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International Clinical Trials

Reviewing the Rulebook

Most clinical trials companies have gone through detailed exercises to put the data processing into proper framework: carrying inventories, creating the records of personal data processing activities, going through data protection impact assessments, appointing data protection officers, performing training sessions for staff, etc. Companies have been anxious that this could be a big change in clinical trials, as data no longer belongs to those processing it, personal data could be pulled at any time, and any noncompliance will be severely punished.

This article will take one more look at the regulation, revisit more talked about terms, explore potential changes for data management, and see if any rules are in place for electronic data capture (EDC) systems per the new regulation.

About the New Regulation

The EU General Data Protection Regulation (GDPR) 2016/679 became effective in all EU countries (plus Iceland, Liechtenstein, and Norway) as of May 25 2018, repealing the Data Protection Directive (effective since 1995). The main goal of the regulation is to strengthen the protection of an individualís personal data, meaning a person should know what data is being collected about them, for what purpose, and where it is being processed (eg, in case it is transferred outside of the EU). Per the GDPR, any processing of personal data in the context of the activities of a controller or a processor in the EU should be carried out in accordance with this regulation, regardless if the processing takes place in the EU or not. As a maximum punishment for failure to comply, the fines can be as high as EUR Ä20,000,000 or up to 4% of the total worldwide annual turnover of the preceding financial year. Any data breach must be reported within 72 hours upon becoming aware of it, unless it is demonstrably unlikely to cause risks to the rights and freedoms of data subjects (1).

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Kaia Koppel is an Associate Director in the data science and documentation services department at KCR. Gaining her experience in clinical trials, Kaia worked in a top pharmaceutical company in the UK and CROs based in Estonia and Germany. In her current role, she is responsible for assuring full study support, from design and set-up through to conducting the trial until the successful closeout. Kaia is also actively involved in developing data management procedures within the company and supporting other departments in implementing new innovative technological solutions. She also holds a Masterís degree in social sciences.

Agnieszka Felicjanczuk is a Legal Counsel at KCR. Agnieszka has over 10 yearsí experience in legal affairs, providing advice and expertise across much of Europe as well as the US. She has a wealth of experience in contracts negotiation and legal advice provision in clinical trials. In her current role, Agnieszka is responsible for providing legal advice related to business operations of KCR across various jurisdictions, contracts negotiation, and corporate matters. She is actively involved in ensuring GDPR compliance at KCR.
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Kaia Koppel
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Agnieszka Felicjanczuk
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