Data Protection for Clinical Trials and Medical Research

Description

If you are involved with medical research or clinical trials you will need to handle large amounts of very sensitive personal data, and, of course, clinical trials are heavily regulated.  The international nature of this sort of activity gives rise to serious data protection issues.

The course focuses principally on the requirements of both the EU GDPR and the UK GDPR and the exemptions permitted by them.  It also considers requirements arising from the Clinical Trials Regulation.

Topics covered will include:

• brief overview of data protection principles and legal bases
• what is a suitable legal basis for processing personal data in clinical trials?
  • Private vs public sector
• how does consent (and explicit consent) differ from ‘informed consent’ (as required by the CTR)?
  • Confidentiality vs data protection
• record keeping for consent
• privacy notice requirements for participants
• data subject rights in context
• processor (vendor) contracts and third party risk management
• international transfers - the problem areas, legal solutions and potential technical solutions
• CTR requirements
• exemptions permitted by GDPR, specified in the Data Protection Act 2018 and similar legislation across the EU
• the Data Protection Act 2018
• Current developments in the UK and across the EU
• Q&A (normally dealt with throughout the course)

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 make data protection decisions and justify them.

Course numbers are limited to 10 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.