ECSubmissionOfApplication object

Responsible for study submission

Sponsor

Entitled to study submission

Sponsor
Principal Investigator

Additional Information

The applicant (Sponsor or Coordinator) will be the primary contact person for further communication.

!NB: Specific submission requirements apply to clinical trials involving radiation sources pursuant to Art. 28 KlinV/ClinO:
Additional documents as specified in Annex 3 (5) KlinV/ClinO have to be submitted to the EC by the investigator.
The FOPH shall deliver an opinion on compliance with radiological protection legislation and on the dose estimation which have to be considered by the EC granting authorisation.

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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