| Oracle® Argus Safety Administrator's Guide Release 6.0.1 E15950-03 |
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PDF · Mobi · ePub |
| Oracle® Argus Safety Administrator's Guide Release 6.0.1 E15950-03 |
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PDF · Mobi · ePub |
The Access Management section enables the Administrator to add, copy or delete users, groups or sites in the system.
Each user must be assigned to at least one group in order to determine their security level. Each group is assigned a specific security level. This security level enables members of the group to view, modify, or restrict access rights to various sections of the Case Form, etc.
The first set of steps in configuring Argus safety is to create the following exactly in the listed order:
User Sites
User Groups
User Accounts
Note:
The configuration must occur in the exact order specified above.Addition of user sites is necessary in order to create User Accounts because every user must be assigned to exactly one user site. User site information can also be used in automatic numbering of case IDs.
Configuration of the user site is done using the Access Management --> Argus --> Sites section. The following is an illustration of that section.
The following table lists and describes the fields on the screen.
| Field/Control Name | Description |
| Description | Enables the user to enter the description of the site. |
| Abbreviation | Enables the user to enter the abbreviation of the site A 1 to 4 character abbreviation is required for each site. |
| Site Type | Enables the user to select Site Type as Argus or LAM (Local Affiliate Module). |
| Protect Patient Confidentiality - Default | Enables the user to protect or reveal Patient Confidentiality for the specific site. |
| Protect Reporter Confidentiality - Default | Enables the user to protect or reveal Reporter Confidentiality for the specific site. |
| Bulk report By form (Approved reports) - Default | Enables the user to allow/protect availability of the Bulk Reports by Form for the specific site. |
| LAM Site | Enables the user to add LAM sites to the Argus Site would enable user to select and add previously created LAM sites. |
Each user of Argus Safety can be a member of one or more user groups. The access rights of each user group to the menus in the user interface and specific sections of the Case Form can be configured when the group is created.
Configuration of the user site is done using the Access Management-->Argus --> Groups section. The following illustration shows the fields associated with this section.
The system enables users to configure access permissions for the Perceptive application from the Perceptive menu options. The following Perceptive Options are available:
Worklist
Active
Action items
Archive
Reports
Context Matrix
Management
Alerts Triggered
Assessor Statistics Breakdown
Pending Actions
Signal Metrics Report
Pharmacovigilance
Analysis Report
Increased Frequency Report
Patient Exposure Report
Utilities
Configuration
Alert Configuration:
Primary Alert
Secondary Alert
Code List Maintenance
Event Group
Global configuration:
Global Alerting Criteria
Global Stop List
Global Template
Patient Exposure
Workflow
View Audit Log
View Error Log
Change Password
The printout displays all group permissions defined by the administrator.
The following table lists and describes the fields in the Add Group Information section.
| Field/Control Name | Description |
|---|---|
| Group Name | Enables the administrator to enter a unique name for the group. |
| Enables the administrator to add the group email, used for case priority notification and workflow routing notification. | |
| Supervisor Email | Enables the administrator to add the Group's Supervisor Email as applicable. This e-mail address is used to send notifications when the maximum time of a case for a particular workflow state is exceeded. |
| Menus | Lists the different menus and sub menus within a Case Form and enables the Administrator to enable or disable each of them. |
| Case Form | Lists the different sections and sub sections within a Case Form and enables the Administrator to assign the group Modify; View (Read Only); or No Access Rights (not visible) to each area. |
| Advanced Condition |
|
| Listedness Determination - Countries | Enables the administrator to assign Argus users to the group that has the rights to change the listedness determination for licenses originating in the selected countries. |
| Restrictions - Products | Product security limits the number of products that can be viewed in the trade name lookup and non-study cases.
Click the Products checkbox to enable the Select button Click this button to view a security configuration containing a tree view list of available items Select a product family to select all its constituents |
| Restrictions - Studies | Study security limits the number of studies available for selection and the study cases that can be viewed.
