Articles tagged with “irb”

FDA BIMO Inspection Trends, FY2015-FY2024: Data Atlas

A 2026 data atlas of FDA BIMO inspections by fiscal year, inspected party and classification, with source-deck revisions, denominator rules, observation families and control priorities.

21 min read

9/24/2026

fda bimo inspection trends bioresearch monitoring fda inspections clinical investigator sponsor cro irb glp bioequivalence inspection classifications

What is an IRB? The Role of Ethics Committees in Research

Explore the critical role of an IRB/IEC in protecting human subjects. Learn how ethics committees review and approve clinical trials per key ethical regulations including ICH E6(R3), the 2024 Declaration of Helsinki, and EU CTIS requirements

45 min read

11/19/2025

irb ethics committee clinical trials human subjects protection informed consent common rule ich-gcp research ethics belmont report

Clinical Trial Acronyms: A Guide to GCP, ICH, IRB & EDC

Learn about key clinical trial acronyms. This guide explains the definitions, history, and roles of GCP, ICH, IRB, EDC, and eTMF in clinical research. Updated with ICH E6(R3) finalization (2025), FDA DCT guidance, and current market data.

45 min read

11/18/2025

clinical trials good clinical practice gcp ich irb edc etmf regulatory compliance clinical research