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About Automatic Subject Status Tracking

This topic describes the fields that are used by the automatic subject status tracking mechanism, and the automatic operations that they trigger in the Subject Status MVG. The Subject Status MVG is a multi-value field that contains a history of the subject's status. It contains the following fields.

• Date. The date the status was changed or updated.
• Status. The status of the subject, for example, Screened, Enrolled, or Re-screened.
• Primary. This flag sets the current status, which displays in the Status field of the Subjects view.
• Comments. Comments about the subject's status.
• Visit Type. The type of clinical subject visit, such as Screening or Enrollment. This field is null for status records such as Randomized and Withdrawn.

Status Tracking Fields that Trigger Create and Delete Operations on Subject Status MVG Records

Table 6 lists the status tracking fields that trigger create and delete operations on Subject Status MVG records. The Subject Status MVG records are automatically updated as follows:

• Populating a status tracking field listed in Table 6 automatically creates the corresponding status record in the Subject Status MVG, including Status, Date, and Visit Type fields, where applicable
• Deleting a status tracking field listed in Table 6 automatically deletes the entire corresponding status record in the Subject Status MVG, including the Status, Date, and Visit Type fields, where applicable.

  Table 6. Status Tracking Fields that Trigger Create and Delete Operations on Subject Status MVG Records

  Status Tracking Field	Subject Status MVG Record Automatically Created or Deleted
  Random ID	Randomized
  Screen Failure Reason	Screen Failure
  Withdrawn Reason	Withdrawn
  Early Termination Reason	Early Terminated
  Missed	Missed
  Completed	[Status defined by the Status value in the Visits list for that visit]
  Override Status	Missed or [Status defined by the Status value in the Visits list for that visit]

Status Tracking Fields that Trigger Update Operations on Subject Status MVG Fields

Table 7 lists the status tracking fields that trigger update operations on Subject Status MVG Date and Status fields. The Subject Status MVG fields are automatically updated as follows:

• Populating or updating a status tracking field listed in Table 7 automatically triggers an update to the corresponding Date or Status field value in the Subject Status MVG.
• Deleting a status tracking field listed in Table 7 automatically triggers a delete operation on the corresponding Date or Status field value in the Subject Status MVG.

  Table 7. Status Tracking Fields that Trigger Update Operations on Subject Status MVG Fields

  Status Tracking Field	Subject Status MVG Field Automatically Updated
  Randomized Date	Date field in the Randomized Subject Status MVG record
  Screen Failure Date	Date field in the Screen Failure Subject Status MVG record
  Withdrawn Date	Date field in the Withdrawn Subject Status MVG record
  Early Terminated Date	Date field in the Early Terminated Subject Status MVG record
  Completed Date	Date field in the Subject Status MVG Subject Status MVG record
  Override Status	Status field in the Subject Status MVG is updated to Missed or [Status value defined in the Visits list for that visit]