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Investigational/study site(s)

  1. Provide the details of the site:

    • Site number

    • Site name

    • Site address

    EUDAMED fields to complete for the national investigational/study site(s)
  2. To add more sites, click Add.

    EUDAMED add button in the national investigational/study site(s)
  3. Provide the details of the investigator:

    • Investigator role

    • Clinical department

    • Investigator details (first name, last name, telephone number and email)

    EUDAMED fields to complete in the investigator information section
  4. To add more investigators you need to have the Site section expanded. Then click Add.

    EUDAMED add button
  5. Provide the Documents related to the investigational/study site:

    • CV of the investigator

    • All information related to the suitability of center including signature

    • All information related to the suitability of center excluding signature *

    • Other national requirements

      EUDAMED files to upload in the documents related to the investigational/study site section

      * For this document you must acknowledge that it does not contain private information, as it is expected to be public. To do it, tick the box.

  6. Select the language(s) in which you will provide the national information from the dropdown list.

    Note

    The system filters the national language(s) of the country of the application.

    EUDAMED select the language(s) in which you will provide the national information field
  7. You can add more languages by clicking Add.

    EUDAMED add button
  8. As soon as a language is defined in the field above, the system will generate the relevant number of dedicated National language-specific information sections:

    EUDAMED national language-specific information link to expand the section