# Subjects: Subject Status Counts

The Subjects: Subject Status Counts folder contains reporting elements that calculate subject counts that are based on subject state. The listed subject states are internal to the InForm application. Whether these states correlate to actual clinical states depends on your use of InForm features.

A subject can be in only one state at a time in the InForm application. Therefore, if a subject is randomized after being enrolled in the InForm application, the current state for the subject is Randomized, not Enrolled.

However, when you create reports on subjects who are still actively participating in the study, you will likely need to see totals that reflect the number of subjects who have ever been enrolled in the study. For example, a count of enrolled subjects should include all subjects who have ever been enrolled in the InForm application, even if their status changed to Randomized, because in clinical terms, a subject who has been randomized is still considered enrolled. Therefore, these subject status counts return totals of subjects who have ever had these states:

- Screened
- Enrolled
- Enrolled Override
- Randomized

To report on subjects who are no longer active in the study, use the Screened Failed, Enrolled Failed, Dropped Out, and Complete subject status counts. Unlike the other subject status counts, these report elements return totals of those subjects currently in any of these states. Subjects will have Dropped Out and Complete status only if your study uses the Study Completion form.

Note: The status assigned to a subject depends on the InForm features you use to set the status. For instance, for a subject to have a randomized state, you must perform subject randomization through the InForm application. For more information, see Subject status requirements.

You can use any of the predefined subject filters to further qualify the Subject Status Count totals.

Subject Status Counts report elements

Report element | Description
--- | ---
Subject Count | Data type: Numeric Description: The number of subjects who enrolled at the site. How calculated: For each site, counts subjects who enrolled at the site, including subjects who are currently assigned other states. Note: The Enrollment form, designed according to InForm specifications, must be completed for the subject. UUID: PF_SC_COMPLETECTL Data source: Status is determined by the value on the Enrollment form, which is stored in the Reporting and Analysis database. Status is set to 1 when the subject is enrolled. Note: You can use any of the predefined subject filters to further qualify this count.
Screened | Data type: Numeric Description: The number of subjects who have ever been in the Screened state in the InForm application. How calculated: Counts subjects who have ever been assigned a Screened status in the InForm application. This count includes subjects whose states have changed from Screened to a new state. Data source: Status is determined by the Screening form and stored in the Reporting and Analysis database. The status count is derived from the status and is set to 1 when the subject enters that status. Note: The Screening form must be completed for the subject for the report to display this information.
Screen Failed | Data type: Numeric Description: The number of subjects who have a current status of Screened Failed in the InForm application. How calculated: Counts subjects who were rejected by the InForm screening process, based on some screening eligibility requirement that was not met. Subjects can have a status of Screened Failed in the InForm application only if screening eligibility requirements are being used for your study. A subject is not counted if the screen failure was overridden for the subject. Data source: Status is determined by the Screening form and stored in the Reporting and Analysis database. The status count is derived from the status and is set to 1 when the subject enters that status.
Enrolled | Data type: Numeric Description: The number of subjects who have ever been enrolled in the study through the InForm application. How calculated: Counts subjects whose Enrollment form was completed and successfully submitted. This count includes: Subjects whose states have changed from Enrolled to a new state. All subjects who have ever been in the Enrolled state. Subjects who have gone through the enrollment override process. Data source: Status is determined by the value on the Enrollment form, which is stored in the Reporting and Analysis database. Status is set to 1 when the subject is enrolled. Note: The Enrollment form must be completed for the subject for the report to display this information.
Enrolled Failed | Data type: Numeric Description: The number of subjects who have a current status of Enrolled Failed in the InForm application. How calculated: Counts subjects whose Enrollment form was rejected by the InForm application, based on some eligibility requirement that was not met. This count includes subjects whose current states have changed from Enrolled Failed to a new state. A subject is not counted if the enroll failure was overridden for the subject. Subjects can have this status only if the enrollment eligibility requirements are being used in the InForm application for your study. Data source: Status is determined by the value on the Enrollment form, which is stored in the Reporting and Analysis database. Status is set to 1 when the subject is enrolled. Note: You can use any of the predefined subject filters to further qualify this count.
Enrolled Override | Data type: Numeric Description: The number of subjects who initially failed the InForm screening or enrollment process, but whose failure was overridden in the InForm application. How calculated: Counts subjects who were screened or enrolled successfully through the InForm Enrolled Override process. This count includes all subjects whose status has changed from Enrolled Override to a new status. Data source: Status is determined by the InForm Screening/Enrollment override process and stored in the Reporting and Analysis database. The status count is derived from the status and is set to 1 when the subject enters that status.
Randomized | Data type: Numeric Description: The number of subjects in the study who have ever been randomized in the InForm application. Subjects have a status of Randomized immediately after they have been randomized with the InForm randomization feature. How calculated: Counts subjects who have ever been randomized in the InForm application. This count includes subjects whose status has changed from Randomized to a new status. If you randomize subjects outside of the InForm application, the randomized subject count will always be 0. Data source: Status is determined by the InForm Randomization feature and stored in the Reporting and Analysis database. The status count is derived from the status and is set to 1 when the subject enters that status. Note: The randomization process, as designed per InForm requirements, must be completed for the subject for the report to display this information.
Dropped Out | Data type: Numeric Description: The number of subjects who have a current status of Dropped Out. How calculated: Counts subjects who have dropped out of the study, as recorded in the Study Completion form for that subject. Data source: Replicated from the InForm transactional database to the Reporting and Analysis database. Note: The Study Completion form, as designed per InForm requirements, must be completed for the subject for the report to display this information.
Subject Complete | Data type: Numeric Description: The number of subjects who have a current status of Complete. How calculated: Counts subjects who have a current status of Complete, as recorded in the Study Completion form for that subject. Data source: Replicated from the InForm transactional database to the Reporting and Analysis database. Note: The Study Completion form, as designed per InForm requirements, must be completed for the subject for the report to display this information.

Copyright © 2013 Oracle and/or its affiliates. All rights reserved.