CATrialAuthorisation object

CA - Submission for authorisation mandatory for

Interventional IMP trials
Non-interventional IMP trials

CA - Submission required to

National CA
Other

Additional Information

One single submission to NIPN/ OGYÉI.
The OGYEI will forward one copy of the documentation to the CEC (Central Ethics Committee) for ethical review and opinion.
In case of favourable opinion, NIPN/OGYÉI provides approval.

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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