Configuring Role-Specific Discrepancy Management for RDC

You use the reference codelists in Oracle Clinical to define your discrepancy management system for both Oracle Clinical and RDC Onsite.

To configure most settings for your discrepancy management system, you use the installation reference codelists in Oracle Clinical.

To access the installation reference codelists:

1. Open Oracle Clinical.

2. Select Admin, Reference Codelists, and then select Installation Codelists.

See Reference Codelists for general information on setting reference codelist values.

For more information, see:

• Configuring Discrepancy Display by User Role
  
• Configuring the Actions Allowed on Discrepancies
  
• Preventing Update to OTHER Discrepancies
  
• Adding Reference Codelists for Custom Roles
  

Configuring Discrepancy Display by User Role

RDC uses the DISCREPANCY STATUS role installation reference codelists to determine how discrepancies with a particular status are displayed for users with a particular role. There is a different reference codelist for each default user role: CRA, DM, INV, and SITE. You can create a DISCREPANCY STATUS reference codelist for additional roles; see Adding Reference Codelists for Custom Roles.

Use these codelists to ensure that discrepancies are displayed appropriately for users of different roles. 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.

Note:

These reference codelists do not determine what actions a user can perform on discrepancies or their underlying patient data. The DISCREPANCY ACTIONS role codelists determine what routing and resolution actions each user role can take on a discrepancy.

Note:

If you create additional roles for use in discrepancy management you must create a new reference codelist called DISCREPANCY STATUS role for each of them and set it up the same way that these reference codelists are set up.

Every status defined in the DISCREPANCY REV STATUS CODE codelist must be included in the DISCREPANCY STATUS role codelist for each role, with a long value that determines how the discrepancy is presented (or not) to the user. The possible long values are:

• ACTIVE: (For open discrepancies) The current user can take action against this discrepancy.

• OTHER: (For open discrepancies) The discrepancy is assigned to a user with a different role. For RDC Onsite, you can prevent users from taking action on OTHER discrepancies with the reference codelist DISCREPANCY NO OTHER UPDATE; see Preventing Update to OTHER Discrepancies.

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

• HIDDEN: (For open discrepancies) The current user cannot view or take action against this discrepancy. This functionality is intended only for section-type discrepancies. If a 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.

  There is another technique for hiding any type of discrepancy (section, univariate, multivariate) at a particular status (for example Internal DM Review) from a particular user role (for example SITE). In this example, simply uncheck the Active check box for the status Internal DM Review in the codelist DISCREPANCY STATUS SITE.

  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.

  Note:

  Long values must be in uppercase.

For more information, see:

• How RDC Indicates Discrepancies in the User Interface
  
• Rules for the DISCREPANCY STATUS role Codelists
  
• Comparison of the Default Values for the DISCREPANCY STATUS role Codelists
  
• DISCREPANCY STATUS CRA
  
• DISCREPANCY STATUS DM
  
• DISCREPANCY STATUS INV
  
• DISCREPANCY STATUS SITE
  

How RDC Indicates Discrepancies in the User Interface

RDC uses the settings of these codelists to indicate to the current user whether a CRF, patient, or individual response is associated with a discrepancy and if so, whether it is a discrepancy that requires action by the current user. The table below describes the colors that RDC uses for this purpose. RDC uses these colors to highlight the patient icon, the CRF icon, and the individual fields in a CRF that have one or more discrepancies.

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.

Table 3-15 Colors Used to Indicate Discrepancy Access Status

Color	Access Status	Implication
Red	ACTIVE	The CRF contains at least one open discrepancy that requires attention by the user role to which the current user is assigned.
Yellow	OTHER	The CRF contains only open discrepancies that require the attention of a user role different from the one to which the current user is assigned.
White	CLOSED	The CRF contains no visible open discrepancies. Three conditions may be true for a white CRF or patient icon: The CRF may contain discrepancies that are hidden from the current user's user role. The CRF may have contained discrepancies at one time, but all discrepancies are closed or obsolete. The CRF never had any discrepancies.

Rules for the DISCREPANCY STATUS role Codelists

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).

• 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.

• Do not change any long value with a default value of CLOSED.

  Note:

  RDC Onsite uses these reference codelist values.

• 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, use of the text string 'HIDDEN' only works for hiding section discrepancies. The technique of unchecking the Active check box can be used to hide any type of discrepancy: section, manual field, univariate, or multivariate.

• 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 Onsite 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.

Comparison of the Default Values for the DISCREPANCY STATUS role Codelists

The following table provides a comparison of how each default discrepancy status is displayed by default for each user role.

