19/2019	NON-COMPETING CONTINUATION	$99,921
2019	2018	CLINICAL DATA INTERCHANGE STANDARDS CONSORTIUM, INC	401 W 15TH ST STE 800	AUSTIN	TX	78701	TRAVIS	USA	Food and Drug Administration Research	000	1	3/21/2019	NEW	$0
														Subtotal = $99,921

Issue Date FY: 2018 ( Subtotal = $249,725 )
2018	2018	CLINICAL DATA INTERCHANGE STANDARDS CONSORTIUM, INC	401 W 15TH ST STE 800	AUSTIN	TX	78701	TRAVIS	USA	Food and Drug Administration Research	000	1	7/16/2018	NEW	$249,725
														Subtotal = $249,725

Grand Total All Awards = $336,237

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Developing Acute Kidney Injury CDISC Clinical Data Standards for Clinical Research and Drug Development.

Award Number: U24FD006491

ORGANIZATION: FOOD AND DRUG ADMINISTRATION

OPDIV: FDA

AWARD CLASS: COOPERATIVE AGREEMENT

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

PERIOD OF PERFORMANCE START DATE: 09/01/2018

PERIOD OF PERFORMANCE END DATE: 11/30/2020

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