Annex 1 application form: Fill out & sign online

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Click ‘Get Form’ to open the annex 1 form in the editor.
Begin by filling out the 'Trial Identification' section. Enter the Member State, EudraCT number, and full title of the trial. Ensure that you provide a layperson's title for clarity.
In the 'Identification of the Sponsor' section, input all relevant details about your organization and contact person. This includes names, addresses, and contact information.
Proceed to 'Applicant Identification'. Select your role (sponsor, legal representative, etc.) and complete any additional required fields.
For each Investigational Medicinal Product (IMP), provide detailed information in Section D. Include identification, status, and description of each product being tested.
Complete the 'General Information on the Trial' section by detailing objectives, inclusion/exclusion criteria, and endpoints.
Finally, review all sections for accuracy before submitting your completed form through our platform.

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