Course description
Data Protection: Medical Research & Clinical Trials (Live, Online)
If you are involved with medical research or clinical trials you are inevitably handling large amounts of very sensitive personal data, and, of course, clinical trials are heavily regulated. The data protection issues are complicated by the international nature of this sort of activity.
The course focuses on the requirements of both the EU GDPR and the UK GDPR and the exemptions permitted by them.
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 vs data protection
- 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
- the Data Protection Act 2018
- Brexit and 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 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.
This course can also be customised and offered 'in-house'. For example, you may wish to include a consideration of HIPAA if you are concerned about compliance in the USA or you may need to include some basic data protection background. This is likely to be a cost-effective option if you have several potential attendees - please get in touch to discuss cost and dates.
*We often find that what people really want is not the course but some online consultancy to resolve issues they have. If this is of interest please get in touch.*
Upcoming start dates
Suitability - Who should attend?
This course is suitable for anyone with responsibility for aspects of data protection compliance in an organisation which carries out clinical trials or medical research.
A reasonable knowledge of data protection will be assumed.