Workpackage 3 : Regulatory management and Ethics

 

Objectives 

 

• To complete clinical trial regulatory documentation to ensure adherence to GMP/ GCP and to national and international regulations.

• To manage regulatory and ethical submissions (Competent Authorities, Ethics committee and any other Authorities) and interactions with Competent Authorities and ethics committee throughout the study.

 

CHUM, UVa and ECRIN-ERIC participate to this workpackage.