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During the process of completing a trial abstraction, the system checks all abstracted data for potential errors and omissions, and all required fields for consistency. For example, it compares the number of arms reported in the interventional trial Design Details with the number of arm records listed on the Arms page. Major steps for completing an abstraction currently in the "Accepted" or "Abstracted Verified (Response and No Response)" trial processing status are as follows:
Trial Validation Criteria
The following rules, among others provided throughout this document, determine the criteria for completion of Complete trials:
Additionally, if the trial is designated for submission to ClinicalTrials.gov, the following rules apply:
Non-Interventional Trial Groups/Cohorts CriteriaThe following rules pertaining to groups/cohorts determine the criteria for completion of non-interventional trials:
Trial ReportingUpon trial abstraction validation or abstraction update, you can send a trial summary report that includes the summary of the abstraction and an XML file that contains abstracted trial records formatted for submission to ClinicalTrials.gov.
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