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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Detalles Bibliográficos
Autores principales: Hecht, Arthur, Busch-Heidger, Barbara, Gertzen, Heiner, Pfister, Heike, Ruhfus, Birgit, Sanden, Per-Holger, Schmidt, Gabriele B.
Formato: Online Artículo Texto
Lenguaje:English
Publicado: German Medical Science GMS Publishing House 2015
Materias:
Article
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4677593/
https://www.ncbi.nlm.nih.gov/pubmed/26693218
http://dx.doi.org/10.3205/000227

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