Technical updates

Prerequisites for EudraVigilance registration

Ensure that all users and the sponsor (institution) have an active EMA account created through the EMA Account Management portal.

Check that the sponsor (institution) is registered in SPOR - Organisations Management System. If the sponsor is not registered, the organisation must be registered via the EMA Account Management portal. (see section 3 Organisation information in OMS system in the EudraVigilance registration manual)

A MedDRA license (which is free for non-commercial/non-profit organisations) must be obtained by the sponsor, if not already available. The MedDRA license number is required for the EudraVigilance registration.

EudraVigilance registration

A responsible person (RP) for pharmacovigilance must be registered in EudraVigilance on behalf of the sponsor. The RP should be from the organisation of the sponsor and will have the overall resposibility for EudraVigilance reporting. The RP may have a delegate managing the organisation and its users in the EudraVigilance system. The RP or delegate must have been trained in the EudraVigilance system before access is given, see section 2.4. For sponsors using a CTU for reporting, personel at the CTU must be granted access in EV on behalf of the sponsor by the sponsor’s RP/delegate.

The RP should be registered on behalf of the sponsor in accordance with the EudraVigilance registration manual. In short, the process is as follows:

• RP must log on to the EMA account management portal
• Request access ”EV CS/NCS Responsible” and print page.

The following documents must be submitted via the EMA service desk (see Organization First User QPPV/RP or Change of EU QPPV/RP (europa.eu)). Remember to add "request ID number" (available from the EMA account under "track my requests"). It is recommended that the letter is created directly into the archiving system of the organisation, to ensure retrievable case file and journal entry. Send the cover letter to authorized person, typically research director or dean, along with this procedure for signing before submitting to EMA. RP is typically a CTU leader or similar, while trusted deputy may be a CTU employee.

• Cover letter, confirming that the RP is nominated, include EudraCT number (see example below). The cover letter should be signed by an authorized person (typically research director or dean). If applicable, the cover letter should state the name and position of the previous RP and the name, position and contact details of the new RP as well as confirm that the RP resides within the EU/EEA.
• Include a screenshot of the organisation in SPOR (register here, go to “Search organisation”) or the organisation ID. If the organisation needs to register in SPOR include the printed and signed registration page.
• Form A confirming the delegation of the role as RP, signed by a person with signatory rights for the organisation.
• User declaration, signed by the RP.
• Copy of ID card or driver’s license for the new RP.
• Confirmation of EudraVigilance training (notification of successful completion of both the EudraVigilance ICSR and the XEVMPD knowledge evaluation). Please note, training certificates do not have to be in the name of the new RP, but in the name of any active user of the profile who has completed the relevant courses and is related to the respective organisation.

All forms and detailed requirements to content are available from the RP guideline.

To submit the documents, follow the guidance in Section 4.1 “EU QPPV or Responsible Person access request” in the EudraVigilance registration manual. Make sure to choose “Responsible Person” under EV Environment type in the Service Desk request form.

Registration of RP in the EMA portal

This guidance presupposes that the guidance described in the EMA Registration manual section 4.1 “EU QPPV or Responsible Person access request” has been followed and a request for the RP role has been submitted.

1. Log on with your user in the EMA portal: register.ema.europa.eu
2. Choose ”Manage My Access”:
3. Search for the role “EV HUMAN CS NCS Responsible”:
4. Choose role an click ”next”.
5. Before you can apply for the role, you will be requested to select the organisation you are representing:

• For example: search St. Olav (ORG -100030086 St. Olavs hospital) and confirm with your EMA account user and password.

Save the «Role request ID» that you receive after you have applied and add to the case as requested at the EMA service Desk (See item 1). When it has been added to the original case, you or the person who registered the case will receive an email stating that everything is in order.

If the “EU QPPV/RP” request has not been approved within a few weeks, the request for “EV HUMAN CS NCS Responsible” will automatically be rejected. In this case, the following steps should be followed:

1. Apply for the role “EV HUMAN CS NCS Responsible” (see step 3-5 above)
2. Save the new “Role request ID”
3. Submit the new Request ID in your existing ticket in EMA Service Desk
4. Submit the missing document

The main reason for a request to be rejected is that all required documentation has not been submitted.

When the role is approved, the new RP must log in to the EudraVigilance Restricted Area (production and XCOMP, only Internet Explorer can be used), where the organisation details must be updated by clicking “Manage your profile”. This will ensure that the organisation is activated within the EudraVigilance registration system.

EudraVigilance training

EudraVigilance access can only be obtained after completion of certain training modules and a EudraVigilance ICSR and XEVMPD knowledge evaluation.

Apply for a free non-commercial sponsor training and set-up via: evtraining@ema.europa.eu

The following e-learning modules should be completed:

ema.europa.eu

In order to get access to XCOMP for your organisation, log into EMA Account Management portal and request the XCOMP user role. The QPPV for this organisation will be able to approve your role.

When the training courses have been completed and XCOMP access is obtained, a competency assessment must be done.  Test cases and exercises are provided by EMA for entry into XCOMP. 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. At least one user per organisation has to pass the competency assessment before access to EudraVigilance is granted.

SUSAR reporting in EudraVigilance

The sponsor representative is responsible for forwarding potential SUSARs to the Clinical Trial Unit for data entry into EudraVigilance.

Blinded studies: The RP (or other delegated person) is responsible for breaking the blind for the specific patient prior to reporting the SUSAR to EudraVigilance. Only SUSARs associated with a test IMP or comparator product should be reported to EudraVigilance. SUSARs associated with placebo are usually not submitted (unless the reaction is due to e.g. an excipient or impurity).

The SUSAR must be entered with a correct reference to drug substance and product. The IMP must be registered in the eXtended EudraVigilance Medicinal Product Dictionary (XEVMPD) prior to the first SUSAR submission if not already present. Marketed products will be available in XEVMPD.

Detailed information about how to enter Individual Case Safety Report (ICSR) data in EVWEB is found here:

”EV-M3d EV Reporting process for users: Create and send ICSRs using EVWEB”

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Information about how study specific details are entered in EVWEB is found here:

”EV-M3e Creating and sending ICSRs using EVWEB part II”

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Copies of the SUSAR reports submitted and acknowledgement files from the authorities must be downloaded and stored at a separate restricted access document area for the study until study end. The files are transferred to the project leader for archiving in the Trial Master File at the end of the study (after the database has been locked and the randomisation code has been broken, if applicable).