Industry groups are asking the US Food and Drug Administration (FDA) for more clarity about a proposed uniform system for classifying protocol deviations in clinical studies. They say clarification is ...

A protocol deviation or violation is any departure from the study procedures or treatment plans as specified in the IRB-approved protocol. Protocol deviations occur when an investigator does not ...

As the curtain closed on 2024, FDA issued a new draft guidance to assist clinical trial sponsors, investigators, and institutional review boards (“IRBs”) with defining, identifying, and reporting ...

The U.S. Food and Drug Administration (FDA) published the draft guidance “Protocol Deviations for Clinical Investigations of Drugs, Biological Products, and Devices,” which provides advice for ...

Clinical Trial Management Systems (CTMS) were designed to make trial execution inspectable and compliant, and that role remains the backbone of operational control. They are built to log visits, ...