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Common Clinical Trial Amendments, why they are submitted and how they can be avoided: a mixed methods study on NHS UK Sponsored Research (Amendments Assemble)

BACKGROUND: Amendments are changes made to a clinical trial after it has received regulatory approval. An amendment can take a significant amount of time and resources to develop, review and implement at participating sites. This can affect the efficient delivery of clinical trials and potentially c...

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Detalles Bibliográficos
Autor principal: Joshi, Shivam
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BioMed Central 2023
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9811046/
https://www.ncbi.nlm.nih.gov/pubmed/36600286
http://dx.doi.org/10.1186/s13063-022-06989-0