Results Submission
The process of submitting and updating summary information about the results of a clinical study to a structured, public Web-based results database, such as the ClinicalTrials.gov results database.
READ MOREResults First Received Date
The date that summary information about the results of a clinical study was first submitted to the ClinicalTrials.gov results database.
READ MOREResults Database
A structured online system, such as the ClinicalTrials.gov results database, that provides the public with access to summary results and registration information for completed or terminated clinical studies. Note: The […]
READ MOREResponsible Party
The sponsor, sponsor-investigator, or sponsor-designated principal investigator who is responsible for submitting information about a clinical study to ClinicalTrials.gov and updating that information. (See also Responsible Party data element on […]
READ MOREResearch
A systematic investigation, study or experiment designed to develop or contribute to generalizable knowledge. The term encompasses basic and applied research (e.g., a published article, book, or book chapter) and […]
READ MORERegulatory Authorities
Bodies having the power to regulate. In the ICH GCP guideline, the expression “Regulatory Authorities” includes the authorities that review submitted clinical data and those that conduct inspections. These bodies […]
READ MOREReporting (or Comparison) Group
A grouping of participants in a clinical study that is used in summarizing the data collected during the study. This grouping may be the same as or different from a […]
READ MORERegistry
A structured online system, such as ClinicalTrials.gov, that provides the public with access to summary information about ongoing and completed clinical studies.
READ MORERegistration
The process of submitting and updating summary information about a clinical study protocol from its beginning to end, to a structured, Web-based registry that is accessible to the public, such […]
READ MORERecruitment Status
Open Studies Not yet recruiting – The study has not started recruiting participants. Recruiting – The study is currently recruiting participants. Available for expanded access – An Expanded Access program […]
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