Portugal

Portugal

National Registry for Clinical Studies (RNEC)

Verified on June 24, 2022

Portugal has a clinical trials registry, the National Registry for Clinical Studies (RNEC). It is not a World Health Organization (WHO) recognized primary registry. It has provision for posting the protocol registrations for studies conducted in Portugal. Results of the clinical trials conducted in Portugal must be submitted to European Clinical Trials Database (EudraCT). 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
CEIC Mandatory National Database (includes Ethics Requirement) Competent authority Clinical Trial Application

Interventional

(Phase 1-4);

Observational

English
Portuguese
RNEC Mandatory National Database (includes Ethics Requirement) Competent authority Clinical Trial Application

Interventional

(Phase 1-4);

Observational

English
Portuguese
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)
CEIC Registration

Yes

Prospective
Results

n/a

Not applicable (NA)
RNEC Registration

Yes

Prospective
Results

n/a

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