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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
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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

NEW UPDATE to Appendix FAQ: FDA’s COVID-19 Clinical Trial Guidance on May 11th

5/12/2020

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As clinical research professionals proceed to work around COVID-19 restrictions while maintaining GCP, questions continue to arise. On May 11th, the Food and Drug Administration (FDA) released an updated Q&A section of their COVID-19 clinical trial guidance with three additional questions and answers included.

Some questions of note from the last two updates are:

EMA Updates Guidance on Clinical Trials Amid COVID-19 Restrictions

5/05/2020

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As we are settling into the new normal of COVID-19 restrictions, many are still unsure how to proceed to maintain subject safety and data integrity and face decisions on whether to continue clinical trials, suspend them, or even start a new trial. Questions remain about how to securely monitor source data remotely while maintaining data privacy and following regulations, and new issues became evident, such as how subjects could receive investigational product at home. There are many sources of information to guide sites and sponsors/CROs through these challenges.

LSTI Webinar: Remote Monitoring Operations While Maintaining HIPAA and GCP During COVID-19 Restrictions

5/03/2020

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The recent COVID-19 outbreak has disrupted clinical trials drastically. Monitors are grounded but data still needs to be monitored. Despite the FDA, OCR, and EMA guidance, the question remains – how do we do this without putting our monitors or trial subjects at risk while staying compliant?

Webinar Recording: A Case for Sponsor Monitoring Remote Access to a Site’s EMR! Now Available for Purchase

4/30/2020

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Over time, the clinical trial industry has figured out how to coordinate onsite monitoring of a study patient’s electronic health record. This can be through certified copies (very laborious for sites) or increasingly often by providing temporary secure access to source documentation for a particular trial.

Purchase the recorded webinar here. Access to the recording is available for 10 days after purchase.