Clinical Research Centre
Health care-based organizations devoted to clinical research, with designated beds, equipment, medical and study-nurse staff, allowing enrolment and investigation of patients in the early phases of drug trials and in non-therapeutic studies
Clinical Trial
Clinical Trial (Portuguese Law n.º 21/2014 de 16 de Abril and ICH-GCP(E6)) Any investigation in human subjects intended to discover or verify the clinical, pharmacological and/or other pharmacodynamic effects of an investigational product(s), and/or to identify any adverse reactions to an investigational product(s), and/or to study absorption, distribution, metabolism, and excretion of an investigational product(s) with the object of ascertaining its safety and/or efficacy.
Clinical Trial Unit
Clinical Trial Unit : Organizations/Units for managing clinical trials, namely randomised clinical trials (phase II-IV), prognostic, diagnostic studies, and meta-analyses, dealing with the design of the study, its organisation, logistics, centre selection, data management, monitoring, data analysis, pharmacovigilance and reporting