Table 3-16 User Roles and the Default RDC Onsite Discrepancy Access Statuses

Short Value – Oracle Clinical Discrepancy Review Status	Long Value – RDC Onsite Display CRA	Long Value – RDC Onsite Display DM	Long Value – RDC Onsite Display INV	Long Value – RDC Onsite Display SITE
UNREVIEWED	ACTIVE	ACTIVE	ACTIVE	ACTIVE
CRA REVIEW	ACTIVE	OTHER	OTHER	OTHER
INV REVIEW	OTHER	OTHER	ACTIVE	OTHER
DM REVIEW	OTHER	ACTIVE	OTHER	OTHER
TMS EVALUATION	OTHER	OTHER	OTHER	OTHER
TMS IN PROGRESS	OTHER	OTHER	OTHER	OTHER
RESOLVED	CLOSED	CLOSED	CLOSED	CLOSED
IRRESOLVABLE	CLOSED	CLOSED	CLOSED	CLOSED
CLOSED	CLOSED	CLOSED	CLOSED	CLOSED
INT CRA REV	ACTIVE	OTHER	HIDDEN	HIDDEN
INT DM REV	OTHER	ACTIVE	HIDDEN	HIDDEN
INT RESOLVED	CLOSED	N/A	CLOSED	CLOSED

DISCREPANCY STATUS CRA

This codelist contains discrepancy status groupings for the CRA role.

Table 3-17 Values for the DISCREPANCY STATUS CRA Reference Codelist

Seq	Short Value	Long Value	Active Check Box
1	UNREVIEWED	ACTIVE	Y
2	CRA REVIEW	ACTIVE	Y
3	INV REVIEW	OTHER	Y
4	DM REVIEW	OTHER	Y
5	TMS EVALUATION	OTHER	Y
6	TMS IN PROGRESS	OTHER	Y
7	RESOLVED	CLOSED	Y
8	IRRESOLVABLE	CLOSED	Y
9	CLOSED	CLOSED	Y
10	INT CRA REV	ACTIVE	Y
11	INT DM REV	OTHER	Y

DISCREPANCY STATUS DM

This codelist contains discrepancy status groupings for the Data Management role.

Table 3-18 Values for the DISCREPANCY STATUS DM Reference Codelist

Seq	Short Value	Long Value	Active Check Box
1	UNREVIEWED	ACTIVE	Y
2	CRA REVIEW	OTHER	Y
3	INV REVIEW	OTHER	Y
4	DM REVIEW	ACTIVE	Y
5	TMS EVALUATION	OTHER	Y
6	TMS IN PROGRESS	OTHER	Y
7	RESOLVED	CLOSED	Y
8	IRRESOLVABLE	CLOSED	Y
9	CLOSED	CLOSED	Y
10	INT CRA REV	OTHER	Y
11	INT DM REV	ACTIVE	Y

DISCREPANCY STATUS INV

This codelist contains discrepancy status groupings for the INVESTIGATOR role.

Table 3-19 Values for the DISCREPANCY STATUS INV Reference Codelist

Seq	Short Value	Long Value	Active Check Box
1	UNREVIEWED	ACTIVE	Y
2	CRA REVIEW	OTHER	Y
3	INV REVIEW	ACTIVE	Y
4	DM REVIEW	OTHER	Y
5	TMS EVALUATION	OTHER	Y
6	TMS IN PROGRESS	OTHER	Y
7	RESOLVED	CLOSED	Y
8	IRRESOLVABLE	CLOSED	Y
9	CLOSED	CLOSED	Y
11	INT CRA REV	HIDDEN	Y
12	INT DM REV	OTHER	Y
11	INT RESOLVED	CLOSED	N

DISCREPANCY STATUS SITE

This codelist contains discrepancy status groupings for the SITE role.

Table 3-20 Values for the DISCREPANCY STATUS SITE Reference Codelist

Seq	Short Value	Long Value	Active Check Box
1	UNREVIEWED	ACTIVE	Y
2	CRA REVIEW	OTHER	Y
3	INV REVIEW	OTHER	Y
4	DM REVIEW	OTHER	Y
5	TMS EVALUATION	OTHER	Y
6	TMS IN PROGRESS	OTHER	Y
7	RESOLVED	CLOSED	Y
8	IRRESOLVABLE	CLOSED	Y
9	CLOSED	CLOSED	Y
10	INT CRA REV	HIDDEN	Y
11	INT DM REV	HIDDEN	Y
12	INT RESOLVED	CLOSED	N

Configuring the Actions Allowed on Discrepancies

In RDC Onsite, a user changes the review status of a discrepancy by selecting an option from the list in the Action field. You use the DISCREPANCY ACTIONS role codelists to define the set of routing and resolution actions that each user role can take against discrepancies with a particular status.

Only RDC uses the set of DISCREPANCY ACTIONS role codelists. You can create a DISCREPANCY ACTIONS reference codelist for additional roles; see Adding Reference Codelists for Custom Roles.

Note:

RDC disallows routing of all but section discrepancies to a HIDDEN status as follows: 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 (that is, has a long value of HIDDEN in the DISCREPANCY STATUS role codelist) for any role.

However, the same restriction does not apply if you use the alternative method for hiding discrepancies from one or more user roles. That is, simply uncheck the Active check box in the DISCREPANCY STATUS role codelist for the 'blinded' user role.

