Impact of GDPR on clinical trials
The aim of EU General Data Protection Regulation (GDPR), which came into force on 25th May 2018, is to strengthen the protection of personal data across the EU.
Clinical trial data is considered a specific data category, since its processing is necessary for research and scientific purposes.This sensitive personal data includes health, genetic and biometric data, but also racial or ethnic origin, sexual orientation, sex life etc.
The sponsor (data controller) is obliged to inform study participants (data subjects) of GDPR privacy requirements. Data privacy information may be provided as part of the Informed Consent Form, letter to participants, data privacy addendum or in some other format.
Data privacy information should include contact information of the data controller (and the data protection officer), list of all the categories of sensitive personal data that will be collected, explanation of data privacy rights, description of data transfer process and safety measures taken, and retention period information.
During the consenting process the data controller should clearly explain all the rights, rules and risks in relation to the processing of personal data. Consent must be explicit, unambiguous, freely given, but also easy to withdraw. It must be specific to each procedure and used only for those purposes. Although oral consent is sufficient according to GDPR, it is best if the data subject gives a written consent.
GDPR also states that secondary processing of sensitive personal data may still proceed even without the consent of the data subject, but only if it is intended for medical and scientific research purposes that would otherwise be seriously impaired by the consent withdrawal.
Need consulting about GDPR?
Feel free to ask us
Need consulting about GDPR? Feel free to ask us
Lašćinska cesta 40
Planinska ulica 13/2
Office: +385 1 5588 297
Pharmacovigilance: +385 1 5588 297
Clinical trials: +385 1 5614 330
Registration: +385 1 242 0873
Marketing: +385 1 2420 890
Fax: +385 1 2420 860
Tel: +385 1 5588 297
Full company name
Short company name
Marti Farm Ltd. Trade and Services
Marti Farm Ltd.
Lašćinska cesta 40, HR-10000 Zagreb
Planinska ulica 13/2, HR-10000 Zagreb
a limited liability company
Commercial Court of Zagreb
HRK 20,000.00 (paid in its entirety)
Martina Diminić Smetiško, director of the
company (Representing the company
individually and independently, Responsible
person for data protection)
HR3623600001102197724 (Zagrebačka banka)
HR4324020061100628669 (Erste banka)
Full company name: Marti Farm Ltd. Trade and Services
Short company name: Marti Farm Ltd.
Headquarters: Lašćinska cesta 40, HR-10000 Zagreb
Office: Planinska ulica 13/2, HR-10000 Zagreb
Legal form: a limited liability company
Court register: Commercial Court of Zagreb
Registration number: 080751121
Share capital: HRK 20,000.00 (paid in its entirety)
Authorized representative: Martina Diminić Smetiško, director of the company (Representing the company individually and independently, Responsible person for data protection)
Bank account: HR3623600001102197724 (Zagrebačka banka), HR4324020061100628669 (Erste banka)