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ClinicalTrials.gov Protocol Registration Data Element Definitions for Interventional and Observational Studies October 1, 2020This document describes the definitions for protocol registration data
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What is results data element definitions?
Results data element definitions refer to the specific pieces of information that must be reported for a particular set of results.
Who is required to file results data element definitions?
All organizations or individuals who are involved in the collection, analysis, and reporting of results data are required to file results data element definitions.
How to fill out results data element definitions?
Results data element definitions can be filled out by providing accurate and detailed information for each required data element in the designated format.
What is the purpose of results data element definitions?
The purpose of results data element definitions is to ensure consistency and accuracy in reporting results data across different organizations and individuals.
What information must be reported on results data element definitions?
Results data element definitions typically require information such as the date of the results, the source of the results, and any relevant contextual information.
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