Article ID | Journal | Published Year | Pages | File Type |
---|---|---|---|---|
2578940 | Thérapie | 2013 | 7 Pages |
Abstract
The development of medicinal products is subject to quality standards aimed at guaranteeing that database contents accurately reflect the source documents. Paradoxically, these standards hardly address the quality of the source data itself. The objective of this work was to propose recommendations to improve data quality in three fields (pharmacovigilance, pharmacoepidemiology and clinical studies). The analysis was focused on the data and on the critical stages presenting critical quality problems, for which the current guidelines are insufficiently detailed, unsuitable and/or poorly applied. Finally, recommendations have been proposed, mainly focused on the origin of the data and its transcription.
Related Topics
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Pharmacology, Toxicology and Pharmaceutical Science
Pharmacology, Toxicology and Pharmaceutics (General)
Authors
François Alla, Myriam Rosilio, Christian Funck-Brentano, participants of round table N° 2 of Giens Workshops XXVIII: participants of round table N° 2 of Giens Workshops XXVIII:, Philippe Barthélémy, Sophie Brisset, Dominic Cellier, Olivier Chassany,