SSDataProtection object

Notification to DP Authority/ Ombudsmann is mandatory

No

Approval/ authorisation required

No

Additional Information

The permission to process personal data is regulated in Chapter 1, Section 1(10) Regulation 2009 for clinical trials (en). Accordingly, the Sponsor is responsible for ensuring that the prior approval to process health data is obtained from the regional EC pursuant to Chapter 3 and Section 33 The Health Research Act.
Identifiable personal data may only be transmitted between Norway and a country outside the EEA area if the conditions in Article 45 of the Personal Data Act are fulfilled.

Section 2-5 of the Regulation 2009 for clinical trials (en) covers the protection of physical and mental integrity and personal data as follows:
Pursuant to the regulation, a clinical trial can only be initiated if the trial subject’s right to physical and mental integrity and to a private life are respected and information concerning the trial subject is protected in accordance with the provisions of Personal Data Act (en) and Section 2 (3) of The Health Research Act.

Trial participants’ data are protected by the Norwegian Social Science Data Services

Legal framework (on safeguarding the collection, handling, recording, keeping and/or processing of any clinical trial related data and patient files)

General Data Protection Regulation (GDPR)

National DP act

Lov om behandling av personopplysninger (personopplysningsloven) /
Law on processing of personal data, 15 June 2018 No. 38 („Personal Data Act“)

This project (ECRIN Integrating Activity/ECRIN-IA) has received funding from the European Union’s Seventh Framework Programme for research, technological development and demonstration under grant agreement no 284395
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