December 2021: Netherlands Update

New online tool provides insight into the scope of CTR

The CCMO on December 23, 2021, has released an update to provide information about the Clinical Trial Decision Tool which was jointly developed by the Paul Janssen Futurelab and the CCMO.

The new Clinical Trial Decision Tool helps determine whether the drug research falls within the scope of the Clinical Trial Regulation (CTR). The CTR will become applicable in the European Union on January 31, 2022.

After answering a maximum of 13 questions, the Clinical Trial Decision Tool shows whether or not the research falls within the scope of the CTR. The tool also shows whether that is a low-intervention clinical trial. Adapted rules apply to such research.

For more information, follow this link.