NIH Reporter #2UC7AI095321-13

NEIDL Regulatory Compliance Core

Award to Boston University Medical Campus for the NEIDL Regulatory Compliance Core to support regulatory compliance and data integrity in high-containment infectious disease research, with a focus on FDA licensure-enabling studies and national preparedness.

Description

The Regulatory Compliance (RC) Core provides the governance, oversight, and data-integrity framework that enables the NEIDL to conduct licensure-enabling studies for medical countermeasures targeting pathogens requiring maximum biocontainment. It ensures compliance with FDA regulations, including GLP, the Animal Rule, and Part 11. The RC Core integrates various units into a unified structure, with Study Directors serving as the single point of control for study conduct and data integrity, and PIs providing scientific oversight and institutional compliance. Over the next 5 years, the RC Core will expand radiotelemetry use in non-human primate studies, validate computerized systems for full Part 11 compliance, advance assay qualification, and complete the transition to ZenQMS for SOP lifecycle, training, and audit management. It will sustain a competency-based, two-tiered training program to ensure personnel maintain current and validated qualifications. These activities will connect academic discovery and industry innovation to regulatory frameworks, ensuring the NEIDL remains capable of conducting Animal Rule compliant studies in BSL-4 containment and strengthening national preparedness against emerging infectious diseases.

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