The Netherlands has a primary registry, Netherlands Trial Registry (NTR), which had a provision to publish protocol registrations. NTR is a World Health Organization (WHO) recognized primary registry. 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.
| Registries at a Glance | |||||
| Registry | PHUSE Categorization | Information to be Entered By | Route of Data in Registry | Study Type | Language |
| 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 CTR | EU CTR via Clinical Trial Applications | Competent authority | Clinical Trial Application |
Interventional (Phase 1-4) |
English |
| 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 |
| 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 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) | |
| 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.
- Results are required to be posted on EudraCT per European Directive 2001/20/EC.
Registry Updates
- December 2021: Netherlands Update - New online tool provides insight into the scope of CTR The CCMO on December 23, 2021, has released an update to provide information about the Clinical Trial Decision Tool which was jointly developed by the Paul Janssen Futurelab and the CCMO. The new Clinical Trial Decision Tool helps determine whether the drug research falls within the … Continue reading "December 2021: Netherlands Update"
- December 2021: In Vitro Diagnostic Medical Devices Regulation Update - European Commission provided an update regarding the Progressive roll-out of the In Vitro Diagnostic Medical Devices Regulation on December 20, 2021: The update mentions that the ‘In Vitro Diagnostic (IVD) Medical Devices Regulation’ can now be progressively rolled out, after its adoption by the European Parliament and the Council to ensure there is no shortage … Continue reading "December 2021: In Vitro Diagnostic Medical Devices Regulation Update"
- December 2021: Netherlands Update - Dutch Institutions Finally Make Progress on Clinical Trial Reporting As per the news article posted on TranspariMED on 14-Dec-2021, over 700 clinical trials run by the ten largest Dutch institutions are still missing results, but major institutions are now working to fix the problem, new data suggest. Full results are publicly available on the European … Continue reading "December 2021: Netherlands Update"
References
- Clinical Trial Application Form. European Clinical Trials Database. https://ec.europa.eu/health/sites/health/files/files/eudralex/vol-10/application-form_en.pdf. Published November 28, 2019. Accessed January 06, 2022.