Personal data management (GDPR)
Personal data management (GDPR) in clinical trials
The EU's General Data Protection Regulation (GDPR) regulates all personal data management within EU. Regulating how personal data is handled between parties in research projects is an important parameter to ensure the privacy and rights of the research subject in clinical trials.
This is what we can help you with
Clinical Studies Sweden has produced reports and a contract template to support personal data management.
Advisory reports
Clinical Studies Sweden has produced two reports on the interpretation of the GDPR and the processing of personal data when conducting clinical trials.
Personal data responsibility in clinical research
The report ‘Personuppgiftsansvar vid klinisk forskning’ (Personal data responsibility in clinical research) also includes a guide on how to assess personal data responsibility in different research scenarios.
Report: Personuppgiftsansvar vid klinisk forskning (In Swedish) Pdf, 2 MB.
Access to healthcare data for research purposes
The report ‘Åtkomst till hälsodata för forskningsändamål’ (Access to healthcare data for research purposes) describes the legal conditions for the disclosure of personal data from the healthcare sector for clinical research.
Report: Åtkomst till hälsodata för forskningsändamål (In Swedish) Pdf, 658 kB.
Templates
Clinical Studies Sweden has developed a contract template for personal data management under joint personal data responsibility, it's called 'Instructions for the Joint Personal Data Protection Agreement'.
Instruktioner till Avtal för gemensamt personuppgiftsansvar (In Swedish) Pdf, 257 kB.
Contract on joint personal data management in clinical research
The Swedish language version of the template should be used when all parties have their main place of business in Sweden.
The English language version of the template should be used if one or more parties have their main place of business outside Sweden.
Contract on joint personal data responsibility in clinical research (English version) Word, 156 kB.
Our templates are a complement to existing templates for personal data processing in assistance situations, known as PUB contracts, which have been developed by SKR, for example.
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