Guest User
FDA shares FAQs on IRBs

06/17/2025

-

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
Guest User
Final Guidance Released on IRB Written ...

06/03/2025

-

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
Guest User
Now Available: Clinical Pathways’ Major Changes ...

05/30/2025

-

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.

Guest User
FDA Draft Guidance on Considerations for AI Use

05/21/2025

-

In January 2025, the US Food and Drug Administration (FDA) published a draft guidance titled “Considerations for the Use of Artificial Intelligence (AI) to Support Regulatory Decision-Making for Drug and Biological Products” for trial sponsors and stakeholders intending to use AI to generate data and clinical evidence.

FDA Draft Guidance on Considerations for AI Use
Guest User
EMA on the use of Real-World Data/Evidence in ...

04/30/2025

-

In March, 2025, the European Medicines Agency (EMA) released a “Reflection paper on use of real-world data (RWD) in non-interventional studies (NIS) to generate real-world evidence (RWE) for regulatory purposes” as a guidance for stakeholders on quality planning, conduct and analysis of NISs that intend to use RWD to generate RWE.

EMA on the use of Real-World Data/Evidence in Non-Interventional Studies

Sites and Audits

03/08/2015

Laurie Meehan's post to the Quality Systems for Clinical Research Sites LinkedIn group reminds me that it can be confusing for sites how to manage the various types of site audits that occur. Understanding the relationship of an auditor to a research site is so important.