Clinical Trials Audit Preparation: A Guide for Good Clinical Practice (GCP) Inspections

Mihajlovic-Madzarevic, Vera

Ouvrage indisponible

Éditeur
Wiley-Blackwell
Pages
246
Parution
juin 2010
Format
Cartonné
Langue
Anglais
Dimensions
239 × 166 × 21 cm
EAN
9780470248850
  • Résumé

All clinical investigators, sponsors, and Institutional Review Boards have to comply with the applicable FDA code(s). Good Clinical Practice (GCP) Audit Preparation provides a step-by-step explanation of the FDA audit procedures for clinical trials and how a pharmaceutical company should prepare for regulatory audits.
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