Electronic Regulatory System

Abbreviation: eReg

Definition

An Electronic Regulatory System (eReg) is a digital platform used to manage essential regulatory documents and compliance records for clinical trials.

eReg systems typically support document storage, version control, access management, and standardized filing structures for oversight documentation. They help sites and sponsors maintain approvals, delegation logs, training records, correspondence, and other essential artifacts in an organized manner. Validated platforms improve transparency and reduce the risk of missing or outdated documentation. Strong eReg governance supports audit readiness and consistent regulatory recordkeeping throughout the study lifecycle.

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