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Monitoring metrics over time: Why clinical trialists need to systematically collect site performance metrics

BACKGROUND: Over the last decade, there has been an increasing interest in risk-based monitoring (RBM) in clinical trials, resulting in a number of guidelines from regulators and its inclusion in ICH GCP. However, there is a lack of detail on how to approach RBM from a practical perspective, and ins...

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Shranjeno v:
Bibliografske podrobnosti
izdano v:Res Methods Med Health Sci
Main Authors: Yorke-Edwards, Victoria, Diaz-Montana, Carlos, Murray, Macey L, Sydes, Matthew R, Love, Sharon B
Format: Artigo
Jezik:Inglês
Izdano: 2023
Teme:
Online dostop:https://ncbi.nlm.nih.gov/pmc/articles/PMC7615148/
https://ncbi.nlm.nih.gov/pubmed/37795045
https://ncbi.nlm.nih.govhttp://dx.doi.org/10.1177/26320843221147855
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