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In the ever changing world of clinical research, staying up to date with the latest guidelines and best practices is crucial. Our Major Changes in GCP from ICH E6(R2) to (R3): Road Map is designed for busy professionals who want to deepen their knowledge on GCP to help ensure they meet the highest standards of quality, safety, and compliance.
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In January 2025, the US Food and Drug Administration (FDA) published a draft guidance titled “Considerations for the Use of Artificial Intelligence (AI) to Support Regulatory Decision-Making for Drug and Biological Products” for trial sponsors and stakeholders intending to use AI to generate data and clinical evidence.
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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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On August 20th, 2024 the US Food and Drug Administration (FDA) issued a warning letter as a result of an FDA Bioresearch Monitoring (BIMO) Program inspection. The inspection observation was that improper dosing instructions were given to a pediatric patient. Per 21 CFR 312.60, the investigator is responsible for ensuring the study is conducted according to the protocol.
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On August 8, 2023, the U.S. Food and Drug Administration (FDA) issued an investigator Warning Letter to Angela M. Stupi, M.D.. There were multiple deficiencies noted at Dr. Stupi’s clinical site. The site enrolled participants who were ineligible per protocol and did not follow the requirements for administering the investigation product.
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An investigator was recently issued a warning letter due to noncompliance with the IRT, which can impact the safety of the participants and the quality and integrity of the data. Per protocol, IP was to be administered according to hemoglobin levels and the IRT was to randomize the doses appropriately.
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Do you ever wonder why people are not doing what you expect? How do you figure out what went wrong and what constraints are getting in the way of everything working as it should? You may have heard that you need to ask the right question, or even about the Five Whys. But if you have used the Five Whys before, have you noticed that you are not confident in the results?
