SSQualityAssurance object

Monitoring

Compulsory

Audit by sponsor

Compulsory

Standard Operating Procedures (SOPs)

Compulsory

Additional Information

Requirements for Quality Assurance/Quality Control, Monitoring and SOPs are as described in EU legislation and guidance and ICH GCP E6.

This project (ECRIN Integrating Activity/ECRIN-IA) has received funding from the European Union’s Seventh Framework Programme for research, technological development and demonstration under grant agreement no 284395
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