Section C. Applicant Identification

Task topic including steps necessary for completing Section C. Applicant Identification of a Clinical Trial Application draft.

Complete the details of the Applicants to both the National Competent Authority (C.1) and the Ethics Committee (C.2).

Click each of the options to open the sections, then click button when the sub-section is complete.

C.1 Request for Authorisation to Competent Authority

Enter details for section C.1 Applicant Identification - Request for the National Competent Authority then click button when the sub-section is complete

  1. Click the drop-down list to choose the relevant option, dependent upon whether the applicant is the sponsor, the legal representative of the sponsor or the individual or organisation appointed by the sponsor to submit the application (C.1., C1.2, C.1.3).
  2. Section C.1.4 concerns the Applicant to the National Competent Authority (NCAAcronym: National Competent Authority) and is the party with whom the NCAAcronym: National Competent Authority will routinely correspond. Enter the details of the legal applicant (who will sign the form).
    Tip: The legal applicant may be the sponsor, the legal representative if the sponsor is established outside the EEAAcronym: European Economic Area. Created in 1994, the EEA combines the countries of the European Union and member countries of EFTA (European Trade Association) Countries that belong to the EEA are: Austria, Belgium, Bulgaria, Czech Republic, Cyprus, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Liechtenstein, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, United Kingdom. Countries that are EEA member countries but NOT part of the European Union are: Norway, Iceland, and Liechtenstein., or an individual or company appointed by the sponsor (or by its legal representative) to submit the application to the NCAAcronym: National Competent Authority. The applicant must be based in the European Union. The NCAAcronym: National Competent Authority Applicant Contact may be a different individual at the same Location/Organisation, if necessary.
  3. In free text field C.1.4.1, enter the full, official name of the Applicant Organisation.
  4. In free text fields C.1.4.2.1- C.1.4.2.3, enter the NCA Applicant Contact (or contact person).
    5. Further Information on Applicant Contact
    The NCAAcronym: National Competent Authority Applicant Contact (or contact person) should be a practical contact and might not be the signatory of the application, but may be the same person as the one mentioned in section B.1.2 if the sponsor is the applicant (or in section B.2.2 if the legal representative is the applicant). The family name, at least, should be provided in C.1.4.2, or be completed with a function (e.g. Head of regulatory affairs). All the fields should be completed even when this repeats the sponsor or legal representative information from B.1 and B.2.
  5. In free text fields C.1.4.3, please provide the full postal address.
  6. For field C.1.4.3.4, click the drop-down list to select the Country in which the applicant organisation is based.
  7. In free text fields C.1.4.4 to C.1.4.5, enter the contact details (phone number, fax). The contact details (phone number, fax,) are those of the National Competent Authority Applicant Contact mentioned in section C.1.4.2.
    8. Note: Please include the international or applicable area codes.
  8. When entering the email address in the free text field please be aware that functional emails are preferred to personal ones.
  9. Click a radio button to indicate if you'd like copy of the CTAAcronym: Clinical Trial Application data saved on EudraCTEudraCT (European Union Drug Regulating Authorities Clinical Trials) is the European Clinical Trials Database of all interventional clinical trials of medicinal products commencing in the European Union from 1 May 2004 onwards. The EudraCT database has been established in accordance with Directive 2001/20/EC. as XMLAcronym: eXtensible Markup Language.
    10. Note: C.1.5.1 is a MANDATORY FIELD and if the answer is 'Yes' then C.1.5.1.1 should contain at least one email address.
  10. If you answered 'Yes' to C.1.5.1 then you may provide up to 5 email addresses to which copies of the CTA XML file (or CTAcronym: Clinical Trial - A Clinical Trial Application becomes a Clinical Trial and is searchable within EudraCT once approved. Information XML, for 3rd Country Applications) will be sent via EudraLink.
    11. Note: These email addresses must have Eudralink accounts for secure password protected delivery unless you answer 'No' to C.1.5.1.2 for delivery without password protection.
  11. Select 'Yes' if you require secure email delivery of the XML.
    12. For Validation Guidance: C.1.5.1.2 is a MANDATORY FIELD: If C.1.5.1 is answered 'No' C.1.5.1.2 answer should also be 'No'. If C.1.5.1 is 'Yes', C.1.5.1.2 may be either 'Yes' or 'No'.C.1.5.1.2. by default is blank.
Click the 'Done' button to return to the C. Applicant Identification section: Done button
C.2 Request for Opinion of the Ethics Committee

Enter details for section C.2 Request for Opinion of the Ethics Committee then click 'Done' button when the sub-section is complete.

This section is not mandatory. It should be completed for applications to ethics committees in those Member States where the Ethics Committee requests this form as part of the application to them. Click 'Done' button when the sub-section is complete.

  1. Click the drop-down list to select relevant type of applicant for an opinion from the Ethics Committee.
  2. In section C.2.5, enter the details of the Applicant to the Ethics Committee, as indicated in step 1, above. This should be the legal Applicant (who will sign the form).
  3. In free text field C.2.5.1, enter the full, official name of the Applicant Organisation.
  4. In free text fields C.2.5.2.1 - C.2.5.2.3, enter the NCAAcronym: National Competent Authority Applicant Contact (or contact person).
    5. Note: The Contact person (C.2.5.2) may be a different individual at the same Location/ Organisation. The Phone, Fax and E-mail should be those of the Contact person.
  5. In free text fields C.2.5.3, please provide the full postal address.
  6. For field C.2.5.3.4, click the drop-down list to select the Country in which the applicant organisation is based.
  7. In free text fields C.2.5.4 to C.2.5.6, enter the contact details (phone number, fax). The contact details (phone number, fax, email) are those of the Applicant Contact mentioned in section C.2.5.2.
    8. Note:. Please include the international or applicable area codes.
Click the 'Done' button to return to the C. Applicant Identification section: Done button
Once the entire section is completed to your requirements, including both sub-sections, you can move to the next section ("Section D. IMP Identification") or return to the Clinical Trial Application Menu Overview

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