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Subjects: Subject Status (text)

The elements in the Subjects: Subject Status (text) reporting topic allow you to create reports that describe subject status.

Note: The subject states listed here are states internal to the InForm application. They may or may not correlate with clinical state definition, since events like screening and randomization are often performed outside of the InForm application.

Subject Status (text) report elements

Report element

Description

Subject Status

Data type: String

Description: The current InForm subject status. Subjects can be in only one state at a time in the InForm application. Valid values are:

  • Screened—The Screening form for the subject was started, but the subject is not enrolled.
  • Screen Failed—The subject has failed the InForm screening process.
  • Enroll Failed—The subject has passed the InForm screening process, but failed the enrollment process.
  • Enrolled—The subject was properly enrolled in the InForm application, but has not reached the status of randomized, completed, or dropped out.
  • Randomized—The subject was enrolled and has been randomized in the InForm application, but is not yet completed or dropped out.
  • Complete—The subject has completed the study, as recorded in the Complete control of the Study Completion form for that subject.
  • Dropped out—The subject has dropped out of the study, as recorded in the Complete control of the Study Completion form for that subject.

Data source: Replicated from the InForm transactional database to the Reporting and Analysis database.

Screen Failure Reason

Data type: String

Description: Text that indicates why the subject failed the screening process.

Data source: Replicated from the InForm transactional database to the Reporting and Analysis database.

Enroll Failure Reason

Data type: String

Description: Text that indicates why the subject failed enrollment.

Data source: Replicated from the InForm transactional database to the Reporting and Analysis database.

Enroll Override Reason

Data type: String

Description: Text that indicates why the screening or enrollment failure was overridden for the subject.

Data source: Replicated from the InForm transactional database to the Reporting and Analysis database.

Drop Out Reason

Data type: String

Description: Text that indicates why the subject dropped out of the study. The dropout reason is clinical data that is specified on the Study Completion form for the subject.

Note: This report displays only those reasons that were specified when a subject dropped out of the study. If a dropout reason was never used, the reason does not appear in this report.

UUIDs: PF_SC_COMPLETECTL, PF_SC_REASONCTL_internal_reason_value

Data source: Replicated from the InForm transactional database to the Reporting and Analysis database.

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