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Implementing monitoring triggers and matching of triggered and control sites in the TEMPER study: a description and evaluation of a triggered monitoring management system

BACKGROUND: Triggered monitoring in clinical trials is a risk-based monitoring approach where triggers (centrally monitored, predefined key risk and performance indicators) drive the extent, timing, and frequency of monitoring visits. The TEMPER study used a prospective, matched-pair design to evalu...

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Detalles Bibliográficos
Autores principales: Diaz-Montana, Carlos, Cragg, William J., Choudhury, Rahela, Joffe, Nicola, Sydes, Matthew R., Stenning, Sally P.
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BioMed Central 2019
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6471958/
https://www.ncbi.nlm.nih.gov/pubmed/30995932
http://dx.doi.org/10.1186/s13063-019-3301-z