For EudraCT studies (drug studies), you must submit a signed copy to the EC of the “Request for authorisation of a clinical trial on a medicinal product for human use to the competent authorities and for opinion of the ethics committees in the community” form. This form is also known as the “annex 1 form – Clinical trial Application Form”.
Registration with EMA and assigning of EudraCT number
This form can only be filled in when the study is registered with the European Medicines Agency (EMA) and an EudraCT-number has been assigned.