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.
Essential Guide to the EU Clinical Trial Regulation
- Product Code: Essential Guide to the EU Clinical Trial Regulation
- Availability: In Stock
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£100.00