New online tool makes CTR scope more transparent
The new Clinical Trial Decision Tool helps you to determine whether your study with a medicinal product falls within the scope of the Clinical Trial Regulation (CTR). The CTR will come into effect in the European Union on 31 January 2022.
After answering 13 questions at most, the Clinical Trial Decision Tool indicates whether or not your study falls within the scope of the CTR. The tool also indicates whether the study is a low-intervention clinical trial. Less stringent rules apply to this type of research. The Clinical Trial Decision Tool has been developed jointly by Paul Janssen Futurelab and CCMO.
The Committee Finder Tool helps you determine which review committee in the Netherlands (accredited MREC or CCMO) should review your study. With the advent of the CTR, a three-year transitional period also comes into effect, during which time you may still submit studies with a medicinal product under the old (current) legislation. This is the reason that the question whether you want to submit your study with a medicinal product under the old (EU Directive 2001/20) or new legislation (CTR 536/2014) has been added to the Committee Finder Tool.