In order to access the CTIS sponsor workspace, a user will need to have an EMA account.

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 section 1.1 of the CTIS Sponsor Handbook of EMA.

Create an EMA account (Self-Register)

There is no approval process for self-registering users. You can access the CTIS landing page immediately after you have received a confirmation email. 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 in CTIS.

For organisations that have no administrator users appointed in IAM (so called CT-centric approach), no roles are required and the user can create a new clinical trial application in CTIS. In that situation, this user will automatically receive a CT administrator role for that clinical trial. More information is provided in section 1.5 of the CTIS Sponsor Handbook of EMA.