Data carrier (USB key)
Data carrier (CD-rom/DVD)
One paper hardcopy of the CTA and all data + CD ROM or USB flashdrive with all the documents
The relevant Checklist IMP (with or without marketing authorisation in the EEA) shall be completed and attached to the application (available on IMA website in section Clinical Trials > Application).
Related information on CT application procedure is available on the IMA website in section Home > Licences > Clinical Trials > Application.