Subject information

Site Code

Represents the code of the site to which the selected subject belongs.

[Unique ID Label]

Represents the ID of the selected subject.

The field name depends on the unique ID label configuration of your study.

Randomization ID

Represents the randomization ID of the subject.

If the study does not use randomization or the subject is not randomized, then the randomization ID is not assigned and so nothing is displayed in this field.

Current Arm

Represents the name of the arm to which the selected subject belongs.

Randomized Date

Represents the randomization date and time. The field name varies according to the phase, to which the subject is moved upon randomization. If the study does not use randomization or the subject is not randomized, then the randomization ID is not assigned and nothing is displayed in this field.

Current Status

Represents the current status of the subject, which can be Active or Inactive. When a subject is inactive, they are no longer part of a study, and you cannot change the phase or discontinue an inactive subject.

Treatment Period

Represents the treatment period of the subject.

Cohort (System)

Represents the name of the cohort to which the subject belongs.

Current Phase

Represents the current phase of the subject.

Unbind Request Status

Represents the current unblind request status.

First Unblinded By

If the subject is unblinded, this field represents the name of the user who unblinded the subject, otherwise, this field is not available.

First Unblinded Time

If the subject is unblinded, this field represents the date and time at which the subject has been unblinded, otherwise, this field is not available.

Unblind Reason

If the subject is unblinded, this field represents the reason for unblinding the subject, otherwise, this field is not available.

REQUEST UNBLIND

Select to request the subject unblind.

REVIEW UNBLIND REQUEST

Select to review the subject unblind request and either approve or revoke this request.

UNBLIND SUBJECT

Select to unblind a subject at the study or visit/period level.

UNBLIND HISTORY

Select to view the subject's unblind history.

INACTIVATE/ACTIVATE

Select to inactivate an active subject or select to activate an inactive subject.

DISCONTINUE

Select to discontinue a subject.

REVERSE

Select to reverse a subject phase to the previous phase.

Change Phase

In this block, you can change the phase of the selected subject.

Subject-specific Factor

In this block, you can select a subject-specific factor for the subject.

Sync Mapping Factor to EDC

Select to sync subject-specific factor data to EDC.

Download Subject Report

Select to download a subject report to your computer.