Defining the Review Statuses for Discrepancies

When a user takes action on a discrepancy, the discrepancy goes to a new review status. For system-generated discrepancies (univariate and multivariate), the system assigns the default review status. For manual discrepancies, the user selects the review status.

One task you perform in configuring your discrepancy management system is to map an action to a resultant review status. You use the DISCREPANCY REV STATUS CODE installation codelist to define all the discrepancy review statuses possible to use in your discrepancy management workflow.

Both the RDC and the Oracle Clinical discrepancy management systems use the DISCREPANCY REV STATUS CODE codelist.

RDC uses the text string in the Description field to display the status of a discrepancy in any discrepancy management-related window, form, page, or report. Oracle Clinical uses the text string in the Short Value field to display the status of a discrepancy.

For more information, see:

• Default Entries for the DISCREPANCY REV STATUS CODE Codelist
  
• Rules for the DISCREPANCY REV STATUS CODE Codelist
  

Default Entries for the DISCREPANCY REV STATUS CODE Codelist

The following table lists the entries in the DISCREPANCY REV STATUS CODE installation codelist following the initial installation of Oracle Clinical.

Short Value	Long Value	Description
CLOSED	CLOSED	The system sets a discrepancy's status to Closed when it is resolved by either updating the data to a nondiscrepant value or changing the validation procedure or question attribute in such a way that the existing data is no longer discrepant. The discrepancy's system status changes to Obsolete and the discrepancy is removed from its DCF (if any) and no longer appears as current in discrepancy reports.
CRA REVIEW	Null	Under CRA Review
INV REVIEW	Null	Under Investigator Review
RESOLVED	IRRESOLVABLE	Not assigned to any person or process. Setting a discrepancy's status to RESOLVED does not cause the system to close the discrepancy. That happens only when the data is no longer discrepant, either because the data has been updated to a nondiscrepant value or because the validation procedure or question attribute that flagged the value as discrepant has been changed in such a way that the existing value is no longer considered discrepant.
IRRESOLVABLE	IRRESOLVABLE	Irresolvable (That is, closed. Cannot be resolved.)
TMS EVALUATION	TMS EVALUATION	TMS Evaluation
UNREVIEWED	Null	Not yet reviewed
TMS IN PROGRESS	TMS IN PROGRESS	TMS in Progress - Set/Reset by system
DM REVIEW	Null	Under DM Review
INT DM REV	Null	Internal - Under DM Review
INT CRA REV	Null	Internal - Under CRA Review

Rules for the DISCREPANCY REV STATUS CODE Codelist

When entering and modifying values in the DISCREPANCY REV STATUS CODE reference codelist, you must follow these rules:

• The codelist must contain at least one short value entry with a long value of IRRESOLVABLE, which indicates that a user must specify a resolution reason when setting a discrepancy to this status. By default, the codelist contains the short values RESOLVED and IRRESOLVABLE, which are each assigned the long value IRRESOLVABLE.
• The codelist must contain a short value entry of UNREVIEWED. The Active check box corresponding to the value must always be selected. The UNREVIEWED value is the system-coded default status of any newly created discrepancy, except multivariate discrepancies. For multivariate discrepancies, the initial review status is defined in the Details block of the Oracle Clinical validation procedure that generates the discrepancy.
• The Active check box must be selected for each review status that you want to allow for a certain user role. In other words, if you set an entry in a DISCREPANCY STATUS role codelist to active, then you must also set the corresponding entry in the DISCREPANCY REV STATUS CODE codelist to active.

  Conversely, if you set an entry in the DISCREPANCY REV STATUS CODE codelist to inactive, you must also set the corresponding entry in each DISCREPANCY STATUS role codelist to inactive. If not, users receive an error message that problems exist with the discrepancy management system.