Netherlands Clinical Trial Approval Request Form

Conducting clinical trials in the Netherlands requires approval from a recognised Medical Ethics Committee (METC) and compliance with Dutch and EU regulations. This Netherlands Clinical Trial Approval Request Form streamlines the submission process for researchers, pharmaceutical companies and healthcare institutions seeking to initiate clinical research studies.

The form captures essential trial information including study design, investigational products, participant eligibility criteria, and informed consent procedures. It ensures compliance with the Dutch Medical Research Involving Human Subjects Act (WMO), CCMO guidelines, and EU Clinical Trials Regulation requirements.

Paperform makes it easy to collect complex regulatory documentation, coordinate multi-stakeholder reviews, and maintain organised records throughout the approval process. With conditional logic, you can tailor questions based on trial phase, intervention type, and risk classification. Use Stepper to automate follow-up communications with the METC, send reminders for missing documentation, and route approvals through your institutional review board workflow.

Whether you're a principal investigator at an academic medical centre, a clinical research organisation managing multinational trials, or a pharmaceutical company launching new therapeutic studies, this template provides a professional foundation for your Dutch clinical trial applications.