How can the quality of medical data in pharmacovigilance, pharmacoepidemiology and clinical studies be guaranteed?

Therapie. 2013 Jul-Aug;68(4):209-23. doi: 10.2515/therapie/2013040. Epub 2013 Aug 28.
[Article in English, French]

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.

Publication types

  • Consensus Development Conference

MeSH terms

  • Adverse Drug Reaction Reporting Systems / standards
  • Clinical Trials as Topic*
  • Data Collection
  • Databases, Factual / standards*
  • Humans
  • Pharmacoepidemiology*
  • Pharmacovigilance*
  • Practice Guidelines as Topic
  • Quality Assurance, Health Care / methods*
  • Quality Assurance, Health Care / statistics & numerical data
  • Research Design / standards