9 August 2024

EMA/370102/2016

V. 2.4

EudraCT & EU CTR Frequently asked questions

This document provides answers to the most frequently asked questions received on the EudraCT

database and on its public interface, the European Clinical Trial Register (EU CTR).

Clinical Trials Information

possible, since this deadline includes the time necessary for completion of the Member State(s)

procedure, which can take up to 3 months. More information in question

3.

As of 31 January 2023, all initial clinical trial applications in the EU/EEA must be submitted

. The use of the EudraCT database is now limited to

the tasks described in question 2.

With regards to trials for which the Clinical Trial Application (CTA) was submitted to the relevant

The entire process of updating protocol and results information of an EudraCT clinical trial is described

in the EudraCT step-by-step guide. Specific instructions are provided in the User manual. The steps

required to post results are described in the Tutorials on posting results.

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The EudraCT database covers only interventional clinical trials using investigational medicinal

products (IMP):

Regulation 536/2014 are stored in the Clinical Trials Information System (CTIS). CTIS also contains

former EudraCT trials which were transitioned to CTIS: see question 3.

With regards to non-interventional clinical trials, refer to HMA-EMA Catalogue of real-world data (RWD)

Sponsors of EU/EEA EudraCT trials that are expected to continue after 30 January 2025 are required to

active site in the EU/EEA need to be transitioned.

In case a new EU/EEA-country needs to be added to a EudraCT trial, the EudraCT trial needs to

be transitioned to CTIS

first, as this is considered a new trial application for this member state (see

Guidance for the transition of clinical trials).

Trials that are (foreseen to be) completed by 30 January 2025, and that for which no EU/EEA Member

State was added after 30 January 2023, can remain on the EudraCT database, and do not need to be

transitioned to CTIS, see question 10. If an end of trial notification has been submitted in all EU/EEA

member states, but the global end of the trial has not been notified, the trial does not need to be

transitioned: in this case, trial results are expected via EudraCT within 12 months from its global end

The legal basis for the EudraCT database is provided in article 11 of Directive 2001/20/EC.

Two Regulations partially derogate art 11, disclosing data contained in EudraCT to the public and

including data on paediatric subjects:

: legal basis for public disclosure of EudraCT

trials in EU CTR (refer to question 25. )

: legal basis for the inclusion in EudraCT of data

on Paediatric clinical trials authorized only in third countries, and for their public disclosure

(see question

As of January 31

more information, see Clinical Trial Regulation and EudraLex - Volume 10

For trials that were submitted to the relevant NCA before 31 January 2023, the sponsor needs to liaise

with the NCA directly and not with EMA, in order to:

Sponsors who need to transition their trial to CTIS need to follow the instructions provided in

case of a multi-country trial that need to be transitioned to CTIS, sponsors should ensure the

harmonisation of their clinical trial under the Directive through EudraCT, prior to transitioning their trial

to CTIS.

Please find below a collection of resources to assist sponsors throughout this process.

• section 5 of the CTIS sponsor’s handbook

• Guidance for the transition of clinical trials published by the European Commission under EudraLex

• Clinical Trials Information System Webinar: Second Year of Transition (including presentation)

Clinical Trial Applications of trials that are transitioned from EudraCT to CTIS are marked as ‘Trial now

transitioned’ in EudraCT by the relevant National Competent Authority. Results of these

transitioned trials need to be submitted through CTIS and not through EudraCT.

Only the member states where the trial is still active should be transitioned to CTIS. In case a trial is

completed in some countries under the Directive 2001/20, while it is transitioned to CTIS under

Regulation 536/2014 for other countries, its results will be expected on CTIS and not on EudraCT.

However, in case a sponsor wishes to provide results in EudraCT too, this is still technically possible. In

The EudraCT Clinical Trial Application (CTA) form schema (.xsd) is available in the Technical

Information section of the supporting documentation pages of the EudraCT Supporting documents

page.

