This is an advanced course, focusing on the implications of data protection legislation for the conduct of clinical trials.

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.

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
  • international issues
  • 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 eight and delivery will be through the Google Meet platform.  Attendees will be expected to use a webcam.  Together with Google Meet’s chat facility this will allow interaction with the trainer.