Navigating the Clinical Protocol Activation Process for Industry-Written and Sponsored Clinical Trials. The flowchart and steps below outlines the best practice for processing industry-written and ...

As the curtain closed on 2024, FDA issued a new draft guidance to assist clinical trial sponsors, investigators, and institutional review boards (“IRBs”) with defining, identifying, and ...

The U.S. Food and Drug Administration (FDA) published the draft guidance “Protocol Deviations for Clinical Investigations of Drugs, Biological Products, and Devices,” which provides advice for ...

“The patient sampling size increases, as well, increasing the degrees of freedom within phase 2 and 3 trial parameters that may need to be better controlled and or accounted for in terms of safety, ...

A protocol is the detailed plan of a trial. It outlines how the trial will be run. A group of people who are not involved with the trial should review and approve the protocol. When research teams ask ...