Implementazione dell'ICM con un approccio basato sul rischio con il CRDe
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Implementazione dell'ICM con un approccio basato sul rischio con il CRDe

Implementazione dell'ICM con un approccio basato sul rischio con il CRDe


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About the Book

Introduzione: con lo sviluppo delle nuove tecnologie, lo sviluppo delle sperimentazioni cliniche (CT) e dei quaderni elettronici di raccolta dati (EDC) si è evoluto. La tradizionale attività di monitoraggio (MT), che prevedeva il controllo del 100% dei dati, è passata al monitoraggio basato sul rischio (RBM) e in particolare al monitoraggio centrale completo (ICM). Obiettivo: implementare l'ICM con il CRDe per un approccio basato sul rischio. Materiali e metodi: sono state selezionate le variabili critiche da monitorare in uno studio clinico. Sono stati sviluppati gli indicatori chiave di rischio (KRI) sulla base delle raccomandazioni dell'agenzia regolatoria. È stato sviluppato un piano MBR. L'ICM è stato condotto in due momenti per misurare i KRI. Il monitoraggio tradizionale è stato confrontato con il monitoraggio centrale completo per gli ICR e per valutare i costi di trasporto, alimentazione e alloggio generati dall'attività di monitoraggio. Risultati: nello studio clinico selezionato sono state scelte 25 variabili critiche da monitorare, come raccomandato dalla letteratura. Con l'ICM, i dati mancanti sono stati ridotti dell'83,03%, quelli errati del 97,36% e quelli incoerenti del 63,54%.


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Product Details
  • ISBN-13: 9786207430635
  • Publisher: KS Omniscriptum Publishing
  • Binding: Paperback
  • Language: Italian
  • Returnable: N
  • Weight: 163 gr
  • ISBN-10: 6207430638
  • Publisher Date: 25 Apr 2024
  • Height: 229 mm
  • No of Pages: 68
  • Spine Width: 4 mm
  • Width: 152 mm


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Implementazione dell'ICM con un approccio basato sul rischio con il CRDe
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