Q&A with Sarah Andries, Regulatory Affairs Manager at genae
Q: How will the new EU General Data Protection Regulation (GDPR) affect my clinical trial?
A: The General Data Protection Regulation or GDPR is effective as of 25 May 2018 and it will bring substantial changes to the way medical device manufacturers and sponsors will collect and process personal data, including data concerning health.
It is important to understand what personal data means, and what the difference is between anonymous data and pseudonymized data. You have to keep the GDPR in mind, when approaching study staff and patients for participation in your clinical trial.
The rules regarding data transfer and data storage are also more strict, so take into consideration who will have access to your clinical data and to which countries the data will be transferred. Make sure that you have the necessary safeguards in place to provide adequate protection for the data subject and to be compliant with the GDPR.
Discover our other Q&A videos:
• Which country should I go to for my clinical trial?
• Which medical devices fall under the new EU MDR scope?
• Are there any aspects that should be considered during the site selection process which affect the submission?
• Are sites involved in the submission process?
• By when do I need to update the Clinical Evaluation Report?
• Why is it important for manufacturers to focus on the health economics of their device?
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