Section C. PIP Addressee Identification

Task topic including steps necessary for completing Section C. PIP AddresseeThe PIP Addressee is the legal entity that has received the European Medicines Agency's decision on a Paediatric Investigation Plan (PIP). Identification of a Clinical Trial Application draft.

Complete the email and Eudralink details of the Applicants in C.1 to ensure that PIP Addressees receive a copy of the CTIAcronym: Clinical Trial Information. As distinct from a CTA, CTI refers to Third Country Clinical Trial Information. data as an XMLAcronym: eXtensible Markup Language.

Click button when the sub-section is complete.

Request to receive a copy of the CT Information data as XML

Enter details for section 'C.1 Request to receive a copy of the CTAcronym: Clinical Trial - A Clinical Trial Application becomes a Clinical Trial and is searchable within EudraCT once approved. Information data as XMLAcronym: eXtensible Markup Language' to ensure all concerned parties receive the CTIAcronym: Clinical Trial Information. As distinct from a CTA, CTI refers to Third Country Clinical Trial Information. data XML file.

  1. For C.1.5.1, clickthe relevant radio button to indicate whether 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..
    2. 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.
  2. If you answered 'Yes' to C.1.5.1 then you may provide up to 5 email addresses to which copies of the CTIAcronym: Clinical Trial Information. As distinct from a CTA, CTI refers to Third Country Clinical Trial Information. data XML file will be sent via EudraLink (C.1.5.1.1 - Conditionally mandatory - include at least one email address).
    3. 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.
    Note: Ensure that this field does not contain any spaces within or outside the body of the email address, or rubbish data (e.g. XXXX). Failure to do so, may cause issues with the validity of the XML.
  3. Select 'Yes' if you require secure email delivery of the XML.
    4. 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 button when the sub-section is complete and return to the Clinical Trial Menu.
Once the section is completed to your requirements, progress to the next section ("Section D. IMP Identification") or return to the Clinical Trial Application Menu Overview

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