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Data and Statistical Coordinating Center (DSCC) for the Collaborative Islet Transplant Registry (CITR)

Award Number: UC4DK114839
ORGANIZATION: NATIONAL INSTITUTE OF DIABETES & DIGESTIVE & KIDNEY DISEASES
OPDIV: NIH
AWARD CLASS: COOPERATIVE AGREEMENT
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 09/01/2017
PERIOD OF PERFORMANCE END DATE: 05/31/2022

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Data and Statistical Coordinating Center (DSCC) for the Collaborative Islet Transplant Registry (CITR) - Project Summary This application, in response to RFA-DK-16-503, describes a comprehensive Data and Statistical Coordinating Center (DSCC) for the Collaborative Islet Transplant Registry (CITR) for 2017-2022. Continuing from 2013- 2017 as the CITR-DSCC, The Emmes Corporation will collaborate with the NIDDK Program Office, the Oversight Committee and the CITR investigators to support the established CITR Registry of allogeneic and autologous pancreatic islet transplantation, as well as any other beta cell replacement therapies that should be followed for efficacy and safety in the resolution of refractory glycemic lability marked by severe hypoglycemic episodes in persons with Type 1 diabetes or lacking pancreatic islets for any reason including therapeutic pancreatectomy or any loss of islet cell function. The aims of the CITR DSCC will be to maintain and expand: 1) Collaboration and communication among stakeholders in allo- and auto- islet transplantation, total pancreatectomy alone (TPA), and any other study groups approved by the NIDDK Program Office, to advance collection of the appropriate data and dissemination of timely and useful results for the medical care community. 2) Identifying all sites active in allogeneic or autologous ITx, or total pancreatectomy alone (TPA), in the existing CITR geographical regions to invite their registration in CITR, contribution of their data, and participation in organizational, scientific and analytic activities, and expand CITR’s geographical regions as may be indicated by the Program Office. 3) Providing mechanism(s) for securely and confidentially collecting and reporting data on any clinical beta-cell replacement or artificial pancreas therapies, through the existing CITR data and study administration portal. For CITR, this comprises an internet-based system including CITR-specific electronic case report forms (CRFs), electronic data uploads, built-in, customized data quality procedures, and real-time, professional management of data quality issues including resolution of errors detected from range checks and logical consistency checks, in a 21 CFR-compliant database for internal and external research efforts. 4) Providing biostatistical leadership to answer CITR committee and investigator-initiated research questions utilizing the CITR database, for publication in peer-reviewed journals, presentation at national and international scientific meetings in diabetes and transplantation, and use by the participating sites. 5) Providing continued logistical support to a NIDDK-designated Data and Safety Monitoring Board. 6) Providing the administrative, organizational and contractual support necessary to conduct all the activities of the CITR.


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: 2023 ( Subtotal = -$41,376 )
2023	2017	THE EMMES COMPANY LLC	401 N WASHINGTON ST, STE 700	ROCKVILLE	MD	20850	MONTGOMERY	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	000	1	10/1/2022	NEW	-$41,376
														Subtotal = -$41,376

Issue Date FY: 2022 ( Subtotal = $0 )
2022	2017	EMMES COMPANY, LLC, THE	401 N WASHINGTON ST STE 700	ROCKVILLE	MD	20850	MONTGOMERY	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	000	1	10/27/2021	NEW	$0
														Subtotal = $0

Issue Date FY: 2021 ( Subtotal = $0 )
2021	2017	EMMES COMPANY, LLC, THE	401 N WASHINGTON ST STE 700	ROCKVILLE	MD	20850	MONTGOMERY	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	000	1	8/26/2021	NEW	$0
														Subtotal = $0

Issue Date FY: 2017 ( Subtotal = $2,734,163 )
2017	2017	EMMES CORPORATION, THE	401 N WASHINGTON ST STE 700	ROCKVILLE	MD	20850	MONTGOMERY	USA	Diabetes, Digestive, and Kidney Diseases Extramural Research	000	1	9/1/2017	NEW	$2,734,163
														Subtotal = $2,734,163

Grand Total All Awards = $2,692,787

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Data and Statistical Coordinating Center (DSCC) for the Collaborative Islet Transplant Registry (CITR)

Award Number: UC4DK114839

ORGANIZATION: NATIONAL INSTITUTE OF DIABETES & DIGESTIVE & KIDNEY DISEASES

OPDIV: NIH

AWARD CLASS: COOPERATIVE AGREEMENT

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

PERIOD OF PERFORMANCE START DATE: 09/01/2017

PERIOD OF PERFORMANCE END DATE: 05/31/2022

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