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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 HIPAA Privacy Rule is frequently used as the reason for not allowing data to be shared, even when the participant’s HIPAA authorization states allowance of disclosing PHI, including remotely or virtually. The Office for Civil Rights (OCR) released a February Bulletin on HIPAA and COVID-19 to clarify how Protected Health Information (PHI) can be shared while still maintaining privacy during the crisis.
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Topic: Critical Documentation of Clinical Trial Activities and CAPA During and Post COVID-19 Restrictions
When: June 2, 2020
Time: 1:00 p.m. – 2:00 p.m. EDT
Register: By clicking here
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As clinical research professionals proceed to work around COVID-19 restrictions while maintaining GCP, questions continue to arise. On May 11th, the Food and Drug Administration (FDA) released an updated Q&A section of their COVID-19 clinical trial guidance with three additional questions and answers included.
Some questions of note from the last two updates are:
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As we are settling into the new normal of COVID-19 restrictions, many are still unsure how to proceed to maintain subject safety and data integrity and face decisions on whether to continue clinical trials, suspend them, or even start a new trial. Questions remain about how to securely monitor source data remotely while maintaining data privacy and following regulations, and new issues became evident, such as how subjects could receive investigational product at home. There are many sources of information to guide sites and sponsors/CROs through these challenges.
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The recent COVID-19 outbreak has disrupted clinical trials drastically. Monitors are grounded but data still needs to be monitored. Despite the FDA, OCR, and EMA guidance, the question remains – how do we do this without putting our monitors or trial subjects at risk while staying compliant?
