Section A. Trial Identification

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

Section A requires the applicant to provide information which will identify the Clinical Trial.

1. Select the concerned regulatory authority in the Member State (A.1 - Mandatory field).
2. The 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. number, obtained previously through the EudraCT public web site, is added automatically after entry in the Initial Required Information screen (A.2 - Mandatory field).
Note: In the case of a resubmission (see section A.7), this field should contain the same EudraCT number as in the first submission.
3. Click in the free text field and enter the full title of the clinical trial (up to 2000 characters). The title should be identical to the one specified in the study protocol and other documents submitted as part of the Clinical Trial Application dossier (A.3 - Mandatory field).
Note: If this trial is included in more than one agreed PIPAcronym: Paediatric Investigation Plan. Document upon which the development and authorisation of medicinal products for the paediatric population is based. It is presented by an applicant early during the development of a product to the EMA Paediatric Committee in order to agree a paediatric development plan., provide one PIP decision number in field A.8 "EMAAcronym: European Medicines Agency Decision number of Paediatric Investigation Plan" and enter all other PIP decision numbers in field A.3 after the clinical trial title.
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4. Click in the free text field and enter the title of the clinical trial in non-technical terms, suitable for comprehension by individuals without medical/pharmaceutical training, up to 500 characters (A.3.1 - Mandatory field).
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5. Click in the free text field and enter a shortened title of the clinical trial, if one is available (up to 100 characters). This abbreviated title should be identical to the one mentioned in the protocol (A.3.2).
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• Click the button to add text in another language than English.
• Then click to select the language you wish to add content in.
• Click if you add a field in error, or if you wish to delete a previously added language translation.
6. Click in the free text field and enter the sponsor protocol number, which is assigned by the sponsor (up to 35 characters). This should be identical to the protocol number provided when the EudraCT number was obtained and which appears on the receipt of confirmation of the EudraCT number and should remain unchanged throughout the study.The protocol number should not contain any date or blanks and should remain identical throughout the duration of the clinical trial (A.4.1 - Mandatory field).
7. Click in the free text field and enter the sponsor protocol version, which is assigned by the sponsor (up to 10 characters). This should be identical to that appearing in the protocol, though may change according to any updates and amendments to the final protocol. If none is available, please leave blank (A.4.2).
8. Click the calendar to select the date of the protocol in the following format: YYYY-MM-DD. The sponsor protocol date is assigned by the sponsor and should be identical to that appearing in the protocol. Any translation of the protocol should be assigned the same date as in the original document. This date may change according to any updates and amendments to the final protocol. However, the date included in this form should always be the date of the protocol which received the initial authorisation. Any other updates on the protocol date should only be provided in the corresponding significant amendment form when applicable (A.4.3 - Mandatory field).
   Reference: footnote 3 on page 16 of the Commission Guidance on CTAcronym: Clinical Trial - A Clinical Trial Application becomes a Clinical Trial and is searchable within EudraCT once approved. dossier for competent authorities published 30th March 2010).
9. If the trial is registered on the 'Current ControlledIn a controlled Clinical Trial, the tested product is compared to a reference treatment. The reference treatment can be, for example, a placebo, a product known to be effective, a surgical procedure, or a different dose of the same product. Trials' website http://www.controlled-trials.com/isrctn/, please type the International Standard RandomisedA Clinical Trial in which subjects are assigned to one of the treatment arms according to chance. Controlled Trial Number in field A.5.1.
10. If the trial is registered on 'ClinicalTrials.gov', please type the ClinicalTrials.gov identifier (The format for this identifier is “NCT” followed by an 8-digit number, e.g.: NCT00000419) in field A.5.2.
11. If the trial is registered on the WHO Clinical Trials Portal, please enter the WHO International Clinical Trials Registry Platform's (ICTRP) Universal Trial Number (A.5.3).
12. If other identifiers are available click in the left hand field and enter the name of the identifier, then enter the identification number for this trial in the right hand field. Click button to add additional fields and click the button to delete fields added in error (A.5.4).
    Note:
13. By default, this is set to 'No'. Select 'Yes' for any resubmission after the initial application has been withdrawn by the applicant or refused by the competent authority and 'No' for initial application. If this is simply an update of the CTAAcronym: Clinical Trial Application form prior to the final decision on the clinical trial by the competent authority or Ethics Committee the submission number should not be modified. If the application received a negative opinion from the Ethics Committee (or was withdrawn by the applicant from the Ethics Committee) and this is a resubmission to the Ethics Committee then select 'Yes' when completing this form for the Ethics Committee(A.6 - Mandatory field).
    Note:If this is a new CTAAcronym: Clinical Trial Application, the field cannot be altered.
14. Next to 'Indicate the resubmission letter or else select 'First submission', click the drop-down list to select relevant option (A.6).
    Note:For a first submission select 'First submission'.
    If the application is a resubmission, select 'A' for the first resubmission, 'B' for the second resubmission, etc.
15. Select 'Yes' for a trial part of a paediatric investigation plan (PIP) or otherwise, choose 'No'. A paediatric investigation plan is a development plan aimed at ensuring that the necessary data are obtained through studies in children, when it is safe to do so, to support the authorisation of the medicine for children (A.7 - Mandatory field).
    
    Note:For more information, refer to European Medicines Agency Paediatrics guidance pages
16. Enter the European Medicines Agency's decision number for the Paediatric Investigation Plan (PIP) where available. The value entered should have the format: P/xxx/yyyy where 'xxx' is 1,2 or 3 digits and 'yyyy' represents years. The system currently allows entry of only one decision number per clinical trial (A.8 - Conditionally Mandatory - if A.7 is 'Yes', A.8 must be completed.).
17. If this trial is included in more than one agreed PIP, please provide one PIP decision number in field A.8 "EMA Decision number of Paediatric Investigation Plan" and enter all other PIP decision numbers in field A.3 "Full title of the trialThe title as specified in the study protocol and other documents submitted as part of the Clinical Trial Application." after the clinical trial title.
Note: The EMA PIP decision number appears on the title page of the Agency's decision on a PIP in the format P/xxx/yyyy underneath the title "European Medicines Agency decision" (In decisions issued in the old Agency style and format it is printed in the top right corner of the title page.). The EMA PIP decision number is not the same as the EMA PIP procedure number which is formatted EMEA-xxxxxx-PIPxx-yy and which appears on summary reports, opinions, etc.

It is suggested you move to the next section of the Clinical Trial Application ("B. Sponsor Identification")or return to the Clinical Trial Application Menu Overview.