Risk Based Approach実装事例の紹介
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リスクは、システムレベル(SOP、EDC、人員等)及び試験レベル(試験のデザイン、データの収集、同意取得プロセス等)の両レベルで検討する。 試験の成功に悪影響を及ぼす可能性のあるリスク(危険性)は? 「影響(重大性)」「頻度(起こりやすさ)」「検出性(検出のし難さ)」の3つの特性を考慮し、特定したリスクの評価を行う。 リスクの優先度を決める。 それぞれのリスクの優先度は? リスクの優先度に応じて、各リスクを低減すべきか、受容するかを決定する。 低減策はリスクの重要性に見合ったものとし、治験実施計画書デザイン、モニタリング計画、各種SOPやマニュアル、トレーニングに組み込む。 品質マネジメント活動を行い記録する。
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