Scope CTR

Clinical Trial Decision Tool

The Clinical Trial Decision Tool helps you to determine whether your study with a medicinal product 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.

In scope

The new Clinical Trials legislation has taken the legal form of a Regulation (Clinical Trial Regulation (EU) no 536/2014, CTR) and will replace national law. The rules for clinical trial applications, assessments and conduct are identical throughout the European Union (EU). The Regulation applies to all clinical trials (national and multinational) conducted in the European Economic Area (EEA).

There is a specific category called low-intervention clinical trial for which adaptations in the rules for traceability and accountability investigational medicinal product (CTR, article 51.1), monitoring (CTR, article 48),  content of the Trial Master File (CTR, article 57) and damage compensation (CTR, article 76.3) are allowed. See also the document with recommendations of the clinical trial expert group (CTEG) on Risk proportionate approaches in clinical trials. Definitions of clinical study, clinical trial and low-intervention clinical trial are given on this page.

In short, if the medicinal product(s) is/are being investigated and the trial participants are subjected to procedures or are required to follow certain rules of behaviour other than normal clinical practice, it is considered a clinical trial and the CTR is applicable.

Out of scope

The CTR does not apply to non-interventional studies i.e. clinical studies other than a clinical trial. These are studies in which the medicinal product is investigated in normal clinical practice, and in which participants are not subjected to procedures or required to change their behaviour. This means that the treatment, tests and procedures involved do not deviate significantly from normal clinical practice. The following examples are not considered normal clinical practice:

  • administration of a medicinal product without a marketing authorisation in the EEA*,**;
  • administration of a medicinal product in healthy volunteers or in patients without clinical indication or medical need;
  • other unproven interventions as defined in article 37 of the Declaration of Helsinki
  • blinding or randomisation of treatment allocation;
  • additional or more frequent/increased diagnostic or monitoring procedures or sampling performed solely for the purposes of the clinical study;
  • any procedures not considered clinical practice for the individual patient within the framework of the National Healthcare System of the Member State concerned with the clinical study.

*exception is medicinal products where no marketing authorisation is foreseen, e.g. magisterial formulation.

**established off label use of medicinal products with a marketing authorisation is considered normal clinical practice in the Netherlands.

The CTR does also not apply to studies which might involve the administration of a medicinal product, while the object of the investigation is not the administered medicinal product, but exclusively the physiology of the body. For instance, the use of a vasodilator to study how the endothelial function is affected by disease or the use of a challenge agent to study the effect of the challenge.