© European Medicines Agency, 2021

GETTING STARTED WITH CTIS: Reproduction and/or distribution of the content of these training materials for non-commercial or commercial
purposes is authorised, provided the European Medicines Agency is acknowledged as the source of the materials.

Sponsor Quickguide
The European Medicines Agency developed this material to enhance public access to information on the Clinical
Trials Information System (CTIS). The Agency does not warrant or accept any liability in relation to the use (in part or
in whole) or the interpretation of the information contained in this training material by third parties.

As of GoLive on 31st of January 2022, the Clinical Trials Information System (CTIS) becomes the single-entry portal for submitting clinical trials information in the EU,
supporting the day-to-day business processes of authorities and sponsors throughout the life-cycle of a clinical trial.
To get started with CTIS, sponsors must decide their user management approach and complete registrations. A transition period applies for sponsors - Q&A here.

Select your user management approach

The organisation-centric approach The trial-centric approach serves the

serves the needs of organisations Organisation-centric Trial-centric needs of small organisations and
that run multiple clinical trials on a academic sponsors, which may
regular basis. initiate trials on an ad hoc basis.
If you use other
EMA applications
(e.g. Eudralink,
Do you have an EMA SPOR, IRIS, Do you have an EMA
account? EudraVigilance, account?
EudraCT)
Go to EMA Account Go to EMA Account
No Yes you already have Yes No
Management and Register for an EMA Register for an EMA Management and
an EMA Account.
click on "Create a account account click on "Create a new
new EMA account" EMA account"
Have you registered a
Sponsor Administrator?

Log in to SPOR portal No Yes

Can you find your Can you find your
with your EMA account.
organisation in SPOR? organisation in SPOR?

Yes No
If you cannot find No Yes
Register your If you cannot find
your organisation, Register your site(s) in
organisation in your site(s), request
request creation of a OMS
OMS creation of a new one.
new one.
Register your Sponsor
Administrator
Request the first Sponsor Administrator
role for your organisation in EMA Account Have you completed Have you completed the
the CTIS training? Learn more about CTIS training?
Management
product registration
No Yes
here Yes No

Take EMA's online CTIS Take EMA's online CTIS

training Ensure the medicinal training
products related to the
clinical trial are registered in
xEVMPD

READY TO SUBMIT YOUR TRIAL(S)

For more information please consult the CTIS sponsor handbook