Netherlands

Netherlands

Dutch Trial Register (LTR)

Verified on March 9, 2023

Clinical trials conducted in the Netherlands can be registered on the Dutch Trial Register (LTR) and a results summary must be submitted to the Central Committee on Research Involving Human Subjects (CCMO). These trials shall also be registered in accordance with European Union (EU) regulations, specifically EU Directive 2001/20/EC or Clinical Trial Regulation (EU) No 536/2014 as the Netherlands is a member of the EU.

The LTR includes every piece of information from the former National Trial Register (NTR). On December 15, 2022, the new LTR website became operational. The LTR is managed by the Central Committee on Research Involving Human Subjects (CCMO) and after the LTR is fully operational, the CCMO will submit a new application to the WHO for recognition of the registry.

As of January 31, 2022, a new system called the European Union Clinical Trial Information System (EU CTIS) has been implemented for the registration and reporting of results for clinical trials conducted within the 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
LTR 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
Dutch
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)
LTR Registration

Yes

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 Trials Regulation (EU) No 536/2014.

Registry Updates


  • March 2023: CTIS Newsflash - On March 10, 2023, the latest CTIS Newsflash was made available in the What’s New section by the European Medicines Agency. All updates related to CTIS newsflash can be accessed from the Development of the Clinical Trials Information System page. The information comprises essential data and patterns concerning CTA submissions, CTAs that received a decision, … Continue reading "March 2023: CTIS Newsflash"
  • March 2023: CTIS Newsflash - On March 03, 2023, the latest CTIS Newsflash was made available in the What’s New section by the European Medicines Agency. All updates related to CTIS newsflash can be accessed from the Development of the Clinical Trials Information System page. The information comprises essential data and patterns concerning CTA submissions, CTAs that received a decision, … Continue reading "March 2023: CTIS Newsflash"
  • February 2023: Clinical Trials Highlights - On February 20, 2023, EMA published the thirteenth issue of the Clinical Trials Highlights. All Clinical Trials Highlights updates are posted on the Development of the Clinical Trials Information System page. Starting from January 31, 2023, sponsors are required to submit their initial clinical trial applications through CTIS. EMA has resolved a considerable number of … Continue reading "February 2023: Clinical Trials Highlights"

References