August 23, 2017
A protocol deviation is an un-intended departure from the protocol. This webinar is about best practice actions to reduce the number of deviations by analyzing existing deviations. We will discuss how data management can assist in the tracking of deviations to enable teams to focus on determining the root causes. The root cause of most deviations can be narrowed down to one of two issues, complexities with the protocol or a problem at the site. We will discuss how deviations are classified and the differing actions required based on those classifications. We will then take an overarching view and discuss regulatory requirements around deviation ownership, like who should document the finding, who should fix it, and who should track remediation efforts. Finally, we will recommend a five-step methodology that prescribes a how-to approach, including the skills, tools, and techniques necessary for creating best-in-class capabilities.
After attending this Webinar attendees will have an end to end understanding of protocol deviations and a clear methodology to assist them in assuming an integral role in that process.
Debbie has 27 years of industry experience. She has overseen many studies and staff to successfully manage the daily operations of those studies. Debbie also assists study teams by developing and implementing study-specific procedures/instructions, and strategically designing new studies, and monitoring activities. Ms. McGinley is a graduate of Rosemont College.
Participants are eligible to receive CEUs upon attendance and successful completion of a web-based assessment within 30 days after the webinar. CEUs are not granted after the 30-day assesment deadline.
*Please note that a group should be constituted of max. 10 people who will be allowed to take the assessment questions after the webinar. Different members of one group will be able to log in from different regions of the world.