Click the Studies checkbox to enable the Select button Click this button to view a security configuration containing a tree view list of available items Select a study family to select all its constituents |
| Default report (LAM only) | This field lists the expedited report forms in the drop-down list. |
This screen helps in capturing User Site information (such as user site description, abbreviated term, site type and LAM site configuration).
Navigate to the Access Management->Argus->Sites section.
Click Access Management->Argus->Sites.
In the left panel, select User Sites. The User Sites are listed in the right panel.
Tip:
You can alternatively click Add New to create a new user site.Use Copy to make an editable copy of an existing user site.
Use Delete to delete a user site.
Select the filtering criterion from the Code Filter List.
Select a User Site and click to view the user site details in the Modify User Site section.
Enter the user site Description.
Enter the user site Abbreviation.
Note:
A maximum four-character abbreviation is required for each user site.Select a Site Type from the drop-down list. For more information on this field, refer to the Field Descriptions.
Note:
Each Argus Safety user must be assigned to exactly one user site.You cannot change the site type from LAM to Central if the current central site has an association with a LAM site, the current site is associated with any user, or the current LAM site has any events assigned to it.
Select the following options as required:
Select the Protect Patient Confidentiality - Default to protect or reveal Patient Confidentiality for this specific user site.
Select the Protect Reporter Confidentiality - Default to protect or reveal Reporter Confidentiality for this specific user site.
Select the Bulk Report by Form (Approved Reports) to protect availability of the Bulk Reports By Form for this specific site.
Add or remove any LAM Sites information.
Tip:
To add more LAM Sites to the Lam Sites list, use the Add>>/ Add All options.To delete the LAM Sites from the Lam Sites list, use the Remove>>/Remove All options.
Click Save to save the information and return to the Code List Maintenance dialog.
The filtering criterion is essential as it helps you to search for specific items. The Argus Console provides this option for the Access Management section. The filtering browser is displayed as the Code Filter List
Argus Console helps you to filter information further for the Access Management section. Using the Code Filter List you can specify whether your search should contain or start with specific alphabets.
For Example: The following filtering criteria enables the system to search for all User Sites that contain A in the abbreviated term.
Description of the illustration filter.gif
The right panel now displays the list of User Sites based on the filtering criterion.
This section enables the Administrator to configure the security levels for each work group.
Radio buttons enable you to view the group and assign access rights for several specific sections of the case form, menu, case workflow, and report workflow.
If a user belongs to multiple groups, the access rights for the user will be the sum-total of the individual group access rights. Consider the following example:
John Smith is an Argus User and his profile has been added to 2 user-groups with different access level permissions for each group.
John has access rights to the Patient Tab in one group and access rights to the General Tab in another group.
In this case, John will be able to access both the Patient and the General tabs of Argus
Click Access Management->Argus->Groups.
Select the filtering criterion to display the list of Groups or Users in the left panel.
Select a Group and click to view the group details in the right panel.
Tip:
You can alternatively click Add Group to create a new group.
Use Copy to make an editable copy of an existing group.
Use Delete to delete a group.
Enter the Group Name. This should be a unique name associated with this Group.
Enter the Email address, if applicable.
Enter the Supervisor Email address, if applicable.
In the Case Form section, select the desired access right option ("Modify", "View", or "No Access") for the group's access to each of the listed items of Case Form.
Note:
The following fields are required in order to save a case: Initial Receipt Date, Country of Incidence, Report Type, Suspect Product, and Event Description as Reported. Therefore, the group responsible for initial case entry must have access to these fields in order to save new cases.In the Menus section, enable or disable access of the group, to particular items in the Argus Safety menu.
Tip:
Refer to the Argus Safety User Guide for information about the functions of the Case Form sections and the menu items in the Argus Safety user interface.In the Listedness Determination section, select a list of countries. This enables the end user to override the listedness determination in the Event Assessment section of the Case Form for product licenses that match the countries selected in this step.
In the Advanced Conditions section, select No Create Advanced Condition Access, No Access to Share Advanced Conditions, and/or No Access to View and Edit SQL.
