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)

Abstract 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 poten...

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Bibliographic Details
Main Author: Shivam Joshi
Format: Article
Language:English
Published: BMC 2023-01-01
Series:Trials
Subjects:
Online Access:https://doi.org/10.1186/s13063-022-06989-0