6 Managing Roles

This chapter contains the following topics:

Section 6.1, "Managing InForm Roles"
Section 6.2, "Managing UMT Roles"
Section 6.3, "Managing IRT Roles"

6.1 Managing InForm Roles

This section describes the following:

Section 6.1.1, "Viewing the List of InForm Roles"
Section 6.1.2, "Creating InForm Roles"
Section 6.1.3, "Viewing and Modifying InForm Role Details"
Section 6.1.4, "Viewing and Modifying InForm User-Role Associations"
Section 6.1.5, "Setting the Display Override Option"
Section 6.1.6, "Approving or Rejecting InForm Roles"
Section 6.1.7, "Transferring InForm Roles"

6.1.1 Viewing the List of InForm Roles

The InForm Roles page lets you view the list of InForm roles and its details. It also lets you filter roles based on the filter criteria.

To view the list of InForm roles:

Select Roles from the menu bar. The InForm Roles page is displayed.
Select the sponsor company and trial from the Current Sponsor Company and Trial drop-down lists. The list of InForm roles for the selected sponsor company and trial is displayed.

Note:
The trial selected must be an InForm trial else the InForm users tab is not displayed.
To filter roles, enter the filter criteria and click Find. The list of InForm roles that satisfy the specified filter criteria is displayed.

To specify the filter criteria, use the full name or the first few letters of the name.

For more details on how to filter and view InForm roles, see Section A.8.
To clear the filter criteria, click Clear.

Note:

To navigate through the InForm roles list, click the First, Previous, Next, or Last links.

To view a particular page, select the page from the drop-down list.

To view all the InForm roles on a single page, select All from the drop-down list.

Click the column name link to sort the InForm roles in the ascending or descending order, based on the column name. On the first click, the InForm roles are sorted in the ascending order. To sort the InForm roles in descending order, click the column name link again.

6.1.2 Creating InForm Roles

The Create InForm Role page lets you create a role and assign rights under various categories such as User administration, CRF rights, Case Book rights, Query rights, Rule rights, and System Administration rights. You can assign the roles to each user, which defines the access level of the account to the system.

To create InForm roles:

Select Roles from the menu bar. The InForm Roles page is displayed.
Select the sponsor company and trial from the Current Sponsor Company and Trial drop-down lists. The list of InForm roles for the selected sponsor company and trial is displayed.
Click the Create InForm Role link. The Create InForm Role page is displayed.
Enter the InForm role details. You can select the role type as Site, Sponsor, or both.

For more details on how to create InForm roles, see Section A.9.
Click Submit to save the details.

Note:

To save the current InForm role details and create another InForm role, click Submit and Add Another.

To go back to the List of InForm Roles page, click Return.

6.1.3 Viewing and Modifying InForm Role Details

The InForm Role Details page lets you view the rights associated with a role and modify the details, if required. When role details are modified, the reason for change is captured and the changes are tracked and audited. You can view the changes made to a particular field by viewing its corresponding audit trails.

To view and modify InForm role details:

Select Roles from the menu. On the InForm Roles page that appears, select the sponsor company and trial from the Current Sponsor Company and Trial drop-down lists. The list of InForm roles for the selected sponsor company and trial is displayed.
Click the role name link within the grid. On the InForm Roles page that appears, the details for the selected InForm role are displayed.
Modify the InForm role details.

The Associate users icon beside the Roles field displays user-role association. The icon is displayed only when a user is associated to a role.

For more details on how to modify the InForm role details, see Section A.10.

Note:
If you modify the current sponsor company or the trial displayed in the Current Sponsor Company and Trial drop-down lists, the InForm Roles page is displayed.
Enter the reason for modifying the details of the InForm role in the Reason For Change text box and click Go.
To cancel the changes made to the trial details, click Cancel.
To view the list of audit trails for a particular field, click the corresponding icon.

6.1.4 Viewing and Modifying InForm User-Role Associations

The User-Role Association page lets you view the list of users associated with the selected role. You can also add or remove users for the selected role.

To view and modify InForm user-role association:

Select Roles from the menu bar. The InForm Roles page is displayed.
Select the sponsor company and trial from the Current Sponsor Company and Trial drop-down lists. The list of InForm roles for the selected sponsor company and trial is displayed.
Click the icon corresponding to a role. The User-Role Association page is displayed, which shows the list of users for the selected role.
Modify the user-role association.

For more details on how to view and modify user-role association, see Section A.11.
Click Submit to save the changes.
To go back to the List of InForm Roles page, click Return.

6.1.5 Setting the Display Override Option

The Change Display Overrides page lets you set the display override option for an item group.

