This is an advanced course, focusing on the implications of data protection legislation for the conduct of clinical trials.  It assumes you have significant knowledge of data protection.  If this is not the case, we strongly recommend that you take our Introduction to Data Protection and the GDPR course first.

If you are involved with clinical trials you are inevitably handling large amounts of very sensitive personal data, usually from several countries, and, of course, clinical trials are heavily regulated.  Also the subjects of the trials are becoming increasingly concerned about what is done with their personal data. So data protection compliance is very important.

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)?Clinical Trials
  • record keeping for consent
  • data subject rights
  • international transfers and potential technical solutions to the difficulties
  • CTR requirements
  • the Data Protection Act 2018
  • Brexit

At Computer Law Training we have extensive experience of 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.