How to set up EudraVigilance access as a small EU clinical trial sponsor

A US-based biotech has just received approval for their first EU clinical trial under the EU Clinical Trials Regulation 536/2014. They have a protocol, an investigator, and a Phase 1 site in Germany ready to screen patients. What they do not have — and have not thought about — is EudraVigilance access. Without it, they cannot submit SUSAR reports as required by EU CTR Article 42. First patient in is six weeks away.

What EudraVigilance is and why you need it

EudraVigilance is the European database for adverse drug reaction reports, managed by EMA. Under EU CTR 536/2014, sponsors must submit SUSARs electronically via EudraVigilance for all clinical trials conducted in EU/EEA Member States. This replaced the previous system where sponsors submitted to each national competent authority separately.

For SUSAR submission from clinical trials, EMA uses the EudraVigilance Clinical Trials Module (EVCTM). Access is managed through the EMA Human Medicinal Products portal, and registration requires a valid EMA account, a legal entity identifier, and completion of EMA's EVCTM registration process.

The registration process step by step

Step 1: Register for an EMA account at the EMA Business Registration system (SPOR — Substance, Product, Organisation and Referential data management). You register your organisation as a sponsor and obtain an Organisation Management Service (OMS) identifier. This takes 2-4 weeks if the application is complete.

Step 2: Register for EudraVigilance access. Log in to the EMA EVWEB system using your EMA account and apply for access to EVCTM as a clinical trial sponsor. You will need to specify the clinical trial(s) you will be submitting for.

Step 3: Complete EMA's ICSR reporting training. EMA requires that users submitting ICSRs complete training on E2B(R3) data standards and EVCTM submission. Training is available via EMA's online portal.

Step 4: Submit a test ICSR. Before live submission access is granted, EMA requires successful completion of test submissions. This tests your technical capability to format and transmit E2B(R3) compliant ICSR data.

Technical submission options

Small sponsors typically use EVWEB — EMA's web-based interface — for manual case entry and submission. This is adequate for low-volume sponsors (fewer than 50 cases per year). Larger volume or multi-product sponsors may use an E2B(R3) gateway — a direct system-to-system connection between a safety database (Argus, ARISg, Oracle AERS) and EudraVigilance.

If you are using a CRO for ICSR processing, verify that the CRO is registered with EVCTM under your sponsor organisation. The submission must be made under your registration, not the CRO's, as the regulatory obligation belongs to the sponsor.

Nimble PV manages EudraVigilance registration and SUSAR submissions for EU clinical trial sponsors. If your first patient in is approaching, talk to Vera at nimblepv.com.