If you are involved with clinical trials you are inevitably handling large amounts of very sensitive personal data, and, of course, clinical trials are heavily regulated. The data protection issues are complicated by the international nature of this sort of activity.
The course focuses on the requirements of both the EU GDPR and the UK GDPR and the exemptions permitted by them.
Issues covered will include:
- what is a suitable legal basis for processing personal data in clinical trials?
- how does consent (and explicit consent) differ from ‘informed consent (as required by the CTR)?
- record-keeping for consent
- data subject rights
- international transfers – the problem areas and potential technical solutions
- CTR requirements
- exemptions permitted by GDPR, specified in the Data Protection Act 2018 and similar legislation
- Brexit implications
At Computer Law Training we have extensive experience in delivering data protection training at all levels and have worked with clinical trials companies, providing both training and compliance support. Some of the issues do not yet have definitive answers – the course will help you justify your decisions.
Course numbers are limited to 12 and the course is delivered on Zoom. Attendees will be expected to use a webcam. Together with Zoom’s chat facility this will allow interaction with the trainer.
Who is this course for?
This course is suitable for anyone with responsibility for aspects of data protection compliance in an organisation that carries out clinical trials.
A reasonable knowledge of data protection will be assumed.a