Registration CTIS

Users already using other EMA applications (Eudralink, SPOR, IRIS, Eudravigilance, OMS) can use the same EMA account to access CTIS sponsor workspace.

If one does not have an EMA account, one needs to create one by self registration on the EMA Account management page (IAM). The self registration process is described in module 03 of CTIS training material catalogue.

There is no approval process for self-registering users. You can access the CTIS landing page immediately after you have received a confirmation e-mail. It may take up to a working day until your account becomes active.

If you work for a sponsor that has a sponsor administrator user appointed in IAM (so called organisation-centric approach), roles (with permissions) must be given to you by the administrator(s) of this organisation in order to be able to work on CTIS.

For organisations that have no administrator users appointed in IAM (so called CT-centric approach), no roles to sponsor users have to be assigned and the user can create a new clinical trial application (CTA) on CTIS. In that situation, this user will automatically receive a CT administrator role for the clinical trial(s). Still, access will be restricted to the trials created by him/her, regardless if other CTAs have been created by another user using the same organisation.

See further chapter 4 “Management of users and organisations in CTIS” of the CTIS Sponsor Handbook.