CTIS & EudraVigilance - Update for Sponsors of Clinical Trials

Recommendation

4-6 June 2024
Munich, Germany

Qualified Person Education Course Module A PLUS IMP Pre-Course Session
Understand the Implications of becoming a QP

The EMA launched the enhanced EudraVigilance system in November 2017 to support the reporting and analysis of suspected adverse reactions (SARs) from clinical trials and the post-approval phase of medicines. Based on a recommendation from the Pharmacovigilance Risk Assessment Committee (PRAC), the mandatory use of the International Standard on "Individual Case Safety Report" (ICSR) revision 3 (ICH-E2B(R3)) for all submissions to EudraVigilance will be implemented starting June 30, 2022. The use of the ICH E2B (R2) format will therefore be phased out (for more information, see Change management for the EudraVigilance system).

Background

The PRAC recommended in October 2019 that the use of the ISO ICSR standard based on the ICH E2B(R3) modalities and the related ISO standard terminology is to become mandatory as of 30 June 2022 as regards reporting obligations to EudraVigilance (pre-and post-authorization). 

A web-based application called EVWEB exists to create and submit the reports. To access EVWEB, it is necessary that at least one employee at the respective company has a certificate, which he receives from EMA after training and knowledge verification. The certificate is necessary to successfully register with EudraVigilance. Obtaining the certificate is part of the trainings offered by EMA.

After the training, users who have to report suspected unexpected serious adverse reactions (SUSARs) originated in the context of clinical trials and sponsors of clinical trials from EVWEB user organizations will be able to apply the ISO / ICH E2B(R3) format and rules to safety reporting based on practical examples for:

• initial SUSARs and follow-up reports;
• amendment and nullification reports;
• parent-child cases;
• reports from interventional studies.

For more information on the training and registration process, please visit EMA´s EudraVigilance training and support website.

CTIS

In addition the updated document "Key Information for Sponsors on CTIS" has been published on EMA´s Clinical Trials Information System website. To get started with CTIS, sponsors must decide their user management approach (depending on how many trials are expected to be conducted) and complete registrations (i.e., in OMS and xEVMPD). Insight into how the Clinical Trials Regulation (CTR) is transforming the clinical-trial environment in the EU / EEA is provided under Clinical Trials Regulation: progress on implementation (e.g., in the document on Key performance indicators (KPIs) to monitor the European clinical trials environment).