Deviations and Amendments

Deviations and Amendments Workshop July 23, 2008

What's a deviation, anyway? What, exactly, is a protocol deviation, and is it different from a violation? Deviations are defined in the regulations, but violations are not. IRBs have many opinions, FDA has yet another. The IRB Regulations are little help here, so we'll turn to the IRB professional associations to learn their views on definitions, distinctions, and reporting requirements. The FDA Deviations and violations are fundamentally different from amendments. In the first, we document the event after the fact; in the second we obtain permission before the fact. We will use the rules for IDE supplements as a guideline for managing trial deviations and violations. Learning Objective: The goal is to be able to identify a deviation when it occurs, properly categorize it, and determine its reportability to the IRB and FDA. The Workshop: Workshops are informal, interactive, and about 3 hours in length—they are not lectures. Each learner is required to logon individually at their own computer to enhance and track their participation during the event.  The material is presented with PowerPoint slides accompanied by extensive notes and reference material; in fact, each learner has the entire presentation in writing. The presentation is followed by an online quiz to be taken within two weeks. You must participate in the presentation, take the quiz, and provide feedback in order to receive CEUs and a Certificate, but the good news is you will receive CEUs for time spent on the quiz and giving feedback.    More information: Presented by Nancy J Stark, Deviations>>