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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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During the current COVID-19 pandemic, it has become necessary for sponsors of clinical trials to rely on remote methods to access electronic health records and electronic source data. With risk-based monitoring becoming more common, and with sponsor/CRO monitors reviewing electronic source data remotely, many questions have arisen regarding what security measures need to be in place to ensure the protection of study participants’ data. Here is one such question.
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As sponsor or CRO monitors are continuing to monitor clinical trial sites remotely for the foreseeable future, additional clarification is needed for how to proceed while protecting subject safety and data integrity. The Food and Drug Administration (FDA) released an updated COVID-19 clinical trial guidance with clarification on the requirements for the investigator to review IND safety reports. The question and answer guidance shows how we must be very careful to not decrease the safety protection checks and balances we have in GCP between stakeholders.
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Sandra “SAM” Sather will be speaking at the Society of Quality Assurance (SQA) September Virtual Meeting and Quality College on the topics:
Quality Risk Management Not an Option, But A Mindset, What Are We Learning During COVID-19
Remote Operations and Maintaining HIPAA, GDPR, GCP, and COVID-19
When: September 21 and 22, 2020
Where: Virtual
Schedule: HERE
Register: HERE
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When: September 17, 2020
Time: Live from 1-2 PM EDT
Register: HERE
Released in July 2020, ISO 14155:2020 is the third version of the standards that provides direction on how to implement GCP for medical device clinical investigations. The changes in this revision are designed to ensure that ISO standards are up to date with regulatory changes in the industry.
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On April 7, 2020, the European Medicines Agency (EMA) released a Notice to sponsors on validation and qualification of computerized systems used in clinical trials. This guidance is applicable for clinical trials conducted in the EU and clarifies that even though a sponsor may delegate all or part of clinical trial activities out to a company, the ultimate responsibility for validation of software tools or electronic systems remains with the sponsor. This guidance also clarifies that most vendors focus on system security of the participant’s personal data, but they lack a focus on how an electronic system used in a clinical trial must comply with Good Clinical Practice (GCP) and the documentation principles of ALCOA+.
