title: How can the quality of medical data in pharmacovigilance, pharmacoepidemiology and clinical studies be guaranteed?
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.
authors: Université de Lorraine, Nancy, France.
authors: François
authors: F
authors: Alla
authors: Myriam
authors: M
authors: Rosilio
authors: Christian
authors: C
authors: Funck-Brentano
authors: Philippe
authors: P
authors: Barthélémy
authors: Sophie
authors: S
authors: Brisset
authors: Dominic
authors: D
authors: Cellier
authors: Olivier
authors: O
authors: Chassany
authors: Jean-Paul
authors: JP
authors: Demarez
authors: Vincent
authors: V
authors: Diebolt
authors: Alain
authors: A
authors: Francillon
authors: Laetitia
authors: L
authors: Gambotti
authors: Hakima
authors: H
authors: Hannachi
authors: Philippe
authors: P
authors: Lechat
authors: François
authors: F
authors: Lemaire
authors: Michel
authors: M
authors: Lièvre
authors: Christophe
authors: C
authors: Misse
authors: Marina
authors: M
authors: Nguon
authors: Antoine
authors: A
authors: Pariente
authors: Michel
authors: M
authors: Rosenheim
authors: Nadine
authors: N
authors: Weisslinger-Darmon
mesh_terms: D016907:Adverse Drug Reaction Reporting Systems / Q000592:standards; D002986:Clinical Trials as Topic; D003625:Data Collection; D016208:Databases, Factual / Q000592:standards*; D006801:Humans; D017891:Pharmacoepidemiology; D060735:Pharmacovigilance; D017410:Practice Guidelines as Topic; D011785:Quality Assurance, Health Care / Q000379:methods* / Q000706:statistics & numerical data; D012107:Research Design / Q000592:standards