Netherlands

Netherlands

Netherlands Trial Registry (NTR)

Verified on September 8, 2021

The Netherlands has a primary registry, Netherlands Trial Registry (NTR), which has a provision to publish protocol registrations. NTR is a World Health Organization (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. Posting protocol registration in NTR is voluntary, whereas, 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

Yes

Prior to enrollment
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


  • September 2021: CTIS Training Update - European Medicines Agency updated the page Clinical trials information system (CTIS): online modular training programme by adding a PDF in Module 19: Quick guide – Introduction: CTIS for SMEs and Academia on September 07, 2021. The document consists of a brief introduction to CTIS and its timeline. It also explains in detail about clinical trial … Continue reading "September 2021: CTIS Training Update"
  • September 2021: CTIS Training Updates - European Medicines Agency updated the page name of Clinical Trials Information System: training programme to Clinical trials information system (CTIS): online modular training programme, on September 03, 2021. The below documents were also updated in CTIS Training Module 03 (User access management) and new versions of documents were added in Module 19 (CTIS for SMEs and … Continue reading "September 2021: CTIS Training Updates"
  • August 2021: CTIS Webinar Update - European Medicines Agency updated the Clinical Trials Information System (CTIS) webinar: How sponsor organisations can prepare for CTIS event page with details pertaining to the webinar that took place on July 29, 2021. It includes the following details provided for easy understanding of the working and functionalities of EU CTIS; Event Summary Documents inclusive of the agenda, … Continue reading "August 2021: CTIS Webinar Update"

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 August 26, 2021.