Protocols are like one wants to tell someone their baby is ugly.  

But, when sponsors are so closely focused on the protocol, sites bear the brunt of overly complicated and/or unrealistic elements that remain in poorly written (a.k.a. "ugly") protocols. This burden not only leaves a sour taste in your site's mouth but also leaves your study execution and data at risk. Protocol comprehension touches your study from day one and has the power to make or break your study timelines and budgets.

We’ll review tactics and approaches dissecting protocols for clarity, consistency, and true operational feasibility so that sites are able to execute the study - reducing risk, deviations, and amendments.

Participants will join Beth in a critique (“analysis”) of some poorly written protocols (“Protocol Bloopers”) while learning what potential rewrites could look like. We will discuss the effectiveness of proactive approaches and the available tools to mitigate or prevent the compounding effects of having an ugly protocol.

Featured Speakers

Beth Harper

Chief Learning Officer


Beth Harper, Chief Learning Officer at Pro-ficiency, is on a mission to eliminate protocol deviations once and for all. Beth brings 35-plus years of experience in clinical research operations to Pro-ficiency, utilizing this knowledge along with her years of creating live protocol simulation training to create cutting-edge simulation training programs at Pro-ficiency. Beth has published and presented extensively in the areas of study feasibility, site selection, patient recruitment, protocol optimization, sponsor/site relationship management and clinical research professional competencies. Beth received her B. S. in Occupational Therapy from the University of Wisconsin and an M.B.A. from the University of Texas.

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