Protocol Diagnostic 101: How to Assess your Protocol for Implementation Risks

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.

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