Scarce quality assurance documentation in major clinical trial registries for approved medicines used in post-marketing clinical trials

Scarce quality assurance documentation in major clinical trial registries for approved medicines used in post-marketing clinical trials

Abstract Background This research reviewed major Clinical Trial Registries (CTRs) and assessed the availability of fields on quality assurance for approved medicines used as Investigational Medicinal Products (IMPs) in phase IV clinical trials. Methods Two reviewers independently assessed CTRs of th...

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Bibliographic Details
Main Authors: Yorokpa Joachim Doua, Hanneke Dominicus, Julius Mugwagwa, Suzelle Magalie Gombe, Jude Nwokike
Format: Article
Language:English
Published: BMC 2019-04-01
Series:Trials
Subjects:
Clinical trial
drug registry
investigational medicinal product
drug regulation
product quality
Online Access:http://link.springer.com/article/10.1186/s13063-019-3277-8

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