Managing and reporting serious breaches of the EU Clinical Trial Regulation

Managing and reporting serious breaches of the EU Clinical Trial Regulation

The EU Clinical Trial Regulation 2014 No. 536, as well as national regulations in other countries such as the UK, require that sponsors of clinical trials identify, manage and report certain serious breaches of the trial protocol, GCP and the Regulation.

Now that the EU regulation is in force it is vital that everyone is aware of the fast and rigorous reporting requirement in order to comply with law and avoid inspection findings.

This 45 min online course summarises the requirements and content of the European Medicines Agency 2022 guideline relating to the management and reporting of serious breaches.

It has both narrated and read-only tracks and addresses participants by their first name.

This training is suitable for all those involved in clinical trials in humans, including both sponsors and investigator site personnel, whether based in Europe or elsewhere.

The training can be fully managed by Brookwood (registration, tracking, reporting, certification) or the course can be supplied under license to run on a clients own learning management system.

In addition to the training, each participant has access to a bookshelf of useful resources relating to serious breaches.

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