The status for a Discrepancy Note provides an indication of who is responsible for the next step. The Discrepancy Note Type determines what status values are allowed. These are the possible values:
- New : The initial status for a Query or Failed Validation Check Note Type.
- Updated : Used when responding to a Note, but the response requires further follow up or additional information.
- Resolution Proposed : When a user addresses a Note by fixing a data problem or by explaining why the existing data is correct, the user provides an explanation in a child Note, and sets the status to Resolution Proposed. A Monitor, Data Manager or Study Director then reviews the proposed resolution and updates the status.
- Closed : The final action for a Failed Validation Check or Query Note Type. When a Note has a status of Closed, it cannot be changed in any way. Child Notes cannot be added and the status must remain Closed. Only users with certain Roles can mark a Discrepancy Note as Closed.
- Not Applicable : This status is for Reason for Change and Annotation Note Types because no further action is required. The Not Applicable status cannot be used for Failed Validation Check and Query Note Types.
When there is more than one Discrepancy Note associated with a CRF Item, the most urgent status is shown in summary presentations that include Discrepancy Note status. When you view the Discrepancy Notes for the Item, you see the status for each Discrepancy Note.