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Knowledge Evaluation

EudraVigilance Courses | Reference DocumentsFAQs 

EudraVigilance Knowledge Evaluation

On the last day of your EudraVigilance training course on Electronic Reporting of ICSRs in the EEA or the Extended EudraVigilance Medicinal Product Dictionary (XEVMPD) training, you are invited to take part in a knowledge evaluation.

Upon successful completion, you receive an email by the European Medicines Agency (EMA) which you have to include to your registration for access to EudraVigilance.

Please note that the password and username that you receive the first day of your training course is valid for approx. 4 weeks and allows access to the EudraVigilance training environment only.

The knowledge evaluation for each training course consists of two sections. A minimum score of 80% is necessary to pass. You have three attempts to pass each section.


EudraVigilance training on Electronic Reporting of ICSRs in the EEA

Section 1 – Multiple Choice
This section consists of 31 randomly selected multiple-choice questions. There is one correct answer for each question. At least 25 questions have to be answered correctly to receive a pass score.

Section 2 – ICSR Exam Case
In this section, you are required to enter data of a mock CIOMS form into the EVWEB tool.

Extended EudraVigilance Medicinal Product Dictionary (XEVMPD) training

Section 1 – Multiple Choice

This section consists of 20 randomly selected multiple-choice questions. There is one correct answer for each question. At least 16 questions have to be answered correctly to receive a pass score.

Section 2: Product Report Exam Case
In this section, you are required to enter data of a mock Product Report Exam case into the EVWEB tool.

Kindly note that the process of evaluating your assessment might take up to several weeks. In case you do not obtain a passing score on your first attempt, the EMA will forward you the link with further instructions for the second and/or third attempt of the section that you did not pass. You will receive an email with your scores by the EMA. The process of evaluating your retake might take up to several weeks.