To set a display override option:

Select Roles from the menu bar. The InForm Roles page is displayed.
Select the sponsor company and trial from the Current Sponsor Company and Trial drop-down lists. The list of InForm roles for the selected sponsor company and trial is displayed.
Click the icon corresponding to a role.

You can set the display override option for item group as read only, editable, or hidden. Based on the option assigned to the role, a user can view or modify the item group.

The Change Display Overrides page is displayed, which shows the list of available and selected Item groups.
Modify the details.

For more details on how to view and modify the Display Override option, see Section A.12.
Click Submit to save the changes.
To go back to the List of InForm Roles page, click Return.

6.1.6 Approving or Rejecting InForm Roles

The InForm Roles page lets you approve and reject InForm roles. You can either approve or reject InForm roles depending on your access rights.

You can approve or reject only those roles which are in the Pending status.

To approve or reject InForm roles:

Select Roles from the menu bar. The InForm Roles page is displayed.
Select the sponsor company and trial from the Current Sponsor Company and Trial drop-down lists. The list of InForm roles for the selected sponsor company and trial is displayed.
Select the check box corresponding to the role you want to approve or reject.
Select Approve or Reject from the Select drop-down list. If you select Reject, enter the reason for rejection in the Comments text box.

Note:
If you select Approve, the Electronic Signature Affidavit page is displayed. Enter your password and click Submit. To cancel approval, click Cancel.
The Approval Status for the selected InForm role changes based on the action performed.
Click Go.

6.1.7 Transferring InForm Roles

The InForm Roles page also lets you transfer InForm roles.

To transfer InForm roles:

Select Roles from the menu bar. The InForm Roles page is displayed.
Select the sponsor company and trial from the Current Sponsor Company and Trial drop-down lists. The list of InForm roles for the selected sponsor company and trial is displayed.
Click the icon corresponding to the role you want to transfer.
Select the user from the User(s) Available (Role Name) text box and transfer to the Transfer to text box using the navigational buttons.
Select the required role from the drop-down list and click Submit.
Click OK on the dialog box that appears.
Click Return to go back to the List of InForm roles page.

The change is reflected in the Member Count and on the Users page.

6.2 Managing UMT Roles

This section contains the following topics:

Section 6.2.1, "Viewing the List of UMT Roles"
Section 6.2.2, "Creating UMT Roles"
Section 6.2.3, "UMT Roles and Rights"
Section 6.2.4, "Viewing and Modifying UMT Role Details"
Section 6.2.5, "Viewing and Modifying UMT User - Role Association"
Section 6.2.6, "Deleting UMT Roles"

6.2.1 Viewing the List of UMT Roles

The UMT Roles page lets you view the list of UMT roles and role details. This page also lets you filter the UMT roles based on the filter criteria.

To view the list of UMT roles:

Select Roles from the menu bar. On the page that appears, click the UMT Roles link. The UMT Roles page is displayed.
Select the sponsor company from the Current Sponsor Company drop-down list. The list of UMT roles for the selected sponsor company is displayed.
To filter the role, enter the role name in the Role Name text box and click Find. The list of UMT roles that satisfy the filter criteria is displayed.

To specify the filter criteria, use the full name or the first few letters of the name.

For more details on how to filter and view roles, see Section A.20.
To clear the filter criteria, click Clear.

Note:

To navigate through the UMT roles list, click the First, Previous, Next, or Last links.

To view a particular page, select the page from the drop-down list.

To view all the UMT roles on a single page, select All from the drop-down list.

Click the column name link to sort the UMT roles in the ascending or descending order, based on the column name. On the first click, the UMT roles are sorted in the ascending order. To sort the UMT roles in descending order, click the column name link again.

6.2.2 Creating UMT Roles

The Create UMT Role page lets you create a role and assign rights under various categories such as UMT Admin, Import, Export, User, Sponsor, Site Details, Log Files, Approval, InForm Rights, and Miscellaneous. You can assign all or some of the rights under each category to a user.

To create UMT roles:

Select Roles from the menu bar. On the page that appears, click the UMT Roles link.
On the UMT Roles page that appears, select the sponsor company from the Current Sponsor Company drop-down list. The list of UMT roles for the selected sponsor company is displayed.
Click the Create UMT Role link. The Create UMT Role page is displayed.
Enter the UMT role details.

For more details on how to create UMT roles, see Section A.35.
Click Submit to save the details.
To save the current UMT role details and create another UMT role, click Submit and Add Another.
To discard the changes, click Return.

