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FDA BIMO Inspection Results in Warning Letter

02/19/2025

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On October 10, 2024, the US Food and Drug Administration (FDA) issued a Warning Letter to a clinical investigator due to objectionable conditions observed during a Bioresearch Monitoring (BIMO) Program inspection in 2023. The warning letter addresses multiple violations to Title 21 of the Code of Federal Regulations (CFR).

FDA BIMO Inspection Results in Warning Letter
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The Fourth Edition of ISO 14155 Coming Soon

02/04/2025

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The International Standard ISO 14155 “Clinical Investigation of Medical Devices for Human Subjects – Good Clinical Practice” outlines what is considered good clinical practice for the design, conduct, recording, and reporting of clinical investigations of medical devices in human participants. As we enter 2025, a Draft International Standard (DIS) of ISO 14155 is in the final stages of the approval process and is expected to be released within the coming months to replace the existing ISO

The Fourth Edition of ISO 14155 Coming Soon
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New GCP Book Coauthored by Clinical Pathways ...

01/29/2025

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In November 2024, the CRC press published the first edition of “Good Clinical Practices in Pharmaceuticals” edited by Graham P. Bunn (President of GB Consulting, LLC) and authored by multiple clinical trial professionals, including Clinical Pathways’ own Jennifer Lawyer and Sandra “Sam” Sather. The book is a compendium of information regarding the Good Clinical Practice (GCP) guidelines including the standards, methodologies, laws, and regulations.

New GCP Book Coauthored by Clinical Pathways Now Available
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New Draft Guidance on Protocol Deviation ...

01/21/2025

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The guidance breaks down the roles and responsibilities of the investigator, sponsor, and Institutional Review Board (IRB) in regards to monitoring, mitigating, reporting, and evaluating protocol deviations (PDs). The investigator, who is responsible for the conduct of the trial and protection of the rights, safety, and welfare of the participants must report all PDs to the sponsor, highlighting the important PDs.

New Draft Guidance on Protocol Deviation Management Part 2/2
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ICH E6(R3) Progresses into Step Four

01/15/2025

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On January 6, 2025, the International Council of Harmonisation’s ICH E6(R3) for Good Clinical Practices (GCP) reached step four of the formal ICH procedure. This means that the ICH E6(R3) draft guidelines, since its release in May of 2023, were submitted to and approved by the ICH Regulatory Members of the ICH Assembly for adoption as an ICH Harmonised Guideline replacing E6(R2).

ICH E6(R3) Progresses into Step Four

UK

MHRA Updates EHR Remote Access Monitoring Guidance

9/21/2021

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The Medicines and Healthcare products Regulatory Agency (MHRA) of the United Kingdom (UK) updated their guidance document, “Access to Electronic Health Records (EHR) by Sponsor representatives in clinical trials” in September 2021. Originally released in November 2020, it did not provide adequate guidance on direct remote access of EHR. Other relevant guidance only included small sections on remote monitoring, including the March 2020 guidance describing best practices for managing clinical trials during the COVID-19 pandemic and the November 2020 guidance describing how to minimize disruptions in the conduction and integrity of clinical trials amid the ongoing pandemic.

Draft GDPR Adequacy Decision for UK

3/02/2021

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When the Brexit transition period ended at the end of 2020, the United Kingdom (UK) officially left the European Union (EU) single market and customs union. This means that for the purposes of the General Data Protection Regulation (Regulation (EU) 2016/679 or GDPR), the UK is a third country with regards to data transfer. As a third country, personal data transfers require additional safeguards. At the beginning of 2021, the EU-UK Trade and Cooperation Agreement came into effect. A part of this Agreement includes a provision which allows data transfers to continue without additional mechanisms until an adequacy decision is adopted, for a maximum of six months.

How Does Brexit With No Withdrawal Agreement Affect Clinical Trials?

2/26/2019

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The United Kingdom (UK) notified the European Union (EU) of its intent to withdraw effective March 30, 2019, a process commonly known as Brexit. At that point, it will become a “third country” and will not follow the EU regulations for pharmaceuticals. Negotiations are underway for a withdrawal agreement. The European Medicines Agency (EMA) and the European Commission have released guidance related to pharmaceutical companies’ distribution of drugs due to the uncertainty of authorization of a withdrawal agreement.