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As the curtain closed on 2024, FDA issued a new draft guidance to assist clinical trial sponsors, investigators, and institutional review boards (“IRBs”) with defining, identifying, and reporting ...

The U.S. Food and Drug Administration (FDA) published the draft guidance “Protocol Deviations for Clinical Investigations of Drugs, Biological Products, and Devices,” which provides advice for ...

Ethical GmbH, the Swiss company providing personalized software solutions for clinical research committees management, has developed a new software solution designed to simplify the protocol deviation ...

New elluminate platform additions and embedded AI capabilities improve oversight and remove manual work to keep trials on track BOSTON, August 06, 2024--(BUSINESS WIRE)--eClinical Solutions LLC, a ...

As the purpose of a clinical trial is to determine safety and effectiveness of a treatment, it is imperative that the rules of the trial be followed exactly. If there are Instances of "Protocol Not ...

Variables with time-varying effects and the Cox model: Illustration with the role of estrogen receptor status in breast cancer No significant financial relationships to disclose. This is an ASCO ...