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Legal Minute: Who's REALLY Responsible for a Clinical Trial Congruency review?
Manage episode 407591831 series 3506216
Konten disediakan oleh Darshan Kulkarni. Semua konten podcast termasuk episode, grafik, dan deskripsi podcast diunggah dan disediakan langsung oleh Darshan Kulkarni atau mitra platform podcast mereka. Jika Anda yakin seseorang menggunakan karya berhak cipta Anda tanpa izin, Anda dapat mengikuti proses yang diuraikan di sini https://id.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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