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Clinical trial

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Also referred to as a trial, interventional clinical trial, interventional study, a research study aimed at evaluating a biomedical or behavioral intervention to see if they are safe and work in people. Clinical trial is defined by the Department of Health and Human Services (DHHS), the International Council for Harmonisation (ICH), and the National Institutes of Health (NIH) as follows:

Clinical trial (DHHS): A research study in which one or more human subject(s) are prospectively assigned to one or more interventions (which may include placebo or other control) to evaluate the effects of the interventions on biomedical or behavioral health-related outcomes. Common Rule, 2018 Requirements: 45 CFR 46.102, Definitions for the Purposes of This Policy; NIH Grants Policy Statement, Glossary

Interventional study/clinical trial ( A type of clinical study in which participant(s) are assigned to groups that receive one or more intervention/treatment (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. The assignments are determined by the study’s protocol. Participants may receive diagnostic, therapeutic, or other types of interventions. NIH Glossary of Common Site Terms; NIH Learn About Clinical Studies

NOTE: National Institutes of Health (NIH) has developed a checklist to help investigator(s) and sponsor(s) determine if a study is considered a clinical trial that is required to be registered on NIH: Checklist for Evaluating Whether a Clinical Trial or Study is an Applicable Clinical Trial (ACT)

Clinical trial/study (ICH GCP): Any investigation in human subjects intended to discover or verify the clinical, pharmacological and/or other pharmacodynamic effects of an Investigational Product (IP), and/or to identify any adverse reactions to an investigational product, and/or to study absorption, distribution, metabolism, and excretion of an investigational product with the object of ascertaining its safety and/or efficacy. ICH GCP, 1.12

NOTE: In the ICH definition the terms clinical trial and clinical study are synonymous.

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