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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New Draft Guidance on Protocol Deviation ...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

telehealth

Is it Really Consent? Considerations in Consenting COVID-19 Patients to Clinical Trials

8/11/2020

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During the pandemic, it has become evident that we must continue to consent COVID-19 patients into clinical trials as we work to discover treatment options and better understand other aspects of the disease. Because of isolation restrictions, it is more cumbersome for all involved to conduct the informed consent process as we are accustomed. The investigator or delegate is likely not permitted into the isolation room to discuss the aspects of the trial with the potential subject. This leads to barriers to their ability to see important facial features communicated during a conversation.

GDPR and Clinical Trials Amid COVID-19

5/26/2020

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The World Health Organization (WHO) is recommending using telehealth during the COVID-19 pandemic. To keep subjects and site personnel safe, many sites have transitioned to using telehealth for study visits. What about safeguarding data and privacy? The General Data Protection Regulation (GDPR) has some stringent rules for collecting or processing data which includes during the conduct of a clinical trial.

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: