clinical research

Now Available: Clinical Pathways’ ICH E6(R3) Good Clinical Practice Training!

05/07/2025

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In the ever changing world of clinical research, staying up to date with the latest guidelines and best practices is crucial. Our ICH E6(R3) Good Clinical Practice Training is designed for busy professionals who want to deepen their knowledge on GCP to help ensure they meet the highest standards of quality, safety, and compliance.

FDA Warning Letter to Sponsor – Records, Reports, and Audit Trails

FDA Warning Letter to Sponsor – Records, Reports, and Audit Trails

04/22/2025

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In November 2024, the US Food and Drug Administration (FDA) issued a warning letter to the sponsor as a result of a BioResearch Monitoring Program (BIMO) inspection which observed objectionable conditions. The warning letter cited two violations of the Title 21 CFR.

OGPS and FDA discuss FDA’s Role in the DoH Revision

04/08/2025

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In December 2024, following the release of the 2024 revision of the Declaration of Helsinki (DoH), US Food and Drug Administration (FDA) staff shared the FDA’s perspective on what their role was in the development of the 2024 DoH and how it may impact FDA procedures. The DoH is intended to guide clinical research involving human participants that is often used as the foundation for other guidelines such as the International Council for Harmonisation (ICH) Good Clinical Practice (GCP).

WMA Adopts 2024 Revision of the Declaration of Helsinki

WMA Adopts 2024 Revision of the Declaration of Helsinki

03/24/2025

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In October 2024, the World Medical Association (WMA) announced the adoption of the 2024 revision of the Declaration of Helsinki (DoH) during the 75th WMA General Assembly in Helsinki, Finland, the same location where the Declaration was initially adopted 60 years prior.

IRB Warning Letter from BIMO Inspection

IRB Warning Letter from BIMO Inspection

03/10/2025

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On September 27, 2024, the US Food and Drug Administration (FDA) issued a warning letter to an Institutional Review Board (IRB) as a result of a (BIMO) inspection from July of 2023. BIMO inspections evaluate compliance with of FDA regulatory requirements, in this case, title 21 CFR Parts 50, protection of human subject, and 56, Intuitional Review Boards.