Tip:
If you select the No Create Advanced Condition Access checkbox, the Advanced Conditions button will not appear as an option for that user group.
If you select the No Access to Share Advanced Conditions checkbox, the user group will not have access to share Advanced Conditions.
If you select the No Access to View and Edit SQL checkbox, the SQL... button will not appear as an option for that user group.
In the Restrictions section, select Products.
Click Add Product, to open the Available Products dialog box.
Click the checkbox associated with each product you want to add and click OK.
In the Restrictions section, select Study.
Click Add Study, to open the Available Studies dialog box.
Click the appropriate checkboxes to select the required studies and click OK. 
Description of the illustration studies.gif
Click OK to save the group.
The following table lists and describes the groups included with the factory data.
| Group | Description |
|---|---|
| Administrator | This group has access rights to all areas and all the functionality of Argus Safety. |
| Investigator | Receives an e-mail alert that can be set up during Clinical Study Configuration. |
The filtering criterion is essential as it helps you to search for specific items. The Argus Console provides this option for the Access Management section.
The system displays the filtering browser in the top-left corner of the left panel. You can filter based on either of the two combination shown in the following illustration.
Description of the illustration browser.gif
Consider the following.
If you enable Organized by Groups, the generated output displays in a tree-format in the left panel. The structure is based on the entire categorization of Groups and Users
If you enable the Organized by Users, only the User list is available in the tree view in the left panel.
Using contains or starts with enables you to specify whether your search should contain or start with specific alphabetic characters. For example, filtering criterion shown in the following illustration enables the system to for all Groups that contain the word "administrator."
The system enables you to print a user group.
Select Access Management->Argus->Groups.
Select the filtering criterion to display the list of Groups or Users (based on the filtering criterion) in the left panel.
Select a Group and click to view the group details in the right panel.
Click Print to display a Print dialog that enables the user to choose to print the entire window or to print only the text covered by the current selection.
Select the appropriate options and click OK.
The system opens the Print Groups to enable the user select the sections to be printed in the Group Configuration printout.
By default, the Group Information checkbox is selected and disabled so that it always gets printed.
Select the appropriate checkboxes, and click OK 
Description of the illustration printgroups.gif
The following is an illustration of the Group Configuration printout.
It lists the users which are configured to the groups.
In the report section, users are sorted alphabetically by User Full Name
The filtering criterion is essential as it helps you to search for specific items. The Argus Console provides this option for the Access Management section.
The system displays the filtering browser in the top-left corner of the left panel. You can filter based on either of the two combinations.
Consider the following.
If you enable Organized by Groups, the generated output displays in a tree-format in the left panel. The structure is based on the entire categorization of Groups and Users
If you enable the Organized by Users, only the User list is available in the tree view in the left panel.
Using contains or starts with enables you to specify whether your search should contain or start with specific alphabetic characters. For example, filtering criterion enables the system to search for all Groups that contain the word "administrator."
The User Maintenance Dialog enables the Administrator to add, copy, or delete users for the system.
Each user must be assigned to at least one group in order to determine his/her security level.
Each group is assigned a specific security level that defines whether group members can view, modify, or have no access rights to various sections of the case form, etc.
Configuration of the users is done using the Access Management->Argus->Users section. You can specify a password when creating or modifying an individual user account. When updating user records, be aware of the following:
If you enter a value in the Password field, the system uses this password to authenticate the user when he/she logs in.
The Reset Password field is available only when you have checked the Reset Password check box. The new password can be up to 30 characters.
If you leave the value blank, the system uses default password as defined in the Common Profile for the system.
When you save the user configuration, the system saves the default password you entered.
During entry, the system displays the password the user types.
The password update function is included in the Argus Insight and Perceptive modules.
The user can grant access to the AC Admin. The default is unchecked.
Click in the AC Admin check box to grant access. This also grants access to the Reassign button on the Advanced Conditions Library screen.
The User Maintenance report prints the options.
