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Siebel Clinical Trial Management System Guide > Administering Clinical Subjects and Clinical Visits >
About Automatic Tracking of Subject Status
This topic describes the fields that are used by the mechanism for automatically tracking subject status, 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 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 appears 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 This field is null for status records such as Randomized and Withdrawn.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 Records in Subject Status MVG
Table 6 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 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 Records in Subject Status MVG
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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Withdrawn Reason |
Withdrawn |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 defined by the status value in the Visits list for that visit |
Override Status |
Missed or the status defined by the status value in the Visits list for that visit |
Status Tracking Fields that Trigger Update Operations on Fields of Subject Status MVG
Table 7 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 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 Fields of Subject Status MVG
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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 defined in the Visits list for that visit. |
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