Improving Risk Assessment in Clinical Trials: Toward a Systematic Risk-Based Monitoring Approach

Regulatory authorities have encouraged the usage of a monitoring (RBM) system in clinical trials before trial initiation for detection of potential risks and inclusion of a mitigation plan in the monitoring strategy. Several RBM tools were developed after the International Council for Harmonization...

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Detalles Bibliográficos
Autores principales: Fneish, Firas, Schaarschmidt, Frank, Fortwengel, Gerhard
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Elsevier 2021
Materias:
Short Communication
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8498219/
https://www.ncbi.nlm.nih.gov/pubmed/34646404
http://dx.doi.org/10.1016/j.curtheres.2021.100643

Internet

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8498219/
https://www.ncbi.nlm.nih.gov/pubmed/34646404
http://dx.doi.org/10.1016/j.curtheres.2021.100643

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