This short 20-minute course provides investigators and members of the study team with a heads-up on what clinical trial staff need to know about the CTR.

It highlights what is new and different, and what has changed from the previous EU requirements. Content includes:

• Why the EU introduced the CTR.
• Scope of the CTR.
• New requirements relating to trial conduct.
• New consent requirements.
• Serious breaches and urgent safety measures.
• Changes to safety reporting requirements.
• Pre-trial information requirements.
• Retention of essential documents.
• Risk proportionate approaches to clinical trials.
• Changes for the sponsor.