Data Protection: Medical Research & Clinical Trials

Data Protection: Medical Research & Clinical Trials

This is a one-day course which covers the data protection issues around conducting clinical trials. This is a highly regulated area, complicated by the international multi-site nature of most trials. There is a great deal of confusion around this and the course clearly explains what you can and can’t do, taking account of the ICO’s and the EDPB’s guidance.

Price for Data Protection: Medical Research & Clinical Trials: £550+VAT

Course dates for 2022:
- Thursday 14th July, 9.30-16.30 - Book&Pay now, or Register Interest

Request a new date. Specify preferred dates in message. No payment required.

This course can be tailored and delivered privately to your team

Request a Quote (please specify preferred dates and expected number of delegates).

Message @Tim directly for more information, or to arrange a meeting to identify your goals.

This is an advanced course, focusing on the implications of data protection legislation for the conduct of medical research and 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.

The course is principally based on UK legislation (UK GDPR and DPA 2018), but also takes account of differences with the EU GDPR.

Issues 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
  • Record keeping for consent
  • Privacy notices for participants
  • Data subject rights in context
  • Processor (vendor) contracts and third party risk management
  • 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
  • Clinical Trials
  • Brexit and current developments in the UK
  • Q&A (preferably dealt with throughout the course)
Delivery: Online (live)
Level: Intermediate
Day & Time:
Week Days
What is included:
Digital courseware
Digital Recording
Printed courseware
Extra revision sessions
Venue: Virtual Live Meeting

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