Are clinical data from spontaneous pharmacovigilance reports transmitted via the Ministry of Health's web portal sufficient to generate a signal without further documentation?

Author:

Grandvuillemin Aurélie,Jeannot Audrey,Valnet-Rabier Marie-Blanche,Pietri Tessa,Chouchana Laurent,Gautier Sophie,Jonville Bera Annie-Pierre

Funder

Agence Nationale de Sécurité du Médicament et des Produits de Santé

Publisher

Elsevier BV

Subject

Pharmacology (medical)

Reference10 articles.

1. Hypothesis-free signal detection in healthcare databases: finding its value for pharmacovigilance;Bate;Ther Adv Drug Saf,2019

2. VigiGrade: a tool to identify well-documented individual case reports and highlight systematic data quality issues;Bergvall;Drug Saf,2014

3. Causality assessment in pharmacovigilance: the French method and its successive updates;Miremont-Salamé;Therapie,2016

4. Ministère de la Santé et de la Prévention. Première évaluation du portail de signalement des événements sanitaires indésirables. December 2018. https://sante.gouv.fr/soins-et-maladies/signalement-sante-gouv-fr/article/premiere-evaluation-du-portail-de-signalement-des-evenements-sanitaires. [Accessed 27 October 2023].

5. Completeness of spontaneous adverse drug reaction reports sent by general practitioners to a Regional Pharmacovigilance Centre: a descriptive study;Durrieu;Drug Saf,2016

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