Low-Intervention Clinical Trial

EU: Clinical Trials Regulation – ‘Low-intervention clinical trial’ means a clinical trial which fulfils all of the following conditions:

  1. the investigational medicinal products, excluding placebos, are authorised;
  2. according to the protocol of the clinical trial,
    • (i) the investigational medicinal products are used in accordance with the terms of the marketing authorisa­tion; or
    • (ii) the use of the investigational medicinal products is evidence-based and supported by published scientific evidence on the safety and efficacy of those investigational medicinal products in any of the Member States concerned; and
  3. the additional diagnostic or monitoring procedures do not pose more than minimal additional risk or burden to the safety of the subjects compared to normal clinical practice in any Member State concerned

(as per Article 2.2(3) of Regulation EU/536/2014)

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