An applicant is the sponsor’s representative for all communications with the competent authorities/ethics committees.
Applicant for a CTA
An applicant is a person who requests the authorization of a clinical trial, notifies substantial amendments and declares the end of a clinical trial to the competent authorities/ethics committees in the European Union. An applicant represents the sponsor and acts as the contact point for the competent authorities/ethics committees. Applicants are optional, the sponsor or EU legal representative can act as the primary contact should they wish to.
Applicant in the European Union
In the European Union, the applicant is formally identified in the cover letter and in sections C.1/C.2 of the EudraCT form. A letter authorizing the applicant to communicate on behalf of the sponsor is usually included in the Clinical Trial Application. The competent authorities/ethics committees will send all communications to the applicant and will only share information related to the clinical trial if the request comes from the applicant. In some countries, local contacts are involved in addition to the applicant, if the applicant is not based in the concerned country.