National Clinical Trial Office in the Netherlands

A national clinical trials office (in Dutch: Landelijk Bureau) at CCMO has been set up to validate application dossiers, coordinate and give administrative support in the assessment of multinationals clinical trials by the reviewing medical research ethics committees (MRECs).

The National Clinical Trial Office is responsible for the following tasks:

  • validation of application dossier (complete and within scope of CTR): initial application and substantial modifications
  • selection process reporting Member State (multinational clinical trials)
  • assignment clinical trial to an accredited MREC or CCMO for assessment
  • administrative support in preparing assessment report Part I and communication about assessment with applicant and concerned Member States (multinational clinical trials for which Netherlands is RMS)
  • MS admin CTIS (administrator and support)
  • coordination assessment SUSARs and annual safety reports
  • collect fees and payments to MREC

Specific MRECs are qualified to assess clinical trials in the Netherlands.