Impact of a targeted monitoring on data-quality and data-management workload of randomized controlled trials a prospective comparative study

Abstract : Monitoring risk-based approaches in clinical trials are encouraged by regulatory guidance. However, the impact of a targeted source data verification (SDV) on data-management (DM) workload and on final data quality needs to be addressed.
Document type :
Journal articles
Complete list of metadatas

https://hal-univ-rennes1.archives-ouvertes.fr/hal-02280495
Contributor : Laurent Jonchère <>
Submitted on : Friday, September 6, 2019 - 1:43:41 PM
Last modification on : Saturday, September 7, 2019 - 1:26:45 AM

Identifiers

Citation

Claire Fougerou-Leurent, Bruno Laviolle, Christelle Tual, Valérie Visseiche, Aurelie Veislinger, et al.. Impact of a targeted monitoring on data-quality and data-management workload of randomized controlled trials a prospective comparative study. British Journal of Clinical Pharmacology, 2019, ⟨10.1111/bcp.14108⟩. ⟨hal-02280495⟩

Share

Metrics

Record views

5