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, giving complex international data transfer issues. Also the subjects of the trials are becoming increasingly concerned about what companies do with their personal data. Of course, in addition, clinical trials take place in a heavily regulated context, 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. It also takes into account the relevant requirements of the Clinical Trials Regulation (CTR).
Course content includes:
- 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
- pharmacovigilence
- exemptions permitted by GDPR, specified in the Data Protection Act 2018 and similar legislation
the Data Protection Act 2018- Brexit and current developments in the UK
- Q&A (preferably 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. Although some of the issues do not yet have definitive answers, the course will help you justify your data protection 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 and with other attendees.