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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...
| Autores principales: | , , |
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| Formato: | Online Artículo Texto |
| Lenguaje: | English |
| Publicado: |
Elsevier
2021
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| Materias: | |
| 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 |