کد مقاله کد نشریه سال انتشار مقاله انگلیسی نسخه تمام متن
2578940 1130021 2013 7 صفحه PDF دانلود رایگان
عنوان انگلیسی مقاله ISI
How can the Quality of Medical Data in Pharmacovigilance, Pharmacoepidemiology and Clinical Studies be Guaranteed?
موضوعات مرتبط
علوم پزشکی و سلامت داروسازی، سم شناسی و علوم دارویی فارماکولوژی، سم شناسی و اقلام دارویی (عمومی)
پیش نمایش صفحه اول مقاله
How can the Quality of Medical Data in Pharmacovigilance, Pharmacoepidemiology and Clinical Studies be Guaranteed?
چکیده انگلیسی
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.
ناشر
Database: Elsevier - ScienceDirect (ساینس دایرکت)
Journal: Thérapie - Volume 68, Issue 4, July–August 2013, Pages 217-223
نویسندگان
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