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
- August 2022: CTIS Update - The below update was posted on the What’s New Section of European Medicines Agency’s event page Clinical Trials Information System (CTIS): Walk-in clinic on August 03, 2022: The date for the walk-in clinic is rescheduled from August 22, 2022 to August 31, 2022 due to technical issues. Walk-in clinics provide a platform for sponsors to … Continue reading "August 2022: CTIS Update"
- August 2022: CTIS Update - European Medicines Agency updated the event page Clinical Trials Information System (CTIS) bitesize talk: Transitional trials and additional Member State concerned (MSC) application over the What’s New Section on August 02, 2022, with the below update: The video recording of the CTIS bitesize talk held on June 23, 2022, is now available on the event … Continue reading "August 2022: CTIS Update"
- July 2022: What’s New on EudraCT - European Medicines Agency (EMA) updated the EudraCT homepage by providing the following update over the What’s New section on July 29, 2022: There are a considerable amount of clinical trials that are currently marked as ‘ongoing’ in the EudraCT database. In view of the upcoming transition to CTIS, sponsors are encouraged to verify the overall … Continue reading "July 2022: What’s New on EudraCT"
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.