Information EU Clinical Trial Regulation available on CCMO's website
On 31 January 2022, the EU Clinical Trial Regulation (CTR) 536/2014 will apply with new rules for research with medicinal products in the European Union. All required information for investigators is available on CCMO’s website in a special section for research with medicinal products in accordance with the CTR.
The CTR replaces the current Clinical Trials Directive 2001/20/EC, which has been embedded in the Dutch Medical Research Involving Human Subjects Act (WMO). In contrast to the Clinical Trials Directive, the CTR stipulates that the procedures for the submission, assessment and conduct of research with medicinal products are the same throughout the EU. A transition period of three years applies.
The section consists of six parts:
- Legal framework CTR
- Clinical trial application (CTR): from start to finish
- Preparation
- Submitting and assessment
- Conduct of study
- End of study
The information is currently only available in English. A Dutch translation will be published on our website as soon as possible.
Partly due to the transition period for the CTR, the page Guide to the review procedure has been revised. Here you can find information on the legal frameworks and procedures for medical research, including research with medicinal products.