6.2.3 UMT Roles and Rights

UMT roles are assigned certain rights and privileges that help them perform different tasks. Table 6-1 provides a list of various rights and privileges that are typically assigned to a UMT role.

Table 6-1 UMT Roles and Rights

Rights	Description
UMT Admin
Create UMT User	Create a UMT user.
Modify UMT User	Edit UMT user details.
View UMT User	View UMT user details.
Manage UMT User	Edit UMT user country details and user association with trials.
Create UMT Role	Create a UMT role.
Modify UMT Role	Sponsor Role Users: Modify sponsor role user details. PF Role Users: Update default role settings of PF role.
View UMT Role	View UMT user role details.
Manage UMT Role	Edit the association between a user and a role.
Modify UMT Configurations (PF Only)	Configure and edit UMT settings.
Modify Provisioned by (PF only),	Configure and edit provisioning Settings.
Manage IOL Training	Configure and edit IOL settings.
Import/Export
Import/Export	Import and export trial details.
Import Form and Items Ref Names	Import XML forms and item ref names.
Manage Auto Import Duplicates	Resolve automatically duplicated trial items.
User/Sponsor/Site Details
Create Sponsor	Create a sponsor.
Modify Sponsor Details	Edit sponsor details.
View Sponsor Details	View sponsor details.
Create Trial	Create a trial.
Modify Trial Details	Edit trial details.
Create InForm User	Create InForm user.
Modify InForm User	Edit InForm user details.
View InForm User	View InForm user details.
Manage InForm User	Associate a group and a role.
Create Site	Create a site.
Modify Site	Edit site details.
View Site Details	View site details.
Manage Site Details	Create and modify user and site association.
Load to InForm	Load user and site details to InForm.
Request InStruct account (IOL) (PF Only)	Request IOL training for PF users.
Copy Between Trials	Copy trial.
Manage Mass Associations	Enable mass association.
Lock Trial	Rights to lock trials.
View/Edit Pivotal Fields	Rights to view or edit Pivotal details.
Create/Edit UAT details	Rights to create or edit UAT details.
View Terminated User Details	Rights to view the terminated User Details.
View IRT User Details	Rights to view the IRT user details.
View IRT Site Details	Rights to view the IRT site details.
View IRT Right and Roles	Rights to view the IRT right and roles.
Manage IRT User Details	Rights to edit the IRT user details.
Manage IRT Site Details	Rights to edit the IRT site details.
Manage IRT Right and Roles	Rights to edit the IRT right and roles.
Load to IRT	Load user and site details to IRT.
Create OLx User	To create an OLx user.
View OLx User	To view OLx user.
Modify OLx user	Modify existing OLx user.
Manage OLx user	To manage OLx users.
Load to OLx	Load user and site details to OLx.
Log Files
View Import/Export Log File	View MUL application log files.
View Data Transfer Log to Pivotal (PF Only)	View Pivotal application log files.
View Data Transfer Log to InForm (PF Only)	View InForm application log files.
View Data Transfer Log to eCS (PF Only)	View eCS application log files.
View Data Transfer Log to IOL* (PF Only)	View IOL application log files.
View Training Log (PF Only)	Enable the training logs menu.
Approval
Approve Site Details	Approve or reject site details.
Approve InForm User Details	Approve, reject or terminate InForm user.
Approve InForm Rights and Role	Approve or reject InForm role.
Approve InForm Groups	Approve or reject InForm group.
Approve InForm Configuration	Approve or reject InForm settings.
Approve IRT Rights and Role	Approve or reject IRT role.
InForm Rights
Edit InForm Config Settings	Edit the InForm configuration settings.
Create InForm Rights and Role	Create InForm rights and roles.
Modify InForm Rights and Role	Edit InForm rights and roles.
Manage InForm Rights and Role	Manage the user-role associations.
Create InForm Groups	Create InForm group details.
Modify InForm Groups	Edit InForm group details.
Manage InForm Groups	To enable user, role association with groups. Associate an InForm group with a user and a group.
View InForm Config	View InForm configuration details.
View InForm Rights and Roles	View InForm rights and roles.
View InForm Groups	View InForm groups.
Create OLx Rights and Role	To create OLx rights and role.
Modify OLx Rights and Role	To modify OLx rights and role.
Manage OLx Rights and Role	To manage OLx roles and rights.
View OLx Roles and Rights	To view OLx roles and rights.
Miscellaneous
View Reports	To view billing details report, training report, and assessment detail report.

6.2.4 Viewing and Modifying UMT Role Details

The UMT Role Details page lets you view the rights associated with a role and modify the details, if required. If the role details are modified, the reason for change is captured and the changes are tracked and audited. You can view the changes made to a particular field by viewing its corresponding audit trail.

