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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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Automated submissions to Clinical Trials
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国際的な臨床試験情報開示のコンプライアンスに必要な重要な規制知識を一元化した対話型のリポジトリ

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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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