Clinical trials audit preparation: a guide for good clinical practice (GCP) inspections

This book offers a step-by-step explanation of audit procedures for clinical trials and how a pharmaceutical company should prepare for regulatory audits. The book emphasizes the processes and procedures that should be implemented before a clinical audit occurs. With this book, the reader learns how to organize clinical trial sites from an operational standpoint and how to assist investigators to comply with all regulatory requirements. Coverage looks at audits for the different groups of clinical trials -- clinical investigators, clinicalresearch sponsors, and institutional review boards. The concluding chapter addresses warning letters, common problems / questions, and the issue of fraud and misconduct in clinical research.

• ISBN: 978-0-470-24885-0
• Editorial: John Wiley & Sons
• Encuadernacion: Cartoné
• Páginas: 272
• Fecha Publicación: 09/06/2010
• Nº Volúmenes: 1
• Idioma: Inglés