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International Clinical Trials

Rules and Regulations

This article will focus on electronic data capture (EDC) software services. CROs and sponsors have comprehensive regulatory work ahead in order to comply with the General Data Protection Regulation (GDPR) and need to contract expertise immediately if they do not have it in-house.

In the thousands of ongoing clinical trials in the EU today only a few are in compliance with the GDPR. The EDC systems do not adhere to the new regulations in terms of user authentication and data encryption.

Collecting health information from subjects falls into the ‘special category’ of data defined in the GDPR. In clinical trials, the subject’s physical identities are pseudonymised using a unique identification code, but the data are still considered to be in this ‘special category’ of sensitive information with regard to the GDPR due to the fact that pseudonymised data allow for re-identification. This applies even when the code envelope is locked in a safe with only one person maintaining the key code.

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Christer Nilsson is an entrepreneur and the Chief Executive Officer at Swedish data service provider Trial Online, offering EDC and electronic patient-reported outcome solutions. He has a track record of developing several successful business ventures in the past 20 years.
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Christer Nilsson
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