The online competency assessment process aims to help non-commercial sponsors of clinical trials who intend to submit ICSRs electronically for the first time to register with the EudraVigilance production environment after one user has successfully completed the assessment.

To be eligible, users must meet all of the following requirements:

• be from a 'new organisation' (non-commercial sponsor of clinical trials);
• be registered in XCOMP with the headquarters of their organisation;
• be from an organisation where no other user who has already completed the face-to-face training or the online competency assessment is registered with EudraVigilance.

Eligible users need to follow a series of steps to complete the online training:

• complete e-learning modules EV-M2, EV-M3a, EV-M3b, EV-M3c, EV-M3d and EV-M3e;
• the organisation and the user should register with the EudraVigilance XCOMP test environment to familiarise themselves with the system functionalities;
• perform the competency assessment by completing some exercises based on ICSR examples provided by EMA and enter them into the EudraVigilance XCOMP environment.

Users have three attempts to pass the assessment. If they fail, they need to take the face-to-face course before they can register with the EudraVigilance production environment.

Successful users will receive an e-mail notification from EMA. They can subsequently train other users within their organisation.

At least one user per organisation must have an email notification of successful completion of the competency assessment before the organisation can initiate electronic submission of ICSRs in the EudraVigilance production environment.

To apply, send a request to: evtraining@ema.europa.eu