The following illustration shows the fields associated with this section.
The following table lists and describes the fields in the Administrator section
| Field/Control Name | Description |
|---|---|
| User Name | Enables the administrator to enter the user's full name. |
| User ID | Each Argus user must have a unique username. The system checks the username to verify that it is unique |
| Reset Password | Enables the Administrator to reset the password of a user to a default value specified in the common profile section. |
| Email Address | Enables the Administrator to enter the user's e-mail address. |
| User Type | Enables the administrator to select the type of user account as:
|
| Site | Enables the Administrator to assign the user to a site.
The values in this field are populated from the codelist item User Sites'. |
| User Group - Select | Enables the administrator to attach the user to pre-configured user groups. |
| Application Access | Enables the administrator configure user access settings for Argus Console and Argus.
The default application access for the user can be selected from the drop-down list box. |
| Worklist to display at login | Enables the administrator to configure user to see user's worklist immediately upon login. The options available in the drop down shall be:
None (default) - Does not open any worklist when the user logs into Argus. Displays personal Argus status on login.
|
| Workflow manager | Checking the Workflow manager gives the user more rights within the system
|
| Enterprise | Enables administrators to configure a workflow manager user as an enterprise user.
If Enterprise is checked, the user can view cases of any site outside its site |
| Enable site security | If Enable Security is checked, the site-based data security will be enabled for the user.
If the box is not checked the user will have full access to data from all sites. |
| Enable LDAP Login | Enables the user to be authenticated against the active directory server.
When checked, the system disables the following fields on the user configuration screen:
|
| Account Disabled | When this option is selected, the user account is temporarily disabled to prevent users from logging in. This option is different from deleting a user as it enables the Administrator to re-activate the account at a later date. |
| Security Disabled Account |
|
| ESM Admin | When checked, this enables the user to access the ESM Mapping utility |
| Force password change at login | If this check box is selected, the users must change the password the first time user logs on to the system after the checkbox is checked. |
| Force password to expire every | Enables the Administrator to force the user's password to expire in the specified number of days. |
| Days | Enables the Administrator to enter the number of days after which the password should expire. |
| __ Days remaining | The field displays the number of days remaining for the password change. |
| Allow unblinding of cases | Enables the user to unblind a study case.
For example, a user without unblinding rights will not see the Study Drug field. A user with unblinding rights sees a yellow Unblind tag next to concentration of product field and the Broken by Sponsor option in Blinding Status drop-down list is enabled. User will have to enter password when user selects the "Broken by Sponsor" option. |
| Protect from unblinded information | When checked, the user cannot view any unblinded information. |
| Protect from printing unblinded information | When checked, the user cannot print any unblinded information. |
| Allow locking of cases | Enables the user, to lock/unlock the cases. |
| Allow closing of cases | Enables the user to close the cases. |
| Route on close case | When checked, this disables the case routing dialog which appears when the users selects Case Actions - close case on the case form. |
| Enable Checklist on Route | By default, this checkbox is selected.
If this checkbox is not selected, the checklist for the Workflow is not displayed to the user while routing the cases, even if the rule that is being used has a checklist. |
This section enables you to add, copy, modify or delete users for the system. When adding users, be aware of the following:
Each Argus user must be assigned to at least one group in order to determine his/her security level.
Each group is assigned a specific security level. The security level determines whether the group members can view/modify or have limited access rights to various sections of the case form, etc.
Select Access Management then Argus and then click Users.
Select the filtering criterion. The left panel now displays the list of Groups or Users based on the filtering criterion.
Select a User and click to view the user details in the right panel.
Tip:
You can alternatively click Add User or Add New User to create a new user.
Use Copy to make an editable copy of an existing user.
Use Delete to delete a user.
Enter the User Name. This should be a unique name associated with this user.
Enter the User Id. This is the unique user name associated with the user.
Enter the Email Address of the user.
Select the Site from the drop-down list. The user is assigned to this site.
Select the User Type from the drop-down list.
