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
- Clinical Trial Application Form. European Clinical Trials Database. https://ec.europa.eu/health/system/files/2019-11/application-form_en_0.pdf. Published November 28, 2019. Accessed January 06, 2022.
- Clinical Trials Regulation. https://www.ema.europa.eu/en/human-regulatory/research-development/clinical-trials/clinical-trials-regulation#transition-period-for-clinical-trial-sponsors-section.
- Clinical Trials Information System: training and support. https://www.ema.europa.eu/en/human-regulatory/research-development/clinical-trials/clinical-trials-information-system-training-support.