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Status setting

In EDC, with the Status Setting functionality, you can configure the statistical values displayed for your study subject count under the DATA ENTRY > Site List page.

Statistical values configurable via status setting
Figure 1. Statistical values configurable via status setting

The status settings that are currently configured for your study can be viewed under the Status Setting tab, the elements of which are explained in the following table.

Status Setting tab
Figure 2. Status Setting tab

Column

Details

Status Name

Represents the name of the subject status.

Display Name

Represents the name of the status that is displayed in the EDC system user interface (UI), for instance, under the Site List page.

Description

Represents the status description that provides insights into the logic behind its value.

For instance, by adding a description to the In Screening status, you can help other users understand that this value represents all subjects that are currently under the Registered phase.

Phase Setting

Represents the subject phase(s) pertinent to the status.

For instance, the Screen Pass status includes all the subjects that are currently under the Enrolled, Randomized, and Completed phases.

Status

Shows the status of the setting: active or inactive. Only the active statuses are available elsewhere in the EDC system, for instance, under the Site List page. Inactive statuses are only available in the Status Setting table.

With the status setting functionality, you can do the following:

In this section:

A participant who is enrolled in a clinical trial and assigned to the site.

A specific phase that a subject has to complete in the course of a clinical trial to move further to the next phase. For instance, Screening, Enrolled, Randomized, and others.

subject_phase.png

In eClinical, subject phases are designed individually for each study via the SD application, although they are referenced in others, like IWRS or EDC.