Can I read GCP Inspection Guidance for Phase I Units on EtoBox?

GCP Inspection Guidance for Phase I Units by MarcM77 is a document available to read on EtoBox.

What is GCP Inspection Guidance for Phase I Units about?

This document provides guidance for conducting GCP inspections of Phase I clinical trial units. Key areas of focus for inspections include: protocol and dose escalation procedures; ethics committee approval and documents reviewed; quality systems and SOPs; the investigator master file; personnel qualifications and training; emergency facilities and equipment; volunteer screening and care; and investigational product handling and storage. Inspections should ensure Phase I units have appropriate resources, ov

Author

MarcM77

Language

EN