CASubmissionOfApplication object

Responsible for study submission

Sponsor

Guidance on submission of application

• Guidance on clinical trial submission procedure available on OGYÉI website in section: Authorisation > Clinical trials > Clinical Trial Submission procedure.

• Non-commercial trials with IMPs: a simplified protocol should be submitted, containing minimally the justification of the trial, the number of subjects to be engaged, the proposed time of the trial and its recruitment methods (pursuant to 15 Decree No 35/2005).
Detailed info available on OGYÉI website in section: Authorisation- Clinical trials -Non-commercial clinical trials)

• Non-interventional trials with IMPs: Submission procedure provided on OGYÉI website in section: Authorisation of non-interventional studies

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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