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FDA Warning Letter to Sponsor – Records, ...

04/22/2025

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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.

FDA Warning Letter to Sponsor – Records, Reports, and Audit Trails
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OGPS and FDA discuss FDA’s Role in the DoH ...

04/08/2025

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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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WMA Adopts 2024 Revision of the Declaration of ...

03/24/2025

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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.

WMA Adopts 2024 Revision of the Declaration of Helsinki
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IRB Warning Letter from BIMO Inspection

03/10/2025

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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.

IRB Warning Letter from BIMO Inspection
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FDA Webinar on Improving the Informed Consent ...

02/26/2025

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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

Privacy Update: FDA Releases Certificates of Confidentiality Guidance

01/26/2021

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The US Food and Drug Administration (FDA) recently released a guidance on Certificates of Confidentiality. The 21st Century Cures Act (Cures Act) amended the privacy protection for study participants’ section relating to Certificates of Confidentiality (CoC). They are now required for any federally funded clinical research that collects or uses identifiable, sensitive personal information, now known as a mandatory CoC. Discretionary CoC may be requested for non-federally funded clinical research, which is the focus of the guidance. The Cures Act also strengthened the protections for CoC by prohibiting disclosure except under specific exceptions.

MHRA Guidance: Building Resilience into Clinical Trials

01/19/2021

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In March 2020, the Medicines and Healthcare Products Regulatory Agency (MHRA) of the United Kingdom released a guidance describing best practices for managing clinical trials during the COVID-19 pandemic. In November 2020, another guidance was issued describing how to minimize disruptions in the conduction and integrity of clinical trials amid the ongoing pandemic. The MHRA published this guidance to help the industry avoid interruptions caused by a persisting health crisis but also to support the applicable use of available flexibilities into routine procedures that better serve trial participants. The MHRA is asking us to build resilience into how we conduct clinical trials. One positive outcome from continuing clinical trials during the pandemic is that it has generated more evidence that remote monitoring using a risk-based approach is feasible and will likely remain a part of clinical trials moving forward.

Now Available for Purchase: Pediatric Clinical Trials Special Considerations

01/12/2021

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Why Take a Course in “Special Consideration in Pediatric Clinical Trials”?

Pediatric clinical trials are important for discovering how the response to investigational products may differ in pediatric populations as compared to adults and are the only way to effectively find new treatments for conditions that exclusively impact children or adolescents. There are many distinctions in how pediatric clinical trials are conducted compared to adult clinical trials, such as understanding differences in children as they mature and how they differ from adults, knowing how to obtain permission and assent to participate from the family, modifying study procedures for a child’s unique needs, understanding barriers to a parent or guardian wanting their child to participate, realizing the differences in regulatory requirements, and more.

Purchase: HERE

How Do You Monitor Sites that Will Not Upload Source to Secure Repositories While Remote Monitoring? – Part 2

01/05/2021

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With no end to site restrictions in sight, sponsor/CRO monitors continue to look for guidance on best practices and logistics for remote monitoring during the pandemic. Our Clinical Leader article “Remote Monitoring In The Wake Of COVID-19 — Practical & Regulatory Considerations” has inspired related questions. Here is a sample of a recent one.

Question: Many sites now use eReg vendors such as Veeva, Florence, RealTime, etc. as a source document depository database for monitors to review and leave source questions within. This allows the monitors to conduct the SDV on certified source remotely.

Part 1 of the blog covered important details about sticky notes being used in monitoring. If you missed it, read more HERE.

What to Do with Unused IP Shipped to Subjects at Home? UPDATE to FDA’s COVID-19 Clinical Trial Guidance on Dec. 4th

12/17/2020

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The Food and Drug Administration (FDA) released an updated COVID-19 clinical trial guidance with clarification on what to do with unused investigational product (IP) shipped to study participants’ homes, a more common occurrence during stay at home orders and quarantines during the pandemic. The new question with answer makes it clear that regulations for IP accountability still need to be followed, but that alternative methods to traditional disposition can be considered.