Netherlands

Netherlands

Central Committee on Research Involving Human Subjects (CCMO)

Verified on December 1, 2022

The Netherlands had a primary registry, Netherlands Trial Registry (NTR), with the provision to publish protocol registrations. NTR was a World Health Organization (WHO) recognized primary registry, however, NTR is permanently closed for new study registrations from November 2021 and the recommendation is to register a study in another WHO recognized primary registry. In addition, Central Committee on Research Involving Human Subjects (CCMO) has a requirement to post the results of clinical trials that are conducted in the Netherlands or by a Dutch researcher. It is mandatory to submit the summary results to the CCMO register. From January 31, 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
NTR Additional National Registry/Database (may be mandatory) Sponsor Through a dedicated registration platform (process independent from clinical trial application)

Interventional

(Phase 1-4);

Observational

 English
CCMO Mandatory National Database (includes Ethics Requirement) Sponsor Clinical Trial Application, Through a dedicated registration platform (process independent from clinical trial application)

Interventional

(Phase 1-4);

Observational

 English
Dutch
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)
NTR Registration

No

 Not applicable (NA)
Results

No

 Not applicable (NA)
CCMO Registration

Yes

 Prior to enrollment
Results

Yes

 Within 1 year of the end of trial worldwide
EU PAS Registration

Yes

 Before the start of data collection
Results

Yes

 Within 12 months of the end of data collection

Other Mandatory Requirements

  • A Clinical Trial Application (CTA) is required to be submitted to the national competent authority (NCA) – Central Committee on Research Involving Human Subjects (CCMO) by the sponsor via EudraCT and EU CTIS.
  • Results are required to be posted on EudraCT per European Directive 2001/20/EC and on EU CTIS per Clinical trial regulation (EU) No 536/2014.

Registry Updates

References