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.

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.

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

Audience Engagement

Jennifer Lawyer

May 21, 2019

The Importance of Public Speaking in Clinical Research

Jennifer Lawyer

May 21, 2019

5/21/2019

Effective Public speaking is integral to clinical research education/ communication. It impacts every aspect of study conduct.

The investigator educates the study patient on trial participation (via the informed consent) with an avid description of risks, benefits and patient responsibilities
The Clinical Research Associate (CRA) presents protocol procedural information to the study coordinators (SC) at the site initiation visit (SIV) to ensure accurate completion
The clinical trial manager (CTM) trains CRA staff on protocol endpoints to ensure credible data review/collection practices during monitoring visits