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Legal Minute: Who's REALLY Responsible for a Clinical Trial Congruency review?
Manage episode 407591831 series 3506216
المحتوى المقدم من Darshan Kulkarni. يتم تحميل جميع محتويات البودكاست بما في ذلك الحلقات والرسومات وأوصاف البودكاست وتقديمها مباشرة بواسطة Darshan Kulkarni أو شريك منصة البودكاست الخاص بهم. إذا كنت تعتقد أن شخصًا ما يستخدم عملك المحمي بحقوق الطبع والنشر دون إذنك، فيمكنك اتباع العملية الموضحة هنا https://ar.player.fm/legal.
In this short, we discuss who is responsible for a congruency review in clinical trials. Our guest Istvan Fekete emphasizes that both pharmaceutical companies and research sites share the responsibility for ensuring congruency between the budget, contract, informed consent form (ICF), and coverage analysis. Istvan mentions that a lack of congruency affects both parties and, therefore, both sides should actively participate in the vetting process. While pharmaceutical companies are responsible for ensuring budget and contract congruency, research sites should also conduct thorough reviews to align coverage analysis, budget, and contract. In Istvan’s view, it's not an either-or scenario; both sides play a crucial role in maintaining congruency throughout the clinical trial process.
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