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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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Sandra “SAM” Sather lead a community discussion at Metrics Champion Consortium’s (MCC) vSummit 2020 on “The Risk-Based Monitoring Training Gap,” related to her prerecorded session on “The RBM Training Gap: Risk-Based Monitoring the Noun vs. the Verb.” The conversation was informative as to where different organizations lie on the spectrum of implementing risk-based quality management (RBQM), with attendees from large sponsors explaining that they may have policies that require them to implement 100% source data verification (SDV) regardless of risk assessment for pre-phase III trials and attendees from small to mid-sized organizations commenting that they understand the need for risk-based monitoring plans but sometimes meet challenges cross functionally.
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In this podcast “Optimizing Human Performance in Clinical Trials by Applying Gilbert’s Behavioral Engineer Model”, host Linda Sullivan of Metrics Champion Consortium (MCC) chats with Sandra “SAM” Sather of Clinical Pathways about how SAM uses performance improvement science to support clients in implementation of major changes in clinical trials, proactively and reactively. For example, HIPAA, risk management, and recently, remote monitoring during the pandemic.
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The European Medicines Agency (EMA) has a Good Clinical Practice (GCP) FAQ site which is updated on an ongoing basis. The EMA offers guidance in the form of questions and answers (Q&As) on GCP as approved by the GCP Inspectors Working Group.
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Have you visited the European Medicines Agency’s (EMA) Frequently Asked Questions (FAQ) page? It is a valuable resource for sponsors and CROs participating in global trials in reference to Good Clinical Practice (GCP) in the context of the 28 countries of the European Union.
On this site, the EMA has published answers to the most frequently asked questions it has received and organized them into 11 categories.
