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Quality expectations and tolerance limits of trial master files (TMF) – Developing a risk-based approach for quality assessments of TMFs

This article addresses the question of when a trial master file (TMF) can be considered sufficiently accurate and complete: What attributes does the TMF need to have so that a clinical trial can be adequately reconstructed from documented data and procedures? Clinical trial sponsors face significant...

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Uloženo v:
Hlavní autoři: Hecht, Arthur, Busch-Heidger, Barbara, Gertzen, Heiner, Pfister, Heike, Ruhfus, Birgit, Sanden, Per-Holger, Schmidt, Gabriele B.
Médium: Artigo
Jazyk:Alemão
Vydáno: German Medical Science GMS Publishing House 2015-12-01
Edice:GMS German Medical Science
Témata:
trial master file
quality risk management
clinical trial
On-line přístup:http://www.egms.de/static/en/journals/gms/2015-13/000227.shtml
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