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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.
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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.
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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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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.
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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.
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The Association of Clinical Research Professionals (ACRP) interviewed Sandra “SAM” Sather on “Effective Quality Risk Management as a Mindset” July 8th. An ACRP Fellow, SAM shared her expertise on why the industry frequently misunderstands what is meant by risk-based monitoring (RBM) and quality systems. There is a misconception that clinical trials will either be done with RMB or traditional 100% SDV monitoring, when all trials need to have the approach of being based on risk.
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Due to the global pandemic, the Food and Drug Administration (FDA) temporarily stopped onsite inspections in March. In the interim, they have been conducting remote assessments following a risk-based approach. The FDA is planning to resume onsite domestic inspections the week of July 20th. During the reopening, the health and safety of all involved will be a priority, and any regional restrictions will be followed.
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Join Sandra “SAM” Sather as she presents an overview of the quality management of electronic systems in clinical trials for cross functional teams. It includes an important comparison of some of the FDA and EMA guidance and regulation, including recent guidance from EMA. This course can be used to conduct training for your teams and to help you plan and conduct a gap analysis of your current quality management system related to all stages of clinical trials.
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With clinical trial sites prolonging restricted access and sponsor or CRO monitors continuing to monitor clinical trials remotely, more clarification of how to proceed in the current environment while maintaining subject safety and data integrity and quality is needed. The Food and Drug Administration (FDA) released an updated COVID-19 clinical trial guidance with clarification on methods of obtaining informed consent from patients in isolation and an additional question and answer.
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Have you ever heard or stated, “We are not doing risk-based monitoring for this study”? This is using the term to refer to a style vs. a process to conduct monitoring based on risk. This means that there was a decision to conduct “traditional” monitoring, with 100 percent source data verification (SDV) and/or 100 percent data review of trial subjects.
