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Adverse Event & Unanticipated Problem (AE/UP) Reporting System

Active

Federal

Contract Overview

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

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The contract involves the development and management of a system designed to facilitate the expedited reporting of adverse events and unanticipated problems, ensuring compliance with the National Heart, Lung, and Blood Institute (NHLBI) policy as well as federal safety monitoring standards. This subcontract focuses on creating a reliable and efficient reporting mechanism to enhance timely communication and tracking of safety concerns within the scope of NHLBI's regulatory framework. Issued by the National Institutes of Health under the Department of Health and Human Services, the contract aligns with NAICS code 541611, which pertains to administrative management and general management consulting services. Although specific location details and contact points are not provided, the emphasis lies on adherence to stringent safety reporting requirements to support the NHLBI's mission in safeguarding public health through vigilant monitoring of clinical research outcomes and other related activities.

General Info

Develop and manage a system for expedited adverse event reporting per NHLBI and federal standards.

Agency

Department Of Health And Human Services → National Institutes Of Health NhlbiView Agency

NAICS

541611 - Administrative Management and General Management Consulting ServicesView NAICS

Place of Performance

MD, USA

Set-Aside

NONE

Documents

This scope was carved out of 75N92026R00008.

The full solicitation package (1 document), including the RFP, is on the prime solicitation, not on this scope.

View the prime solicitation

A--Study Coordinating Center for Lung Health Cohort

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Timeline

PostedApr 16

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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 / Agency

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

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Office AddressN/A

ContactsNo contact information available

Full Description

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Implement and manage a system for expedited reporting of adverse events and unanticipated problems in compliance with NHLBI policy and federal safety monitoring requirements.

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