Blog — Clinical Pathways

April 8, 2025

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OGPS and FDA discuss FDA’s Role in the DoH ...

04/08/2025

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).

March 24, 2025

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WMA Adopts 2024 Revision of the Declaration of ...

03/24/2025

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

March 10, 2025

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IRB Warning Letter from BIMO Inspection

03/10/2025

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.

February 26, 2025

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FDA Webinar on Improving the Informed Consent ...

02/26/2025

On November 8, 2024, the US Food and Drug Administration (FDA) hosted a virtual public webinar for clinical research stakeholders as well as anyone interested in the informed consent process of clinical trials titled “Informed Consent – More than Just Another Document to Sign?”. As the title suggests, the webinar explores the standards for informed consent in FDA regulated trials, how they are impacting the trial participant’s experience, and how they can be innovated and improved upon.

FDA Webinar on Improving the Informed Consent Process

February 19, 2025

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FDA BIMO Inspection Results in Warning Letter

02/19/2025

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

Risk management

Jennifer Lawyer

August 23, 2019

Sandra “SAM” Sather at WCG/MCC Summit Sept. 4-5

Jennifer Lawyer

August 23, 2019

8/23/2019

What: WCG Metrics Champion Consortium (MCC) Summit

Topic: Clinical Trials Risk and Performance Management Summit Agenda

When: September 4 and 5, 2019

Where: The Loews Philadelphia Hotel; Philadelphia, PA

Book the hotel here and ask for the FDAnews rate

Registration is available here.

Jennifer Lawyer

June 11, 2019

ICH Releases E8 “General Considerations for Clinical Trials” Draft Revision for Public Comment

Jennifer Lawyer

June 11, 2019

6/11/2019

Clinical trials have become increasingly complex since the ICH E8 guideline on “General Considerations for Clinical Trials” was finalized in 1997. The draft revision is in Step 2b and available for public comment, and there are some interesting changes to note. Specifically, there is a greater emphasis on patient centricity, design of trials with quality in mind, and risk management. The overlying theme is fit-for-purpose quality as an essential consideration for study design. The revision is part of the Good Clinical Practice (GCP) Renovation initiative. Previously, the ICH E6 GCP R2 addendum was finalized in 2016.