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Study Protocol Development and Data Coordination

Active
Federal

Contract Overview

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

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This subcontract for Study Protocol Development and Data Coordination supports prime contractors on multi-site studies for the National Institutes of Health NHLBI. The scope of work involves providing technical writing and data architecture services, specifically focusing on the development of standardized study protocols, consent forms, and data collection instruments for interviews. Additionally, the contractor is responsible for managing the flow of data from various field sites to central repositories using specialized research software and data management systems. The project is based in Bethesda and requires strict adherence to HIPAA compliance and Good Clinical Practice guidelines. The primary deliverables include approved study protocols and a fully functional data collection system. This opportunity falls under NAICS code 541511 and is managed under the Department of Health and Human Services.

General Info

Subcontract for NIH NHLBI providing technical writing, data architecture, and HIPAA-compliant data management.

Agency

Department Of Health And Human Services → National Institutes Of Health Nhlbi

NAICS

541511 - Custom Computer Programming Services

Place of Performance

Bethesda, MD, 20892, USA

Set-Aside

NONE

Documents

This scope was carved out of 75N98026R00073.

The full solicitation package (2 documents), including the RFP, is on the prime solicitation, not on this scope.

View the prime solicitation

Strong Heart Study (SHS) – New Cohort of Young Native American (NA) Adults

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Timeline

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Organization & Contact Information

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AgencyDepartment Of Health And Human Services → National Institutes Of Health Nhlbi
ContactsNo contacts available
OfficeN/A
Organization / AgencyDepartment Of Health And Human Services → National Institutes Of Health Nhlbi
Office AddressN/A
ContactsNo contact information available

Full Description

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Performs technical writing and data architecture for prime contractors on NIH NHLBI multi-site studies. Develops standardized study protocols and consent forms, designs data collection instruments for interviews, and manages data flow from field sites to central repositories. Requires specialized research software and data management systems. Adheres to HIPAA compliance and Good Clinical Practice (GCP) guidelines. Delivers approved study protocols and a functional data collection system.

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