Clinical Study

EU: Clinical Trials Regulation – ‘Clinical study’ means any investigation in relation to humans intended:

  1. to discover or verify the clinical, pharmacological or other pharmacodynamic effects of one or more medicinal products;
  2. to identify any adverse reactions to one or more medicinal products; or
  3. to study the absorption, distribution, metabolism and excretion of one or more medicinal products;

with the objective of ascertaining the safety and/or efficacy of those medicinal product (as per Article 2.2(1) of Regulation EU/536/2014)

USA: 42 CFR 11 – Clinical study means research according to a protocol involving one or more human subjects to evaluate biomedical or health-related outcomes, including interventional studies and observational studies (as per 42 CFR 11.10)

Note: 42 CFR 11 (Clinical Trials Registration and Results Information Submission) defines the clinical trial registration requirements for clinicaltrials.govClinical Study

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