Mapping Database Roles to User Roles

This section applies to all RDC users and to Oracle Clinical users who need to work with discrepancies in Oracle Clinical's Maintain Discrepancy Database window.

User roles are important because:

• RDC uses them to define access privileges; see the Oracle Clinical Remote Data Capture Onsite Administrator's Guide for more information.
• You can customize RDC discrepancy management, news, and activities for different user roles; see the Oracle Clinical Remote Data Capture Onsite Administrator's Guide for more information.
• You can customize the layout of the Maintain Discrepancy Database window for different roles; see Customizing Layout Definitions.
• You can customize profiles for different roles; see Customizing Profiles.

For these customizations and access privileges to be available to a user, the user must have a database role that is mapped to the relevant user role in the User Group Roles installation reference codelist.

There are five default user roles. You can create additional roles if necessary, and map them in the User Group Roles reference codelist to make them available for customizing features in RDC and Oracle Clinical discrepancy management; see Creating Custom Database Roles.

The following table shows the default mapping of database roles to user group roles. The Long Value is not used.

Table 3-1 Default Values for the USER GROUP ROLES Codelist

Database Role (Short Value)	User Group Name (Long Value)	Description
RXC_DMGR	DM	Data management role
RXC_SUPER	DM	Data management role
RXC_CRA	CRA	CRA role
RXC_SITE	SITE	Site user
RXC_BIOS	BIOSTAT	Biostatistics role
RXC_QC	QUALITY CONTROL	Quality control role
RXC_INV	INV	Investigator

Note:

The USER GROUPS reference codelist is used in Oracle Clinical discrepancy management only. It contains a subset of the User Group Roles in the USER GROUP ROLES reference codelist and determines which of them are available for use in Oracle Clinical discrepancy management; see Configuring Discrepancy Management

For more information, see:

• Specifying User Roles for the Oracle Clinical Discrepancy Database
  
• Assigning Function Privileges and Layouts
  

Specifying User Roles for the Oracle Clinical Discrepancy Database

In the USER GROUPS installation reference codelist, you specify which of the roles mapped to database roles in the USER GROUP ROLES reference codelist will be available for use in customizing aspects of the discrepancy management system in Oracle Clinical, including profiles and layouts for use in the Maintain Discrepancy Database window.

The position of a database role in the codelist is important if users have more than one database role. In the case of a user with more than one role, the system uses the database role closest to the top (seq=1) in the codelist as the default; for example, as the default profile when the user opens the Maintain Discrepancy Database window.

The long value is not used.

Table 3-2 Default Values for the USER GROUPS Codelist

Seq	Short Value (Database Role)	Long Value (User Group Name)	Description
1	DM	—	Data managers
2	CRA	—	Clinical research associates
3	BIOSTAT	—	Biostatistics group
4	QUALITY CONTROL	—	Quality control department

Note:

User groups is a misleading term here. This codelist is used only in discrepancy management (including data clarification forms). The term used for groups of users who have access to the same studies, programs, or projects is group user account.

Assigning Function Privileges and Layouts

You control user group discrepancy function privileges and layout definitions in the User Group Admin window. From the Admin menu, select Discrepancy Mgmt, then select User Group Administration.

The window displays a list of existing user group names and their mapped database roles. Select a user group name to view its defined function privileges and layouts.

For more information, see:

• Assigning and Removing Function Privileges
  
• Assigning Custom Layouts
  

Assigning and Removing Function Privileges

In the Function Privileges display, you can add or remove privileges for the selected user group. If a group lacks a particular privilege, the system prevents members of that group from performing the function. (The system reference codelist DISCREPANCY FUNCTIONS controls the list of values; you cannot modify it.)

To add a privilege:

1. Click in an empty row. An ellipsis (…) appears.

2. Click the ellipsis. The list of values appears.

3. Select a privilege and click OK. The system adds the privilege.

To remove a privilege, select it and then select Delete Record from the Data menu.

The following table describes the function privileges.

Table 3-3 Function Privileges for Discrepancy Management

Name	Privilege Granted and Method of Use
UPD DATA ENTRY	Enables the Update Patient Data Special menu item in the Discrepancy Database window, and allows updates while in the Data Entry subsystem.
BRWS DATA ENTRY	Enables the Browse Patient Data Special menu item in the Discrepancy Database window for read-only access to patient data.
MANUAL	Enables the Add Manual button in the Maintain Discrepancy Database window, which allows users to create manual discrepancies and manual header discrepancies.
DCF PRINT DRAFT	Displays the Draft option in the DCF Print Options window; enables the user to print a draft version of a Data Clarification Form (DCF) report.
DCF PRINT COPY	Enables the Copy option in the DCF Print Options window; enables the user to print a copy of a DCF.
DCF PRINT FINISH	Enables the Final option in the DCF Print Options window; enables the user to print a final version of a DCF report.
DCF REPRINT	Enables the Reprint option in the DCF Print Options window; enables the user to reprint a final version of a DCF report.
CREATE DCF	Enables the Create DCF option in the group selection menu in the Maintain Discrepancy Database form.

Assigning Custom Layouts

If you define one or more custom layouts for the Discrepancy Database window (see Customizing Layout Definitions, assign it to a user group to allow the user group to use it. Users can select the layout they want to use from the User Group Layouts item in the Special menu of the Discrepancy Database window.

To assign a layout to a user group:

1. Click in an empty row. An ellipsis (…) appears.

2. Click the ellipsis. The list of values appears.

3. Select a layout and click OK. The system adds the layout.

To remove a layout, select it and then select Delete Record from the Data menu.