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Protocol FAQs

1. Can I save an invalid or incomplete clinical trial application or third country clinical trial file?
Yes but only locally and not to the EudraCT system.

 

2. Can I prepare a CTA submission with a clinical trial application that does not meet all of the current business rules as identified in the validation tool?
Yes you can, if you are unable to meet the business rules and you are able to provide an explanation in the covering letter of your submission. However, you should resolve any omissions or conflicts that can be solved.

 

3. I am a third country data provider (PIP addressee, or Article 46 data provider). How do I prepare protocol-related third country information for inclusion in EudraCT?
You can prepare this by logging on to EudraCT public site and creating a new third country file for a trial for which you do not have an XML or by editing an EU XML file that already exists for the same trial. Once you have prepared the XML file you can save it locally on your system.
For inclusion of third country clinical trial information you will need to post the third country file to EudraCT. Unlike EU CTA XML files third country files are not processed by NCAs but are posted by the third country data provider using EudraCT.
In order to post a third country clinical trial file you need a user ID, password and the third country data provider user role. Once you have these credentials you can post the third country trial file by logging on to EudraCT

 

4. I am a third country data provider (PIP addressee, or Article 46 data provider). How do I obtain a user ID and password?
Third country data providers are PIP addressees and Article 46 data providers. Note that all people registered as “person authorised to upload 3rd country clinical trial data to EudraCT” in the respective PIP application can use their Eudralink credentials to access EudraCT. In order to register as a third country data provider, please submit a scanned letter to paediatrics@ema.europa.eu requesting authorisation of a person or a functional mailbox for the upload of third country clinical trial data to EudraCT. This letter should be written on headed paper of the PIP addressee/marketing authorisation holder/sponsor. It should be signed by a representative of the PIP addressee/marketing authorisation holder/sponsor and contain a clear statement that the person (or functional entity) named in the letter is to be given permission to provide clinical trial data to the EudraCT database’).
State the relevant PIP number(s) or alternatively state that you intend to upload Article 46 data, as applicable. The letter should also contain the following elements: name, address, postcode, city, country, e-mail, and optionally telephone, telefax.

 

5. I hold an agreed PIP. When should I submit protocol-related third country trial information?
In accordance with the European Commission a third country file should be submitted no later than one month after, either the EMA decision agreeing a PIP, or the first approval/positive opinion of the trial by a third country competent authority and/or third country ethics committee, whichever is the latest.

 

6. If my third country file previously uploaded requires amendments what should I do?
Go to the EudraCT public site, load and edit your current XML file and upload the revised XML file to EudraCT.

 

7. For which trials am I required to post third country information?
In addition to all interventional clinical trials with at least one investigator site in the EEA the requirements for posting information apply also to interventional clinical trials in scope of Article 46 of Regulation No 1901/2006, and those that are included in an agreed PIP (regardless whether the trial includes paediatric subjects or not), even if conducted outside the EEA.

 

8. If a clinical trial in an agreed PIP or in scope of Article 46 of Regulation (EC) No 1901/2006 comprises sites inside the EEA as well as in third countries do I still need to post third country information?
Yes. If the clinical trial comprises sites inside the EEA as well as in third countries, third country information is to be posted directly to the EudraCT database in addition to the EEA CTA, which is submitted to the NCAs.The same EudraCT number should be used for EEA CTA(s) and the third country file of the same trial.

 

9. I tried to update the EudraCT application in section A.8 with the decision number of the paediatric investigation plan, but I get the message "the value entered should have the format P/xxx/yyyy, where "xxx" is 1, 2 and 3 digits and "yyyy" represents years". What should I do?
We recommend you delete the first leading zero so that the PIP decision number complies with the format allowed in EudraCT, i.e.: P/xxx/yyyy. It is envisaged that the required data format in this field will be updated in the future.

Protocol FAQs continued

 
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