Essential Guide to the EU Clinical Trial Regulation

Essential Guide to the EU Clinical Trial Regulation

This online, on-demand course covers in more depth the main content and requirements of the EU Clinical Trial Regulation.

The course is interactive and takes around 1-hour to complete. It also contains questions as an integral part of the course to check knowledge gained.

Content includes:

•             Structure of the CTR and supporting guidelines.

•             The Clinical Trial Information System (CTIS) – what is it? Functionality of the CTIS

•             Interventional, non-interventional and low interventional trials.

•             Authorization of a clinical trial – a single application.

•             Notifications and templates.

•             Substantial and non-substantial modifications.

•             Conditions for conducting a clinical trial.

•             Site suitability statement.

•             Additional informed consent requirements.

•             Consent for vulnerable patients.

•             Safety reporting.

•             Serious breach reporting.

•             Urgent safety measures.

•             Summary of trial results.

•             Trial Master File and document retention.

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