Getting to grips with serious breach reporting: a new CTR requirement

 A recording of the webinar held Wednesday February 16th, 2022, starting at 1pm GMT, 2 pm CET, 8am EST

The EU Clinical Trial Regulation (CTR) enters force on 31 January 2022.
The CTR requires reporting of certain serious breaches of GCP, protocol and regulation.
New guidance was published in December 2021.
Find out what the requirements are, how and when to report and how the EU CTR requirements differs from the UK requirement.

• What are serious breaches?
• What are suspected serious breaches?
• How and when do they need reporting?
• Do you have a process in place?
• Examples for those that need/do not need reporting.
• What do the words mean: serious, significant degree, reliability and robustness of data?
• What are the “Rights of a subject” that might be affected?

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