Tip:
The options that appear on this screen change with the configuration settings available for each User Type. For example for AG Service User Type, you can configure the Access password from this screen itself.Select the language from the drop-down list in Modify Language Narrative.
This is the language for which the user has access to in the multi-lingual fields.
Select the following options in Access, as required.
| Field/Control Name | Description |
| Account Disabled | Enables the administrator to disable the account. |
| Security Disabled Account | Enables the administrator to disable the account depending upon the number of consecutive unsuccessful login attempts.
|
| ESM Admin | Enables the administrator to give the Argus user access to the ESM Mapping utility. |
| Force Password change at login | Ensures that password is changed at login.
Select this field to force Argus users to change their password, when they log in to the application for the first time. |
| Force password to expire every days | Enter the maximum number of days for the user(s) to retain user password. |
| Reset Password | Select this field to reset the user password. |
Select the following options in Case Form, as per your requirements.
| Field /Control Name | Description |
| Allow unblinding of Cases | Select this to enable the user to unblind a study case.
|
| Protect from unblinded information | Enables the Administrator to protect a user from unblinding information such as Study Drug, Concentration, Dosage Regimens and Total Dosage. |
| Protect from printing unblinded information | Select this to disable the user from printing unblinded information. |
| Allow locking of cases | Select this to enable the user to lock cases. |
| Allow closing of cases | Select this to enable the user to close cases. |
| Route on Close Case | Select this to disable the case routing dialog which appears when the users selects Case Actions - Close Case on the case form. |
Select the User Group, using Select.
Enable the Application Access for different Oracle applications such as Argus or Console.
Select the Default application access from the drop-down list, for the user.
Select the default worklist to be displayed on logging onto Argus from the Worklist to display at login drop-down list, for the user.
Select the Workflow manager check box to give the user more rights within the system.
Select the Enterprise check box to configure a 'Workflow Manager' user as an 'Enterprise user'. The user can view cases of any site outside its site too. This field is enabled only when the 'Workflow Manager' field is checked.
Select the Enable Site Security checkbox to enable site based security data for the user.
This is made possible through the Site Access Configuration dialog.
The Site Access Configuration section enables a user to get access to additional sites.
Description of the illustration worklist.gif
The administrator can select the access level by selecting from the options available in this dialog.
The following table describes the access levels in this dialog:
| Authorizations | ||||
|---|---|---|---|---|
| Site Access Level | Data Access | Function Access | Summary Reports | Workflow |
| No Access | No | None | No | No |
| View | Read Only | Defined by sum of user-group membership | Yes | Yes |
| Full | Read / Write | Defined by sum of user-group membership (Stipulated by - All - in the user group section) | Yes | Yes |
| Single Group | Read / Write | Defined by single user-group | Yes | Yes |
Select the Enable LDAP Login check box to enable the user to be authenticated against the active directory server.
The filtering criterion is essential as it helps you to search for specific items. The Argus Console provides this option for the Access Management section.
The system displays the filtering browser in the top-left corner of the left panel. You can filter based on either of the two combinations.
Consider the following.
If you enable Organized by Groups, the generated output displays in a tree-format in the left panel. The structure is based on the entire categorization of Groups and Users
If you enable the Organized by Users, only the User list is available in the tree view in the left panel.
Using contains or starts with enables you to specify whether your search should contain or start with specific alphabetic characters. For example, filtering criterion enables the system to for all Groups that contain the word "administrator."
The system enables you to print a user group.
Select Access Management then Argus and then Groups.
Select the filtering criterion. The left panel now displays the list of Groups or Users based on the filtering criterion.
Select a User and click to view the user details in the right panel.
Click Print to display the Print dialog. This enables the user to select whether print the entire window or to print only the text for the current selection.
Select the appropriate option and click OK.
The system opens the Print Users dialog to enable the user to select the sections to print in the User Configuration printout.
By default, the User Information check box is selected and disabled so that it always gets printed.
Select the appropriate check boxes, as required and click OK
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