Discrepancy Status

The discrepancy status is a designation that describes the current state of a CRF with regard to discrepancies. The discrepancy status describes the way a discrepancy appears to a user of a particular role. The same discrepancy at the same point in time can therefore appear differently to different users.

RDC Onsite uses the following statuses to track the discrepancies in a CRF:

• Active
• Other
• Hidden
• Closed
• None

For more information, see:

• Active and Other Discrepancies
  
• Hidden Discrepancies
  
• Closed Discrepancies
  
• Colors Indicate Discrepancy Status
  

Active and Other Discrepancies

Active discrepancies are those discrepancies that are assigned to you or your user role for action. Your action may be to resolve the discrepancy or to route the discrepancy to another user for resolution.

Other discrepancies are those discrepancies that are assigned to another user role for action. A discrepancy that appears as Active to your user role appears as Other to another user role and vice versa.

An open status refers to CRFs that have active discrepancies, other discrepancies, or both. Open discrepancies require action and resolution.

The status of a discrepancy changes when you either resolve it or route it. If you resolve a discrepancy, its status changes from open to closed. However, if you only update the discrepancy, for example, by editing comments, its status does not change.

Hidden Discrepancies

A hidden discrepancy is a discrepancy that you cannot see because of your user role.

Closed Discrepancies

A closed discrepancy is a resolved discrepancy. To close a discrepancy, you must specify a resolution reason that is saved as part of the discrepancy record.

A system-generated discrepancy becomes obsolete if you update data in conformance with the edit checks. Specifically, the discrepancy becomes obsolete whenever the edit check that originally raised the discrepancy is executed again: upon updating the field, saving the CRF, validating the patient, or running batch validation. RDC Onsite does not display obsolete discrepancies but does maintain an audit history for the field.

You can manually resolve, and thereby close, both system-generated and manual discrepancies. You can resolve a discrepancy by correcting the data, updating the data, responding to a monitor's query, or re-confirming data veracity.

A clean status refers to CRFs that have either no discrepancies or only closed discrepancies (none or closed).

Colors Indicate Discrepancy Status

RDC Onsite uses color to indicate the status of discrepancies in a CRF.

For example, to alert you to an active discrepancy, RDC Onsite highlights all patient icons and CRF icons related to the particular discrepancy in red. Similarly, to mark discrepancies with a status of other, RDC Onsite highlights all icons in yellow.

See the below table for more information on the colors that RDC Onsite uses to indicate the discrepancy status.

Discrepancy Category	Discrepancy Status	Patient Icon	CRF Icon	Field in the Data Entry Window
Open	Active	Red	Red	Red
Open	Other	Yellow	Yellow	Yellow
Clean	Closed	White	White	Green
Clean	None	White	White	Green