Maintain Discrepancy Database Window Fields

Table 4-2 Maintain Discrepancy Database Window: Discrepancy Panel

Field	Description
Patient	The patient about whom the discrepant response was collected.
Visit	The visit at which the discrepant response was collected.
Subevent	The subevent, if any, at which the discrepant response was collected.
DCM Name	The DCM of the question whose response triggered the discrepancy.
System	This field stores the system status. Oracle Clinical maintains a system status of either CURRENT or OBSOLETE for discrepancies. A new discrepancy has a system status of CURRENT. Oracle Clinical automatically sets the system status to OBSOLETE when you fix the data or otherwise resolve the problem that created the discrepancy.
Comment	This field stores the comment text, which is an enterable field (except for discrepancies with a review status of CLOSED or a system status of OBSOLETE) for up to 2000 characters of free form text of supplemental information about the discrepancy. The system enters a default value for new discrepancies according to the discrepancy type: for univariate discrepancies, the text is the same as the Category field; for indicator discrepancies, the field is blank; and for multivariate discrepancies the text is taken from the Message field of the Procedure that generated the discrepancy. You can enter the long value for the review status as defined in the DISCREPANCY_REVIEW_STATUS reference codelist by entering three pound signs (###) in the field and saving. You can query for text values in this field.
Review	This field stores the review status. A new discrepancy has a review status of Unreviewed. During the discrepancy management process, you change the review status to reflect the state of investigation into the problem. (See Review Status Code.) 2000 characters maximum.
Inter Com	Reviewer internal comments. 1900 characters maximum.
Resolution	Resolution status; populated only for discrepancies that have been closed. Valid values are set in the installation reference codelist DISCREPANCY RESOLU TYPE CODE.
Res Com	For discrepancies with a value in the Resolution field, the Resolution Comment is an enterable field for up to 2000 characters of free form text of information about why the discrepancy was closed.

Table 4-3 Maintain Discrepancy Database Window: Characteristics Panel

Field	Description
Discrepancy Type	See Discrepancy Types; univariate, multivariate, manual (manual header or manual data point), or indicator.
Category	The discrepancy subtype. For example, univariate discrepancies have categories such as UPPERBOUND, DATA TYPE, DVG, and so on. Multivariate discrepancy categories give information on the data that was compared by the Validation Procedure that created the discrepancy, such as 1- EVENT, 1-DCM or 1-EVENT, 2-DCM.
Failure Type	Severity of the discrepancy (e.g., NORMAL or CRITICAL). You can specify search criteria in this field in query mode. This is a display-only field.
Question Name	(Three-way toggle with Question Name, SAS Label and Default Prompt.) The question whose response is discrepant.
SAS Label	Click the Question Name button to see the SAS Label defined for the question. This text is supplied to the SAS Labels field in SAS views and SAS datasets, to describe the question.
Default Prompt	Click the Question Name, then SAS Label, to see the Default Prompt defined for the question. This is the label displayed in the Data Entry window for the field that collects data for the question.
Occ#	The occurrence number of the question (for questions in Repeating question groups only).
Repeat Sn	The repeat sequence number of the question (for Repeating questions only).
More...	(Multivariate discrepancies only). Click this button to see the response data involved in generating the discrepancy, one or more of which may be discrepant. The Validation Values window appears, listing the questions and their responses that were used as variables in the Validation Procedure that generated the discrepancy. Questions are displayed as they are in the Procedure, as X.QUESTION_NAME where X is the DCM Question Group alias. If you want a question and its response to be included in the discrepancy's DCF, select the DCF Report? box (see Using Data Clarification Forms).
Value Text	(Non-multivariate discrepancies only). The question response value that triggered the discrepancy (if any; may be blank for manual and indicator discrepancies).
Procedure	The name of the Procedure that created the discrepancy (multivariate discrepancies only).
Version	The version of the Procedure that created the discrepancy (multivariate discrepancies only).
Detail	The Detail (program code) of the Procedure that created the discrepancy (multivariate discrepancies only).