To change the sponsorship for a trial, there should be an agreement between the former sponsor and

the new sponsor, which will need to be communicated to the National Competent Authority(ies) where

the trial is conducted. If the trial is still ongoing, the sponsor should also submit an updated XML file of

the CTA, as this is a substantial amendment (see question 27. and 36. ).

Examples of substantial amendments are amendments to the protocol such as, a change in the title of

the trial, include additional sites/countries etc. The sponsor has to notify the National Competent

Authority (NCA) of the substantial amendment via the ‘Substantial Amendment Notification Form’

more information on the concept of ‘substantial amendment, refer to CT-1 Guidance .

In addition, sponsors should amend the original XML CTA file and submit it with the substantial

amendment form to the NCA(s) to amend the information in the public domain (EU CTR), see question

17. and 27. . The National Competent Authority(ies) is(are) responsible to amend the system and

upload the amended XML CTA file in EudraCT to supersede the previous information.

For any enquiry on the retrospective registration of a clinical trial, a sponsor needs to liaise directly

with the National Competent Authority(ies) of the Member State(s) where the trial is authorised.

This amendment is considered a ‘substantial amendment’. See questions 17. , 27. and 36.

Although EudraCT supports entries of clinical trial data in any EU language, it is advisable that

sponsors provide the information, such as for the title of the trial, also in English.

to EudraVigilance instead of separately to national competent authorities in each EU / EEA country

countries, sponsors should report SUSARs also to national ethics committees (sponsors are advised to

Product Dictionary ('EVMPD')". Investigational Medicinal Product should be input as a new

Development Medicinal Product in the XEVMPD. Users registered with EudraVigilance should send an

XEVPRM with the operation type 'insert' for a new development product in the XEVMPD.

Providing that the insert was successful, the corresponding EVCODE will be sent automatically to the

sender's organisation ID via XEVPRM acknowledgement. If the sender is a WEB Trader user, the

XEVPRM Acknowledgement will go to the WEB Trader Inbox. Gateway users should check with their

Gateway providers where their XEVPRM Acknowledgements are stored. For information on how to

register with EudraVigilance, see the EudraVigilance registration webpage

. Note that you need to use

revised XML file of the CTA including amended data should be submitted alongside the substantial

amendment form. In this case, A.4.1 & A.4.2 (revised XML CTA form) and B.4 (in the substantial

amendment form) should contain the updated-proposed protocol number and version of the trial. E1

(in the substantial amendment form) should include the sponsor's substantial amendment code

If, when updating section A.8 with the number of the Paediatric Investigation Plan, the following

message is displayed "the value entered should have the format P/xxx/yyyy, where "xxx" is 1, 2 and 3

digits and "yyyy" represents years", the sponsor is advised to delete the first leading zero so that the

PIP decision number complies with the format allowed in EudraCT, i.e.: P/xxx/yyyy.

be in place in order to undertake some or all of the statutory duties of the sponsor in relation to the

trial.

To activate the legal representative section in the system, a country that is not under EU/EEA law

needs to be specified in section B.1.3.4. If the main sponsor of a clinical trial is not based in the

European Economic Area (EEA), the system will allow the sponsor to nominate a legal representative

that is based in the EEA.

Section D

If the new substance is not available through the search functionality in EudraCT (section D “IMP

In order to solve the error “D.2.2.3 The products to be administered as IMPs are defined as belonging

to an ATC group): It is mandatory to identify at least one active substance for every IMP except when

The international and applicable area codes need to be included. A functional email address can also be

through the EMA self-registration form. After this, the sponsor needs to request assignment to be the

primary user for your trial (download and fill in the form, then log in here, click on “your page” and

Yes, they are required. However, they will be visible only to National Competent Authorities, EMA, and

European Commission. Phase 1 trials conducted solely in adults will never be made public, even after

Result-related information for paediatric trials should be posted to EudraCT within 6 months of the end

of the trial. Result-related information for non-paediatric trials included in an agreed PIP should be

posted within 12 months of the end of the trial. This is irrespective of whether the product is

authorised or not. See this document

.

The European Commission has published a guidance which describes the inclusion of clinical trial

results and it is available here: Commission Guideline

on results posting.

