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RT @onc_ce: 7) Strictly defined, PROs are: “direct reports of patient experience that are usually collected via validated questionnaires wi…
RT @onc_ce: 7) Strictly defined, PROs are: “direct reports of patient experience that are usually collected via validated questionnaires wi…
7) Strictly defined, PROs are: “direct reports of patient experience that are usually collected via validated questionnaires without amendment or interpretation of the patient’s response” See 🔓 https://t.co/FPNxi8EMvv from @HHSGov and @US_FDA.
尺度の内容的妥当性を評価する手続きは,FDAの患者報告アウトカムのガイダンス (https://t.co/d0NhZej6YL)と患者を中心とした医薬品開発のガイダンス (https://t.co/A6VVum5wlW) に準拠。(4/4)