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Data Protection for Clinical Trials and Medical Research

Data Protection for Clinical Trials and Medical Research

Booking options

£550

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  • 30 Day Money Back Guarantee
  • Completion Certificate
  • 24/7 Technical Support

Highlights

  • Delivered Online

  • 6 hours

  • All levels

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.

Frequently Asked Questions

  • Is the course interactive?

    Yes, questions and discussion are encouraged throughout the course.

  • How is this course delivered?

    Live online, using Zoom.

  • Why is this course important?

    Clinical trials and medical research are heavily regulated so it is important to handle patient data correctly.  This is particularly important because of the sensitivity of the data and the need to transfer it between different countries.

Dates

  • , to
    Delivered Online
    £550

About The Provider

Computer Law Training is the trading name of Tim Musson.  Since August 2022 he has left Scotland and is now offering his services, all online, from the beautiful island of St Lucia.
Since 2009 when he left his employme...
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