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  • Subject: Study subject level reporting of demographic data.
    • Subject accrual is expected to be reported for Complete studies, both Interventional and Non-Interventional, and is the default accrual reporting type.
  • Partial Subject: Requires the reporting of Study Subject ID, Registration Date and Participating Site data only. The other accrual data elements are optional.
    • Partial Subject accrual was implemented for unique instances when full Subject/patient-level accrual reporting is not feasible.
    • The reporting of Partial Subject accrual on a Complete Interventional trial requires an approval request submitted to the CTRO (NCICTRO@mail.nih.gov).
    • Centers can change the default accrual reporting type on Complete Non-Interventional studies to Partial Subject within the Accrual application, as long as accrual has not been reportedreported. If accrual has been reported, then the following actions are required:
      • Any previously reported accrual will need to be nullified prior to the change in accrual reporting type.
      • An approval request will need to be submitted to the CTRO (NCICTRO@mail.nih.gov) to change the accrual reporting type to Partial Subject.
  • Summary: Total number (count) of study subjects accrued per site on a given study.
    • Summary accrual is expected to be reported for Abbreviated/Imported studies, and is the default accrual reporting type.
    • Centers can change the default accrual reporting type on Complete Non-Interventional studies to Summary within the Accrual application as long as accrual has not been been reported. If accrual has been reported, then the following actions are required:
      • Any previously reported accrual will need to be nullified prior to the change in accrual reporting type.
      • An approval request will need to be submitted to the CTRO (NCICTRO@mail.nih.gov) to change the accrual reporting type to Summary. 
    • The reporting of Summary accrual on a Complete Interventional trial requires an approval request submitted to the CTRO (NCICTRO@mail.nih.gov). 
    • The reporting of Subject or Partial Subject accrual on an Abbreviated/Imported study requires an approval request submitted to the CTRO (NCICTRO@mail.nih.gov).

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