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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

critical thinking

RBQM Community Discussion Outcomes from MCC vSummit 2020

10/20/2020

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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.

Why Did Five Whys Lead Me Here?

3/03/2020

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You may be accustomed to using the Five Whys method for root cause analysis. You ask ‘Why’ five times in an effort to discover the root cause of an issue. If this is your go-to method, you may not realize that there is a different tool available or that Five Whys may be ineffective or outdated. After all, manufacturers of calculators at first had a difficult time convincing consumers of the value of a calculator when they were used to a slide rule. Could you imagine if everyone stuck to what they were comfortable with instead of trying something new?