CATrialAuthorisation object

Regulatory and ethics bodies involved in approval process

Ethics committee(s)
Agency for data protection

CA - Registration requirements for clinical trials

Registration not mandatory

CA - Submission required to

Submmission not mandatory

Additional Information

Depending if the study includes a supplement and if this supplement is considered as a medicine.

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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