UA-203495305-1

Clinical Investigator Site Awareness: the EU Clinical Trial Regulation

Clinical Investigator Site Awareness: the EU Clinical Trial Regulation
Product Code: Clinical Investigator Site Awareness: the EU CTR
Availability: In Stock
Price: £50.00

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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.

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