Norway

Norway

No Country Specific Registry

Verified on December 2, 2022

Norway does not have a clinical trials registry of its own. It is an EU/EEA country, it follows EU Directive 2001/20/EC for protocol registration and results posting on EudraCT. EudraCT is a World Health Organization (WHO) recognized primary registry. The clinical trial information posted on EudraCT is available for public view on European Union Clinical Trials Register (EU CTR). From 31 January 2022, European Union Clinical Trial Information System (EU CTIS) has become functional, and Clinical Trials Regulation (Regulation (EU) No 536/2014) is now applicable. EU CTIS will support both protocol registration and results posting activities for clinical trials conducted in EU/EEA.

Registries at a Glance
Registry PHUSE Categorization Information to be Entered By Route of Data in Registry Study Type Language
EU CTIS Not Applicable Competent authority, Sponsor Clinical Trial Application

Interventional

(Phase 1-4)
English
EU CTR EU CTR via Clinical Trial Applications Competent authority Clinical Trial Application

Interventional

(Phase 1-4)
English
REK Mandatory National Database (includes Ethics Requirement) Sponsor Through a dedicated registration platform (process independent from clinical trial application)

Interventional

(Phase 1-4)
Norwegian
EU PAS EU PAS - ENCePP (European Network of Centres for Pharmacoepidemiology and Pharmacovigilance [PASS & PAES requirements]) Sponsor Through a dedicated registration platform (process independent from clinical trial application) Post-authorization Safety Efficacy Studies English
Registration and Results Requirements
Registry Activity Legal Requirement Timing
EU CTIS Registration

Yes

Prior to enrollment
Results

Yes

Intermediate summary of results - within 12 months of the interim data analysis date; Final summary of results and lay person summary - within 12 months from the end of trial in EU/EEA (Non-paediatric Studies); within 6 months from the end of trial in EU/EEA (Paediatric Studies)
EU CTR Registration

Yes

Prior to Enrollment
Results

Yes

Within 12 months of Study Completion (Non-paediatric Studies); Within 6 months of Study Completion (Paediatric Studies)
REK Registration

Yes

Not applicable (NA)
Results

Yes

NA
EU PAS Registration

Yes

Before the start of data collection
Results

Yes

Within 12 months of the end of data collection

Registry Updates


References