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Regulatory, Ethical and Patient Engagement Considerations for Plain Language Summaries

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The European Medicines Agency (EMA) and the US Food and Drug Administration differ on their approach to plain language summaries (PLS) of clinical trials.

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Trial participants accessing TrialSummaries.com to learn more information about trials in plain language.
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Professionals accessing TrialScope Disclose to track trial compliancy and awareness of regulations.
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The most widely trusted solution for clinical trial disclosure management
Sponsors accessing TrialScope Intelligence for regulations and requirements.
TrialScope Intelligence
A centralized, interactive repository of the critical regulatory knowledge needed for global clinical trial disclosure compliance

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Considerations for Creating Plain Language Summaries

Writing plain language summaries can be a huge undertaking, especially if translations or a patient review panel are required. See what PLS should include.

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