About Automatic Tracking of Subject Status

This topic describes the fields that the mechanism for automatically tracking subject status uses, and the automatic operations that they trigger in the Subject Status MVG (multi value group). The Subject Status MVG contains a history of the subject's status. It contains the following fields.

• Date. The date that users change or update the status.

• Status. The status of the subject, for example, Screened, Enrolled, or Re-screened.

• Primary. A flag that sets the current status. This field appears in the Status field of the Subjects view.

• Comments. Comments about the subject 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 This field is null for status records, such as Randomized and Withdrawn.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 Records in Subject Status MVG

Table 5-1 lists the status tracking fields that trigger create and delete operations on the records in the Subject Status MVG. The records in the Subject Status MVG are automatically updated as follows:

• Populating a status tracking field listed in Table 5-1 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 5-1 automatically deletes the entire corresponding status record in the Subject Status MVG, including the Status, Date, and Visit Type fields, where applicable.

Table 5-1 Status Tracking Fields that Trigger Create and Delete Operations on Records in Subject Status MVG

Status Tracking Field	Record in Subject Status MVG Automatically Created or Deleted
Random ID	Randomized
Screen Failure Reason	Screen Failure
Withdrawn Reason	Withdrawn
Early Termination Reason	Early Terminated
Missed	Missed
Completed	Status that the status value in the Visit Plans list for that visit defines
Override Status	Missed, or the status that the status value in the Visit Plans list for that visit defines

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

Table 5-2 lists the status tracking fields that trigger update operations on the Date and Status fields of the Subject Status MVG. The fields of the Subject Status MVG are automatically updated as follows:

• Populating or updating a status tracking field listed in Table 5-2 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 5-2 automatically triggers a delete operation on the corresponding Date or Status field value in the Subject Status MVG.

Table 5-2 Status Tracking Fields that Trigger Update Operations on Fields of Subject Status MVG

Status Tracking Field	Field of Subject Status MVG Automatically Updated
Randomized Date	Date field in the record of the Subject Status MVG with a Status field of Randomized
Screen Failure Date	Date field in the record of the Subject Status MVG with a Status field of Screen Failure
Withdrawn Date	Date field in the record of the Subject Status MVG with a Status field of Withdrawn
Early Terminated Date	Date field in the record of the Subject Status MVG with a Status field of Early Terminated
Completed Date	Date field in the record of Subject Status MVG
Override Status	Status field in the Subject Status MVG is updated to Missed, or the status value in the Visit Plans list for that visit.