In addition, a joint letter has been published on the EudraCT website: Joint Letter by the European

Commission, EMA and HMA.

In case the full data set is required (see question 55. ), no anonymization is possible. In case posting

the summary attachment is sufficient, the Commission Guideline does not refer to anonymization of

the Commercially Confidential Information (CCI) or personal information. In this case, it is the

of the trial. This is irrespective of whether the product is authorised or not. Refer to this link

for

additional information on submitting results of paediatric studies.

In case your trial is transitioned to CTIS under Regulation 536/2014 its results will be expected on

CTIS and not on EudraCT. The same applies when your trial was completed in some countries under

the Directive 2001/20, while it is still ongoing in others and has been transitioned to CTIS, under

instructions. Refer to EMA Account Management webpage for any other issue. Please note that it is no

user manual).

After having logged in EudraCT, the sponsor needs to request assignment to be the primary user for

the trial as described in step 2 of the Tutorials on posting results (download and fill in the form then

log in the EudraCT tools and login page, click on “your page” and “request assignment”, fill in the same

information as per the form and upload the filled in form). The request is then processed by EMA within

a few working days. Once the request is accepted, the sponsor is notified and can then

log in EudraCT

and create the results data module of the trial.

Please note that only 1 primary user can be assigned per trial. Assigned primary users can proceed

with uploading results, as well as with adding other users to their trial as back-up, for results entering

.

• the CTA form was submitted by the sponsor, but not uploaded into the system by the NCA,

We recommend the sponsor to ensure that the CTA package was created

submitted to the NCA(s). The sponsor should liaise directly with the National Competent Authority if

the CTA was submitted to the NCA, but the trial cannot be found in the system. A full overview of

the user manual.

No, this is not needed, see Tutorials on posting results. The ‘activation of results user role’ was an

action that sponsors had to perform before 7 August 2024 and that is now no longer required.

The sponsor should check internally whether a back-up user is assigned for the trial. In case there is a

back-up user, they can remove the primary user directly in the system, and nominate a new one, see

Delegation for results

.

If there is no back-up user, the sponsor needs to contact the EMA Service Now, adding the extension

@id.ema.europa.eu to the EMA username. For non-registered users: create an EMA account. It is

The sponsor needs to notify the National Competent Authority (NCA) of the premature end of the trial

by filling in the End of Trial notification form and asking them to set the trial status as “prematurely

ended”. Results for this trial need to be posted as a pdf document, see question

70.

To know how to post your document, please refer to instructions

. After you have uploaded your

document, please make sure to post it by clicking on “post results” at the top right corner of the

webpage.

No template is present, you can use your company's headed paper and justify why the trial has never

started or has prematurely ended. Any results that are present need to be included in the document.

Timing of results posting and postponement of deadline

In line with the Commission Guideline on results, for trials conducted on adults only, sponsors need to

post results within 12 months from the End of Trial date. For trials conducted also on paediatric

subjects, sponsors need to post results within 6 months from the End of Trial date, in line with

reminder from the EMA, and the proposed deadline for results posting cannot be met, you need to

There may be implications at National level. EMA is not responsible to apply a penalty to sponsors who

are not fulfilling the legal requirements to provide results in EudraCT. All the results for phase I-IV

clinical trials are required to be posted to EudraCT as per the Commission Guideline

provided to the EMA upon receipt of the reminders mentioned in question 73. the EudraCT number of

the trial may be listed in the List of trials for which National Competent Authorities and EMA could not

reach sponsors, or for which sponsors could not follow up on reminders to post results. This list is

first. However, notwithstanding the above, if (a) the clinical trial does not fall within the scope of

Article 46(1) of the Paediatric Regulation, and (b) it is for objective scientific reasons not possible to

submit the result-related information within six months, which has been demonstrated by the

submitting party, result-related information for paediatric trials may be submitted to the EMA, for entry

into EudraCT, at the latest within twelve months after the trial has ended, whether the trial has been

completed or prematurely terminated, whichever occurs first.

This means that an extension to the 6-month rule can be granted only for trials which are not in scope