Defining the Possible 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.

Both the Oracle Clinical and RDC discrepancy management systems use the DISCREPANCY REV STATUS CODE installation reference codelist to define all the discrepancy statuses possible to use in your discrepancy management workflow.

RDC Onsite 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.

You can edit the review status codes available and sequence the order in which they appear in lists of values. If you add a status, you must do the following as well:

• In Oracle Clinical, update all profiles with the new status by clicking the Add Review Status button; see Customizing Profiles.
• In RDC, add the new status' short value to each DISCREPANCY STATUS ROLE codelist. If the short value is IRRESOLVABLE in the DISCREPANCY REV STATUS CODE reference codelist, it must have a long value of CLOSED in the DISCREPANCY STATUS ROLE codelists.

  In addition, if you want users of a particular role to be able to route discrepancies to the status, add the status to the relevant DISCREPANCY ACTIONS ROLE codelist. See Configuring Discrepancy Display by User Role andConfiguring the Actions Allowed on Discrepancies.

In this section:

• 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 codelist following the initial installation of Oracle Clinical.

Table 3-12 Default Entries for the DISCREPANCY REV STATUS CODE Codelist

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

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.

There are additional statuses that are not included in the reference codelist:

OBSOLETE: When the data is no longer discrepant—either because the data is updated or because the validation procedure or question attribute that flagged the data as discrepant is changed in such a way that the data is no longer discrepant—the system automatically updates the system status to OBSOLETE.

PASSIVE REVIEW is a status that allows you to reduce the number of discrepancy queries and the number of discrepancies on a DCF by associating one or more discrepancies with a primary discrepancy. You can then include all the discrepancies in a single query. When you create the DCF, do not include discrepancies marked as Passive Review in the printed DCF.

For example, if you have a page with three lab results and all three lab results are missing, you would have three discrepancies such as:

• AST lab units missing, please provide.

• ALT lab units missing, please provide.

• RBC lab units missing, please provide.

You could send three queries, but to save time, money, and paper you could choose to send only one query such as: Page 7 all lab units are missing, please provide.

To do this, mark the second two discrepancies for passive review associated with the first discrepancy as the primary discrepancy. Then create a DCF, include all three discrepancies in the DCF, but mark the primary discrepancy's status as For Distribution and the other discrepancies' status as Not For Distribution. When you print the DCF, only the primary discrepancy appears, but all three are included in the electronic DCF. When the answer to the query returns, you can update the data for all three discrepancies.

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, whose initial review status is defined in the Details block of the Oracle Clinical validation procedure that generates the discrepancy.

• The Description field must be entered for each short value. In RDC, the system uses this value to display the status of discrepancies in any discrepancy management-related windows, forms, tasks tabs, or reports. In Oracle Clinical, the system uses the short value to describe the status of a 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.