CATrialAuthorisation object

CA - Submission for authorisation mandatory for

Interventional IMP trials
Non-interventional IMP trials

CA - Submission required to

National CA

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.