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EMA on the use of Real-World Data/Evidence in ...

04/30/2025

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In March, 2025, the European Medicines Agency (EMA) released a “Reflection paper on use of real-world data (RWD) in non-interventional studies (NIS) to generate real-world evidence (RWE) for regulatory purposes” as a guidance for stakeholders on quality planning, conduct and analysis of NISs that intend to use RWD to generate RWE.

EMA on the use of Real-World Data/Evidence in Non-Interventional Studies
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FDA Warning Letter to Sponsor – Records, ...

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.

FDA Warning Letter to Sponsor – Records, Reports, and Audit Trails
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OGPS and FDA discuss FDA’s Role in the DoH ...

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).

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WMA Adopts 2024 Revision of the Declaration of ...

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.

WMA Adopts 2024 Revision of the Declaration of Helsinki
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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.

IRB Warning Letter from BIMO Inspection

Clinical Trials eSystems Draft Guidance Plus Team Training Available

05/02/2023

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The US Food and Drug Administration (FDA) released a draft guidance “Electronic Systems, Electronic Records, and Electronic Signatures in Clinical Investigations: Questions and Answers” in March 2023. When finalized, it will replace the 2007 guidance “FDA Computerized Systems Used in Clinical Investigations.”  The FDA regulates electronic systems, electronic records, and electronic signatures used by sponsors and CROs to create records required for clinical trials per 21 CFR Part 11.

Risk Based Monitoring Q&A Guidance

04/25/2023

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The US Food and Drug Administration (FDA) released a final questions and answers guidance document, “A Risk-Based Approach to Monitoring of Clinical Investigations” in April 2023. It includes recommendations for developing a monitoring approach and the content of the monitoring plan, and follow up and communication of the monitoring results. The questions and answers guidance is a companion to the “Oversight of Clinical Investigations – A Risk-Based Approach to Monitoring” guidance from August 2013.

Sponsor Oversight of Decentralized Clinical Trials

04/11/2023

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Decentralized clinical trials (DCTs) have increased in popularity during the pandemic. The US Food and Drug Administration (FDA) released guidance on Conduct of Clinical Trails of Medical Products During the COVID-19 Public Health Emergency that clarified that decentralization of clinical trials through remote collection of data outside of a physical location is permissible as long as methods follow regulatory requirements.

IRB Receives FDA Warning Letter

03/28/2023

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Recently, a community hospital Institutional Review Board (IRB) received a US Food and Drug Administration (FDA) warning letter for lack of appropriate members present to review research, inadequate documentation, and inadequate informed consent review.