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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.

Clinical Trails Day 2018!

5/21/2018

Clinical Trials Day recognizes clinical trials professionals’ contributions to the advancement of medicine and public health. It is celebrated yearly on May 20th globally in remembrance of what is believed to be the first randomized clinical trial. During a time when scurvy killed many at sea, James Lind, the surgeon aboard the HMS Salisbury of Britain’s Royal Navy, devised a “study” involving 12 men given one of six different treatments in May 1747. Those who were given citrus showed improvement. This is regarded as the beginning of clinical trial design.

Future of Clinical Research in Europe Post Brexit

5/20/2018

There are concerns over how the United Kingdom’s (UK) departure from the European Union (EU), also known as Brexit, will affect clinical research stakeholders in the UK and the EU. Brexit will begin March 29, 2019. Since the European Medicines Agency (EMA) is a EU Agency, would that mean that the UK would no longer be a part of the Agency or follow the regulations set by it? What effects would the change have on harmonization of clinical trials through Europe and globally?

How does Brexit affect the EMA headquarters, and will it remain independent?

Additional Delay in Timing of the Compliance to the Updates to the Common Rule. This is Your Opportunity to comment on changes!

4/23/2018

The US Department of Health and Human Services along with 16 other agencies published a Notice of Proposed Rulemaking (NPRM) to delay the compliance date of the updated “Federal Policy for the Protection of Human Subjects,” also known as the “Common Rule,” published in the Federal Register on January 19, 2017. The January 2017 final rule is also known as the “2018 Requirements.”

Sandra SAM Sather Speaking at April 2018 ACRP Conference

4/16/2018

SAM Sather, MS, BSN, CCRC, CCRA, Vice President of Clinical Pathways, LLC, will be speaking at the Association of Clinical Research Professionals (ACRP)’s April 2018 Expo. The session will cover global regulatory issues and counts as 1.0 ACRP continuing education credits.

 

Topic:        “A Global Perspective on Regulations Impacting Clinical Research”

When:        Monday, April 30, 2018 - 3:00 p.m. – 4:00 p.m. EDT

Where:       Gaylord National Resort & Convention Center - National Harbor, Maryland (map)