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Subject: sentinel safety analyses Клиническое исследованиеPhase 1 will include 2 sentinel safety analyses (when the first 40 patients have reached study day 7 [6 days after dosing], then when all phase 1 patients have reached study day 7) during each of which study enrollment will pause for an unblinded IDMC review of all available safety data. Как перевести sentinel safety analyses? Заранее благодарен. |
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Я вот также нашел https://www.healthdatamanagement.com/articles/fda-issues-5-year-plan-to-make-its-sentinel-system-more-robust То есть это система Sentinel? |
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link 8.11.2021 8:16 |
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https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2997302/ Полагаю, здесь набирают небольшую сигнальную / сторожевую когорту, и в ней проводят анализ безопасности |
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