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New Final Guidance Q&A on RRAs

07/08/2025

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In June 2025, The US Food and Drug Administration (FDA) released the final guidance titled; “Conducting Remote Regulatory Assessments Questions and Answers” to facilitate understanding about what a remote regulatory assessment (RRA) is expected from establishments when the FDA initiates or requests an RRA.

New Final Guidance Q&A on RRAs
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BIMO Finds Objectionable Conditions During ...

06/23/2025

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On June 5, 2025, the US Food and Drug Administration (FDA) issued a warning letter and FDA Form 483 to an investigator as a result of objectional conditions observed during a Bioresearch Monitoring Program (BIMO) inspection. According to the letter, the investigator did not adhere to the applicable statutory requirements of Title 21 CFR part 312.60 which states: “An investigator is responsible for ensuring that an investigation is conducted according to the signed investigator statement, the investigational plan, and applicable regulations”.

BIMO Finds Objectionable Conditions During Inspection
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FDA shares FAQs on IRBs

06/17/2025

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In February 2025 the US Food and Drug Administration (FDA) posted a series of frequently asked questions (FAQ) on their website from the public regarding Institutional Review Boards (IRB) and the protection of human subjects in research.

FDA shares FAQs on IRBs
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Final Guidance Released on IRB Written ...

06/03/2025

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In February 2025, the US Food and Drug Administration (FDA) and the Department of Health and Human Services (HHS) Office for Human Research Protection (OHRP) released the final guidance “Institutional Review Board (IRB) Written Procedures.”

Final Guidance Released on IRB Written Procedures
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Now Available: Clinical Pathways’ Major Changes ...

05/30/2025

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In the ever changing world of clinical research, staying up to date with the latest guidelines and best practices is crucial. Our Major Changes in GCP from ICH E6(R2) to (R3): Road Map is designed for busy professionals who want to deepen their knowledge on GCP to help ensure they meet the highest standards of quality, safety, and compliance.

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BIMO Finds Objectionable Conditions During Inspection

BIMO Finds Objectionable Conditions During Inspection

06/23/2025

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On June 5, 2025, the US Food and Drug Administration (FDA) issued a warning letter and FDA Form 483 to an investigator as a result of objectional conditions observed during a Bioresearch Monitoring Program (BIMO) inspection. According to the letter, the investigator did not adhere to the applicable statutory requirements of Title 21 CFR part 312.60 which states: “An investigator is responsible for ensuring that an investigation is conducted according to the signed investigator statement, the investigational plan, and applicable regulations”.

Now Available: Clinical Pathways’ Major Changes in GCP from ICH E6(R2) to (R3): Road Map Training!

05/30/2025

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In the ever changing world of clinical research, staying up to date with the latest guidelines and best practices is crucial. Our Major Changes in GCP from ICH E6(R2) to (R3): Road Map is designed for busy professionals who want to deepen their knowledge on GCP to help ensure they meet the highest standards of quality, safety, and compliance.

Now Available: Clinical Pathways’ ICH E6(R3) Good Clinical Practice Training!

05/07/2025

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In the ever changing world of clinical research, staying up to date with the latest guidelines and best practices is crucial. Our ICH E6(R3) Good Clinical Practice Training is designed for busy professionals who want to deepen their knowledge on GCP to help ensure they meet the highest standards of quality, safety, and compliance.

Bye Bye to Five Whys?!

08/16/2022

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Do you ever wonder why people are not doing what you expect? How do you figure out what went wrong and what constraints are getting in the way of everything working as it should? You may have heard that you need to ask the right question, or even about the Five Whys. But if you have used the Five Whys before, have you noticed that you are not confident in the results?

Updated Sponsor CPGM: Focus on Remote Monitoring, CRO Oversight, Electronic Systems

9/28/2021

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The US Food and Drug Administration (FDA) released an updated Compliance Program Guidance Manual (CPGM) for sponsors in September 2021. CPGMs are used to guide FDA inspectors when conducting an inspection for subject protection and data quality and integrity as part of FDA's Bioresearch Monitoring Program (BIMO). Part III, Inspectional, is vastly expanded in line with the current way clinical trials are conducted, including remote monitoring, sponsor’s outsourcing of clinical trial activities, and clinical trials conducted outside the United States. The CPGM increases scrutiny of sponsor processes and procedures related to selection of investigators, electronic systems, and CRO oversight. The following are selected highlights of the changes.