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Authorise

When the CA authorises an application, the CI/PS is allowed to start.

To authorise an application, follow these steps:

  1. Click Authorise at the top right corner of the page.

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  2. A pop-up will appear.

    Choose if the opinion of the Responsible Ethics Committee is positive or unknown. You can provide comments and add the document for validation.

    EUDAMED fields in the pop-up window to complete and complete action and close buttons

    Note

    The field Responsible Ethics Committee opinion will appear only if the Sponsor has indicated in the application (under National information) that the opinion of the Ethics Committee is unknown. It will not appear if it has been specified that the opinion is positive.

    EUDAMED field responsible ethics committee opinion in the national information tab

    The negative opinion is not an option on the list, because if it is negative, the CI/PS is not allowed to start.

    Important

    It is possible to authorise the application without the opinion of the Ethics Committee. Nonetheless, before the CI/PS starts, the Sponsor must provide the positive opinion of the Ethics Committee.

  3. Once you are done, click Complete action.

  4. The application will change to Authorised.