To enable users of the relevant role to route discrepancies to a particular status:

1. In the Short Value field, enter the name of the discrepancy status—as it appears in the DISCREPANCY REV STATUS CODE codelist—to which you want users of the role specified in the reference codelist name to be able to route discrepancies.

   Note:

   The codelist must contain one and only one row with 'CLOSED' as a short value.

2. In the Long Value field, enter the Actions drop-down item text that should appear for users with the role.

3. Be sure the Active check box is checked.

   Note:

   To remove the item from the Actions drop-down list, uncheck the Active check box.

   The Description field is optional.

4. Save your work.

Each DISCREPANCY ACTIONS role codelists specifies allowed actions for one of the default user roles:

• Rules for the DISCREPANCY ACTIONS role Codelists
  
• DISCREPANCY ACTIONS CRA
  
• DISCREPANCY ACTIONS DM
  
• DISCREPANCY ACTIONS INV
  
• DISCREPANCY ACTIONS SITE
  

Rules for the DISCREPANCY ACTIONS role Codelists

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 Onsite 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 Onsite displays this text in the Action drop-down list.

DISCREPANCY ACTIONS CRA

This codelist contains discrepancy actions for the CRA role. The initial short and long values are:

Table 3-21 Values for the DISCREPANCY ACTIONS CRA Reference Codelist

Seq	Short Value	Long Value	Description
1	DM REVIEW	Null	Send to Data Mgt
2	RESOLVED	IRRESOLVABLE	Closed - Resolved
3	IRRESOLVABLE	IRRESOLVABLE	Irresolvable
4	INT DM REV	Null	Internal Data Mgt review

DISCREPANCY ACTIONS DM

This codelist contains discrepancy actions for the DATA MANAGER role. The initial short and long values are:

Table 3-22 Values for DISCREPANCY ACTIONS DM Reference Codelist

Seq	Short Value	Long Value	Description
1	INT REVIEW	Null	Send to site
2	TMS REVIEW	Null	Send for classification
3	RESOLVED	IRRESOLVABLE	Closed - Resolved
4	IRRESOLVABLE	IRRESOLVABLE	Irresolvable
5	INT CRA REV	Null	Internal CRA review

DISCREPANCY ACTIONS INV

This codelist contains discrepancy actions for the INVESTIGATOR role. The initial value is:

• DM REVIEW — Send to Data Mgt

DISCREPANCY ACTIONS SITE

This codelist contains discrepancy actions for the SITE role. The initial value is:

• DM REVIEW — Send to Data Mgt

Preventing Update to OTHER Discrepancies

Only RDC Onsite uses the DISCREPANCY NO OTHER UPDATE installation codelist.

You can use the DISCREPANCY NO OTHER UPDATE codelist to specify which user roles do not have access to and cannot update discrepancies that appear to them with a status of OTHER; see Configuring Discrepancy Display by User Role.

By default, the DISCREPANCY NO OTHER UPDATE codelist has no values. All users can update discrepancies with a status of OTHER. To prevent users from updating OTHER discrepancies, you add one or more user roles to the codelist.

To prevent users with a particular role from updating OTHER discrepancies:

1. Open the DISCREPANCY NO OTHER UPDATE codelist.

2. Enter the role name in the Short Value field. The value you enter must be exactly the same as one of the long values in the USER GROUP ROLES reference codelist. For example, CRA, INV, or SITE.

   Caution:

   The system does not check the validity of your entries. You must be careful to specify only valid user roles. If the values do not match exactly, users with the role will still be able to update OTHER discrepancies.

3. Select the Active check box. An active entry indicates the user role cannot update OTHER discrepancies.

4. Save your work.

The Seq, Long Value, Default, and Description fields are not used by RDC Onsite.

You can grant this privilege to any number of roles.

To allow the update of OTHER discrepancies for a role that you added to the DISCREPANCY NO OTHER UPDATE codelist, you can either:

• Delete the record by using the command on the Data menu.

• Make the value inactive by clearing its Active check box.

Adding Reference Codelists for Custom Roles

Oracle Clinical ships with Discrepancy Actions and Discrepancy Status reference codelists for these roles: DM, CRA, INV, and SITE. If you have defined additional roles, you can create additional Discrepancy Actions and Discrepancy Status reference codelists for these roles.

Note:

To create a custom role, create a new database role and map it to a User Group Role; see Creating and Modifying Database Roles and USER GROUP ROLES Installation Codelist.

Log in to SQL*Plus as RXC and run a script that includes the following statements to create a new Discrepancy Actions and a new Discrepancy Status reference codelist for your custom role:

exec opa_install.insertrc('DISCREPANCY ACTIONS custom_user_group_role', 'Y','60','15','INSTALLATION','CHAR','Discrepancy actions for custom_user_group_role','','','RXC');

exec opa_install.insertrc('DISCREPANCY STATUS custom_user_group_role', 'Y','6','15','INSTALLATION','CHAR','Discrepancy status groupings for custom_user_group_role','','','RXC'); 

The new reference codelists then appear in the Oracle Clinical user interface and you can add appropriate values.