TY  - BOOK
AU  - Mihajlovic - Madzarevic, Vera
TI  - Clinical Trials Audit Preparation: A Guide for Good Clinical Practice (GCP) Inspections
SN  - 9780470248850
U1  - 615.580724 
PY  - 2010///
CY  - New Jersey
PB  - John and Wiley Sons, Inc.
KW  - Audit Preparation
N1  - The Good Clinical Practice (GCP) audit is a tedious but necessary exercise that assures that all parties do their job properly and in compliance with the applicable FDA code. Clinical Trials Audit Preparation demystifies the audit process for all parties involved, including clinical research sponsors, clinical investigators, and institutional review boards.This book provides a step-by-step explanation of the FDA audit procedures for clinical trials and of how pharmaceutical companies, clinical investigators, and institutional review boards should prepare for regulatory audits. The book emphasizes the processes and procedures that should be implemented before a clinical audit occurs, making this an imperative guide to any professional in the drug manufacturing industry, including drug manufacturing companies, regulatory affairs personnel, clinical investigators, and quality assurance professionals
ER  -