Format

Send to

Choose Destination
See comment in PubMed Commons below
Therapie. 2013 Jul-Aug;68(4):209-23. doi: 10.2515/therapie/2013040. Epub 2013 Aug 28.

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

[Article in English, French]

Author information

1
Université de Lorraine, Nancy, France.

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.

PMID:
23981258
DOI:
10.2515/therapie/2013040
[Indexed for MEDLINE]
Free full text
PubMed Commons home

PubMed Commons

0 comments

    Supplemental Content

    Full text links

    Icon for EDP Sciences
    Loading ...
    Support Center