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The Who, What, Why, When and How of Protocol Deviations



2017

Overview

A protocol deviation is an unintended 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.

Learning Objectives

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.

Who should attend

This Webinar is intended for beginner and intermediate level data managers who would like to gain a better understanding of the protocol deviation process as well as what they should be doing to assist in that process.

Meet the Instructor

Deborah McGinley, Senior Manager, Data Management

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.

Earn CEUs

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 assessment deadline.
SCDM is authorized by IACET to offer 0.2 CEUs for this program.

Webinar registration

SCDM members: $50
Non-members: $175

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