4 Configuring Discrepancy Management

4.2.1 Defining the Reasons for Manual Discrepancies

In RDC, a user can add the following types of manual discrepancies:

• Field discrepancy

• Section discrepancy

When a user adds a manual discrepancy to a CRF, RDC displays the Add Discrepancy dialog box. The user must select a reason for the discrepancy from the list in the Reason field. Optionally, the user can enter additional comments about the discrepancy.

To define the list of reasons for a manual discrepancy, you modify the MANUAL SOURCE TYPE CODE reference codelist in Oracle Clinical. (See Figure 4-1.) For each reason, you enter values into the Short Value field and the Description field.

RDC displays the text you enter in the Description field as the list of reasons that the user can select from when adding a manual discrepancy. Oracle Clinical stores the short value in the database.

The first time the user adds a manual discrepancy during a login session, RDC automatically displays the default reason in the Reason field. The user can select a different reason from the drop-down list. For subsequent manual discrepancies added by the user, RDC displays the last reason the user selected. The user can always select a different reason.

Figure 4-1 Defining the Reasons for a Manual Discrepancy

Description of ''Figure 4-1 Defining the Reasons for a Manual Discrepancy''

4.2.2 Defining the Reasons for Univariate Discrepancies

When a univariate discrepancy is raised, RDC automatically determines which reason to use based on the type of univariate discrepancy. Examples of reasons for univariate discrepancies are DATA TYPE, LENGTH, and MANDATORY.

To define the reasons for univariate discrepancies:  

1. Open Oracle Clinical.

2. Navigate to Admin, Discrepancy Mgmt Admin, and then select Standard Text Maintenance. See Figure 4-2.

Figure 4-2 Defining the Reasons for Univariate Discrepancies

Description of ''Figure 4-2 Defining the Reasons for Univariate Discrepancies''

You use the fields in the Standard Text Maintenance form to describe each type of univariate discrepancy as follows:

• Text Type — Select COMMENT to indicate that this row defines one description for a univariate discrepancy.

• Sub Type — Select from the list of valid types of univariate discrepancies.

• Standard Text Name — Ordinarily, you specify a name to match the Sub Type. However, if you want to specify more than one reason for a discrepancy type, use this field to specify a unique identifier.

• Default — If you specify more than one reason for a certain type of discrepancy, select which reason is the default value. RDC uses the default value the first time a discrepancy of that type is raised. The user can always select one of the alternative reasons provided.

• Standard Text — Specify the description that you want RDC to display for the discrepancy type raised. Note that you can use variables to include the data value of the discrepant response as well as the definitional components of the question.

See the Oracle Clinical Administrator's Guide for details on creating default standard text depending on the type of univariate discrepancy.

4.2.3 Defining the Reasons for Multivariate Discrepancies

Oracle Clinical raises multivariate discrepancies in RDC when Oracle Clinical executes its defined validation procedures. Although you can customize the reason for a multivariate discrepancy, RDC does not display the reason for a multivariate discrepancy.

However, Oracle Clinical does display the reason. For details on how to create and modify procedures to customize the reason description for multivariate discrepancies, see Oracle Clinical Conducting a Study.

4.3.1 Default Entries for the DISCREPANCY REV STATUS CODE Codelist

Table 4-1 lists the entries in the DISCREPANCY REV STATUS CODE installation codelist following the initial installation of Oracle Clinical.

4.3.2 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.

4.4.1 Access Status Values

In each DISCREPANCY STATUS role codelist, the short value defines the discrepancy review status. Recall that every short value in each DISCREPANCY STATUS role codelist must also appear in the DISCREPANCY REV STATUS CODE codelist.

The long value defines the discrepancy access status. The access status determines whether users in a certain role can take action on a discrepancy.

Long values must be in uppercase. Acceptable values for the long value are:

• ACTIVE — The current user can take action against this discrepancy.

• OTHER — The discrepancy requires the attention of a different user role. You can prevent users from taking action on OTHER discrepancies. See Section 4.7, "Preventing Update to OTHER Discrepancies" for more information.

• HIDDEN — The current user cannot view or take action against this discrepancy.

  This functionality is intended only for section-type discrepancies. At run time, if the user selects a univariate or multivariate discrepancy, the Action drop-down list excludes any action that would route the discrepancy to a status that is HIDDEN for any role.

  Note:

  If you change the long value to HIDDEN for a status that has already been applied to univariate or other types of discrepancies, these existing discrepancies are hidden to users with the relevant role, even though only section discrepancies are intended to allow hiding.

