ClinicalTrials.gov is an online database of clinical trials. At UConn Health, Principal Investigators are responsible for registering and posting results per the federal regulations as well journal policies. That National Institutes of Health definition of a clinical trial is a research study¹  in which one or more human subjects² are prospectively assigned³ to one or more interventions⁴ (which may include placebo or other control) to evaluate the effects of those interventions on health-related biomedical or behavioral outcomes.⁵  

Do you have questions about ClinicalTrials.gov registration or results posting? To schedule a virtual or in-person session with the UConn Health contact for ClinicalTrials.gov, email Ellen Ciesielski, Research Compliance Monitor in Research Integrity & Compliance in the OVPR. To learn more about ClinicalTrials.gov requirements, please see our webpages.

 

 

 

 

 

¹See Common Rule definition of research at 45 CFR 46.102(d).

²See Common Rule definition of human subject at 45 CFR 46.102(f).

³The term “prospectively assigned” refers to a pre-defined process (e.g., randomization) specified in an approved protocol that stipulates the assignment of research subjects (individually or in clusters) to one or more arms (e.g., intervention, placebo, or other control) of a clinical trial.

⁴An intervention is defined as a manipulation of the subject or subject’s environment for the purpose of modifying one or more health-related biomedical or behavioral processes and/or endpoints.  Examples include:  drugs/small molecules/compounds; biologics; devices; procedures (e.g., surgical techniques); delivery systems (e.g., telemedicine, face-to-face interviews); strategies to change health-related behavior (e.g., diet, cognitive therapy, exercise, development of new habits); treatment strategies; prevention strategies; and, diagnostic strategies.

⁵Health-related biomedical or behavioral outcome is defined as the pre-specified goal(s) or condition(s) that reflect the effect of one or more interventions on human subjects’ biomedical or behavioral status or quality of life.  Examples include:  positive or negative changes to physiological or biological parameters (e.g., improvement of lung capacity, gene expression); positive or negative changes to psychological or neurodevelopmental parameters (e.g., mood management intervention for smokers; reading comprehension and /or information retention); positive or negative changes to disease processes; positive or negative changes to health-related behaviors; and, positive or negative changes to quality of life.