ECSubmissionOfApplication object
Responsible for study submission
Sponsor
Legal representative domiciled in the EU/EEA
Guidance on study submission available
Yes
Guidance on study submission
The procedure for the submission and the content of the application dossier („research file“) are provided on the CCMO website in section: Home>Investigators >Primary submission or Home>Investigators >Standard Research file
National legal framework in place
Yes
Applicable national legal framework/ Reference
The requirements of the standard research file are based on WMO (en) and the Regulation for scientific research with medicinal products.
Additional Information
The research declaration(s) of participating centres shall be obtained by the sponsor and submitted within 14 days of the initial submission of the research file.
Radiation/Radiotherapy/antibiotics: Most METC/MREC will require a signed statement approving the study from the concerned hospital department.