Table 4-4 Maintain Discrepancy Database Window: Related Information Panel

Field	Description
Study Site	A site in the context of a study.
Site	A site defined in Oracle Clinical independent of a study.
Visit Date	The date of the visit at which the discrepant response was collected.
Investigator	Code of the Investigator responsible for resolving the discrepancy.
Name	Name of the Investigator responsible for resolving the discrepancy.
Initials	Initials of the patient.
Document #	DCI Page number of the discrepant response. For multivariate discrepancies, the DCI Page number of the question group defined as the primary reference in the definition of the Procedure that generated the discrepancy.
Subset	The DCM Subset containing the discrepant data. For multivariate discrepancies, the DCM Subset containing the question group defined as the primary reference in the definition of the Procedure that generated the discrepancy.
Discrep ID	The unique ID of the discrepancy.
CRF Pages	The page number on the physical Case Report Form containing the discrepant response.
Qualif Value	The response to the Qualifying question, if any, for the DCM containing the question with the discrepant response.
Assoc ID	Enterable field for the ID of a discrepancy that is the root cause of the current discrepancy; whose resolution will trigger the resolution of the current discrepancy. List of values available.
Flexfield 1	Customizable field; may have a user-defined label. Follow your organization's instructions to use this field. See Reference Codelists in the Oracle Clinical Administrator's Guide for information about modifying codelists to customize these fields.
Flexfield 2	Same as above.

Table 4-5 Maintain Discrepancy Database Window: Current DCF Panel

Field	Description
DCF ID	The ID of the DCF associated with this discrepancy.
Status	The DCF Status of the DCF associated with this discrepancy.
Comment	Text to appear in the Resolution Text field of the DCF report. This field's contents are automatically entered from the CRF Page Number field, provided that the DCF COMMENT TEXTS local reference codelist has an entry for this study, and that entry is not a null string. If you enter your own text in this field, there is no automatic entry made. You can change or delete any entry in this field.

Table 4-6 Maintain Discrepancy Database window: outside of panels

Field	Description
Multi/Single View button	Use this button in the upper right corner of the window to toggle between single-record and multi-record views.
Created By	Identification of the user who created the entry in the discrepancy audit trail.
on	Date discrepancy was created.
Owning Group	When you create a manual discrepancy in the Maintain Discrepancy Database window, the system populates the Owning Group field with the User Group for your discrepancy management profile. For example, if you log into discrepancy management as DM Master Profile, the system records 'DM' as the Owning Group for any manual discrepancies you create; 'DM' is the user group for this profile. The OWNING_GROUP_TYPE_CODE column is also populated when you create a Manual (Field) or a Manual Header discrepancy from RDC HTML Data Entry, and when you create a Manual (Field) discrepancy from OC Data Entry.
Exit	Click this button to: cancel a query, discard changes, or close this window and return to the Data Validation menu path. You receive a prompt to save changes.
Save	Saves your changes to the database. You must click this button after making some group changes in other windows in order to save the changes.
Change Study	Click this button to work on a different clinical study.
Change Profile	Click this button to change your user profile (if you have the necessary privileges). See Selecting a Profile.
View History	Click this button to see the review history of the discrepancy. See Viewing a Discrepancy's History.
Details	Click this button to see further information about univariate discrepancies. See Viewing Univariate Discrepancies' Related Discrepancies.
Add Manual	Click this button to add a manual discrepancy of either type Manual Data Point or Manual Header. See Discrepancy Types.
Multi-record View	(Displayed in single-record view only.) Toggles to multi-record view.
Single-record View	(Displayed in multi-record view only.) Toggles to single-record view.
Group Action on Selected Records	(Displayed in multi-record view only.) Click this button to make group changes to discrepancies, including: updating review status, adding CRF page numbers, inserting standard comment text, marking for passive review, and creating a DCF for the group you select. See Selecting a Group of Records to Change.
Change Layout	(Displayed in multi-record view only.) Click this button to change the display order of discrepancy information or to use as a query filter.