14.1 Define and Classify Query

Definition

The Note and Discrepancy module help you communicate and manage data issues.

We use Discrepancies Notes in some below cases :

• You can create a Discrepancy Note when capturing or validating data in order to flag an item as incomplete or as having a value that is not expected.
• You can leave a required field in a CRF empty if you provide a Discrepancy Note that provides an explanation.
• The system can automatically create a Discrepancy Note when you save a CRF that contains errors in the data, as determined by edit checks.
• The system can also automatically generate Discrepancy Notes when Rules run.

A Discrepancy Note has four characters, which the user assigns when creating the note:

• Note Type
• Status
• Description
• Detailed Note

Note Type

There are four types of Note:

• Failed Validation Check
• Query
• Reason for Change
• Annotation 

Failed Validation Check

A Failed Validation Check Note Type is for data that do not comply with expected values. A Failed Validation Check Discrepancy Note can be created when:

• User can manually create this Note Type
• The system can automatically generate this Note Type when validating a field, using Rules or when running an Edit Check. System first displays a warning message. If the user does not change the value to one that conforms to the expected values for the Item, it creates a Failed Validation Check Discrepancy Note
• System also generates this Note Type when importing data if the data does not conform to expected values

After creating Failed Validation Check, this note type has "New" status. Then user can update or propose resolution for it. User who has permission will review and decide whether data is acceptable.  

Query

A Query Note Type is used to ask a question about data provided for an Item. The cycle proccessing of Query is :

• Creator make and assign a query to a user to ask about an Item that seems incomplete or incorrect, even though the item has met all automated edit checks. So Query has "New" status.
• Then the user can propose resolution for it. In case user need more consideration, user can set it is "Updated".
• Finally, creator review this response and set this query by "Closed" in case he is satisfied OR assigns it back to the user in case need more information  

Reason for Change

If a Study is configured to include Force Reason for Change, any change made to the CRF after the CRF data entry is marked completed requires a Discrepancy Note. Typically, use the Reason for Change Note Type to address the change, but the change can also be addressed with a Query or Failed Validation Check Note Type. A Reason for Change Discrepancy Note always has a status of Not Applicable.

Annotation

Annotation Discrepancy Notes are to make comments or provide information about the data that cannot be adequately represented in the CRF. Annotation Notes always have a status of Not Applicable.

Status

• 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 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.