• CLOSED — If the discrepancy was manually closed by a user, any user with UPDATE or UPD_DISCREP privilege can re-open the discrepancy. System-closed discrepancies cannot be re-opened.

Note that the discrepancy access status does not determine what functions a user can perform on the discrepancy or the patient data. The DISCREPANCY ACTIONS role codelists determine what routing and resolution actions each user role can take on a discrepancy.

4.4.2 Colors Used to Indicate Discrepancy Access Status

Table 4-2 describes the colors that RDC uses to indicate the status of the discrepancies, if any, in a CRF. RDC uses these colors to highlight the patient icon, the CRF icon, and the individual fields in a CRF.

Note that:

• HIDDEN discrepancies are not highlighted in any color because they are not visible to particular user roles.

• RDC uses green to highlight the fields in a CRF that have a discrepancy that was manually closed by the user. Fields with a system-closed discrepancy are not highlighted.

4.4.3 Default Entries for the DISCREPANCY STATUS role Codelists

The access status depends upon the current user's user role and upon how you configure each review status to appear to that user role. For example, a discrepancy with a review status of Under CRA Review should appear as ACTIVE to a CRA, but as OTHER to an investigator.

Table 4-3 lists the entries for the DISCREPANCY STATUS role codelists for the default user roles.

If you combine the information in Table 4-2 and Table 4-3, you can find how a user assigned the DM role sees a discrepancy of review status DM REVIEW with a red highlight (ACTIVE), while a user assigned the SITE role sees the same discrepancy with a yellow highlight (OTHER).

4.4.4 Rules for the DISCREPANCY STATUS role Codelist

When entering and modifying values in a DISCREPANCY STATUS role codelist, you must follow these rules:

• Each DISCREPANCY STATUS role codelist must include all short values that appear in the DISCREPANCY REV STATUS CODE codelist, and must not contain any values not in that codelist. When you add a short value to one codelist, you must add the same short value to the other codelist. (An exception is the CLOSED status, described below).

  You then use the Active check box to enable and disable the review status for a user role.

• Each codelist must contain the short value CLOSED, which has a corresponding long value CLOSED. This is the status that is used for any system-resolved discrepancy, that is, a data discrepancy that was resolved as the result of an update to a non-discrepant value.

• The RESOLVED and IRRESOLVABLE short values must have a long value of CLOSED for all roles.

• If a review status is CLOSED for one user role it must be either CLOSED or HIDDEN for all other user roles. Note also that for any review status that appears as CLOSED in a DISCREPANCY STATUS role codelist, the DISCREPANCY REV STATUS CODE codelist must represent the review status with a long value of IRRESOLVABLE.

• The setting of the Active check box determines whether discrepancies of that status are visible to users with the relevant role. If the Active check box is not selected, users with the role cannot see discrepancies of that status. If the Active check box is selected, users with the role can see discrepancies of that status. The way discrepant values are displayed depends on the long value.

  Note:

  Either disabling the Active check box or setting the long value to HIDDEN has the effect of hiding discrepancies of the relevant status from users with the relevant role. However, to ensure compatibility with future releases and to avoid confusion between the two settings, Oracle recommends that you use the Active check box to hide discrepancies. In addition, the Active check box lets you hide all types of discrepancies (section, manual field, univariate, or multivariate). The HIDDEN value lets you hide section discrepancies only.

• If an entry in a DISCREPANCY STATUS role codelist is active, then the corresponding entry in the DISCREPANCY REV STATUS CODE codelist must also be active. If not, the discrepancy configuration is invalid. RDC will display an error message to alert users to the problem.

• The Description field is optional for all entries.

• The setting of the Default check box has no effect. The default status of a new discrepancy is always UNREVIEWED.

4.5.1 Default Entries for the DISCREPANCY ACTIONS role Codelists

Table 4-4 lists the default entries for the DISCREPANCY ACTIONS DM codelist, which defines the allowed actions for the Data Manager (DM) user role.

4.5.2 Rules for the DISCREPANCY ACTIONS role Codelist

When entering and modifying values in a DISCREPANCY ACTIONS role reference codelist, you must follow these rules:

• Each DISCREPANCY ACTIONS role codelist must contain a subset of the short values (the statuses) defined in the DISCREPANCY REV STATUS CODE codelist. The long value specifies an action that the user can take against a discrepancy. The corresponding short value, which must match a short value in the DISCREPANCY REV STATUS CODE codelist, identifies the status RDC assigns to the discrepancy when the user selects the action.

• CLOSED should not appear as a short value in any DISCREPANCY ACTIONS role codelist.

• You must specify text in the Long Value field. RDC displays this text in the Action drop-down list.

• The Description field is optional for all entries.