Subject status requirements

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Subject status requirements

The subject status that appears in reports depends on which InForm features you use to set the state. For instance, to display status data for a subject in the Randomized state, you must perform subject randomization through the InForm application.

This table outlines the requirements for subject status in the InForm application. If your organization does not take advantage of these InForm features, subject status reporting capabilities are limited in the Reporting and Analysis module.

Subject status requirements

Subject status

Required action in the InForm application

Screened

InForm Screening form (as designed per InForm requirements) must be successfully submitted for the subject.

Enrolled

InForm Enrollment form (as designed per InForm requirements) must be successfully submitted for the subject.

Screened Failed

InForm Screening form (as designed per InForm requirements) must be submitted for the subject. The subject subsequently fails the InForm screening process.

Enrolled Failed

InForm Enrollment form (as designed per InForm requirements) must be submitted for the subject. The subject subsequently fails the InForm enrollment process.

Enrolled Override

InForm Enrollment Override process must be successfully completed after the subject initially fails screening or enrollment.

Randomized

Subject must be randomized in the InForm application.

Dropped Out

InForm Study Completion form (as designed per InForm requirements) must be completed for the subject. The form must indicate that the subject has dropped out of the study.

Completed

InForm Study Completion form (as designed per InForm requirements) must be completed for the subject. The form must indicate that the subject has completed the study.

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