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HIV/AIDS Clinical Trials Network Statistical and Data Management Centers

Forecast
Grant

Contract Overview

Solicitation details, issuing organization, response deadlines, documents, and interested companies for this government contract opportunity.

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The National Institute of Allergy and Infectious Diseases, under the National Institutes of Health, is seeking applications for up to four Statistical and Data Management Centers to lead Clinical Trials Networks focused on HIV and HIV-associated diseases. These centers will be responsible for developing and implementing research agendas aimed at ending the HIV epidemic by coordinating study design, execution, and the analysis of clinical and laboratory data. The selected centers will work alongside Leadership and Operations Centers, Laboratory Centers, and Clinical Trials Units to ensure data quality, regulatory compliance, and the use of innovative statistical methods and validated data capture systems. This forecast is issued under the authority of the Public Health Service Act and relevant federal regulations. The project falls under NAICS code 541720 and is managed by the Division of AIDS within the Department of Health and Human Services. The primary objective is to advance prevention, treatment, and implementation research through harmonized data practices and adherence to NIH data sharing policies.

General Info

NIAID seeks up to four SDMCs to manage HIV clinical trials, data, and regulatory compliance.

Agency

Department Of Health And Human Services → National Institutes Of Health

NAICS

541720 - Research and Development in the Social Sciences and Humanities

Place of Performance

Not specified

Set-Aside

NONE

Documents

0

No documents available

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Timeline

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Posted

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Organization & Contact Information

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AgencyDepartment Of Health And Human Services → National Institutes Of Health
Contacts1 person available
OfficeUSA
Organization / AgencyDepartment Of Health And Human Services → National Institutes Of Health
Office AddressUSA
Contacts
Division of AIDS
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Full Description

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The National Institute of Allergy and Infectious Diseases (NIAID) seeks to advance the National Institutes of Health (NIH) mission by supporting four Clinical Trials Networks (CTNs) each comprised of a Leadership and Operations Center, Statistical and Data Management Center (SDMC), and Laboratory Center (LC) working with Clinical Trials Units (CTUs), to advance prevention, treatment, and implementation research on HIV and HIV-associated diseases. This NOFO will solicit applications for up to four SDMCs to provide leadership for developing and implementing each CTN research agenda with the goal of ending the HIV epidemic. Each SDMC will coordinate study design and execution, including data collection, monitoring, and analyses. SDMCs manage clinical and laboratory data submitted by CTUs and the LC ensuring data quality, regulatory compliance, and continual reporting of protocol and site performance. SDMCs foster innovative trial design and statistical methods, statistical and data practices harmonization, and ensure validated systems for data capture and integration, according to NIH data sharing policies.

Grant authorities that allow NIAID to forecast this opportunity are as follows: Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR Part 52 and 2 CFR Part 200.

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