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 Trials Regulation (EU) No 536/2014.
Registry Updates
- November 2022: What’s New on EudraCT - European Medicines Agency updated the EudraCT homepage by providing the following update over the What’s New section on November 14, 2022: There are issues reported by the users with uploading clinical trial application (CTA) XML files on EudraCT. This issue is caused by a SPOR malfunction impacting EudraCT and CTIS. As of November 21, 2022, … Continue reading "November 2022: What’s New on EudraCT"
- October 2022: CTIS Training Update - European Medicines Agency updated the page Clinical Trials Information System (CTIS): online modular training program on October 28, 2022, by adding new versions for the below documents in Module 13 – Clinical study reports submissions: Quick guide: Clinical Study Reports submission (v1.1): Updated by providing information on the process to request the Marketing Authorisation Holder (MAH) … Continue reading "October 2022: CTIS Training Update"
- October 2022: CTIS Update - European Medicines Agency updated the event page Clinical Trials Information System (CTIS) bitesize talk: Notifications – Part 1 over the What’s New Section on October 26, 2022: The video recording of the CTIS bitesize talk held on September 28, 2022, is now available on the event page. This bitesize talk provided an opportunity for sponsors … Continue reading "October 2022: CTIS Update"
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.