Netherlands

Netherlands

Central Committee on Research Involving Human Subjects (CCMO)

Verified on January 21, 2022

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


References


  1. 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.