To view and modify UMT role details:

Select Roles from the menu bar. On the page that appears, click the UMT Roles link. The UMT Roles page is displayed.
Select the sponsor company from the Current Sponsor Company drop-down list. The list of UMT roles for the selected sponsor company is displayed.
Click the role name link in the grid. The UMT Role Details page is displayed, which shows the selected UMT role details.
Modify the UMT role details.

For more details on how to modify the UMT role details, Section A.33.

Note:
If the sponsor company in the Current Sponsor Company drop-down list is changed to another sponsor company, the UMT Roles page is displayed.
Enter the reason for modifying the details of the UMT role in the Reason For Change text box and click Submit.
To cancel the changes made to the UMT role details, click Cancel.
To view the list of audit trails for a particular field, click the corresponding icon.

6.2.5 Viewing and Modifying UMT User - Role Association

The User - Role Association page lets you view the list of users associated with the selected role. You can also add or remove users for the selected role.

To view and modify UMT user-role association:

Select Roles from the menu bar. On the page that appears, click the UMT Roles link. The UMT Roles page is displayed.
Select the sponsor company from the Current Sponsor Company drop-down list. The list of UMT roles for the selected sponsor company is displayed.
Click the icon corresponding to a role. The User-Role Association page is displayed, which shows the list of users for the selected role.
Modify the user-role association.

For more details on how to view and modify the user-role associations, see Section A.11.
Click Submit to save the changes.
To cancel the changes, click Return.

6.2.6 Deleting UMT Roles

The UMT Roles page lets you delete roles. However, you must specify the reason for deleting the UMT role.

To delete UMT roles:

Select Roles from the menu bar. On the page that appears, click the UMT Roles link. The UMT Roles page is displayed.
Select the sponsor company from the Current Sponsor Company drop-down list. The list of UMT roles for the selected sponsor company is displayed.
Select the check box corresponding to the role you want to delete.
Enter the reason for deleting the role in the Comments text box and click Delete.

6.3 Managing IRT Roles

This section contains the following topics:

Section 6.3.1, "Viewing the List of IRT Roles"
Section 6.3.2, "Creating IRT Roles"
Section 6.3.3, "Approving or Rejecting IRT Roles"

6.3.1 Viewing the List of IRT Roles

The IRT Roles page lets you view the list of IRT roles and role details. This page also lets you filter the IRT roles based on the filter criteria.

To view the list of IRT roles:

Select Roles from the menu bar. On the page that appears, click the IRT Roles link. The IRT Roles page is displayed.
Select the sponsor company and trial from the Current Sponsor Company and Trial drop-down lists. The list of IRT roles for the selected sponsor company is displayed.
To filter the role, enter the role name in the Role Name text box and click Find. The list of IRT roles that satisfy the filter criteria is displayed.

To specify the filter criteria, use the full name or the first few letters of the name.
To clear the filter criteria, click Clear.

Note:

To navigate through the IRT roles list, click the First, Previous, Next, or Last links.

To view a particular page, select the page from the drop-down list.

To view all the IRT roles on a single page, select All from the drop-down list.

Click the column name link to sort the IRT roles in the ascending or descending order, based on the column name. On the first click, the IRT roles are sorted in the ascending order. To sort the IRT roles in descending order, click the column name link again.

6.3.2 Creating IRT Roles

The Create IRT Role page lets you create a role and assign rights under various categories such as Subject Related, Study Admin Activities, Site Admin Activities, User Related Activities, Drug Related Activities, Reports, Ad-Hoc Reports, and Instructions and Forms. You can assign all or some of the rights under each category to a user.

To create IRT roles:

Select Roles from the menu bar. On the page that appears, click the IRT Roles link. The IRT Roles page is displayed.
Select the sponsor company and trial from the Current Sponsor Company and Trial drop-down lists. The list of IRT roles for the selected sponsor company is displayed.
Click the Create IRT Role link. The Create IRT Role page is displayed.
Enter the IRT role details.
Click Submit to save the details.
To save the current IRT role details and create another IRT role, click Submit and Add Another.
To discard the changes, click Return.

6.3.3 Approving or Rejecting IRT Roles

The IRT Roles page lets you view approve or reject IRT roles.

To approve or reject IRT roles:

Select Roles from the menu bar. On the page that appears, click the IRT Roles link. The IRT Roles page is displayed.
Select the sponsor company and trial from the Current Sponsor Company and Trial drop-down lists. The list of IRT roles for the selected sponsor company is displayed.
Select the check box corresponding to the role you want to approve or reject.
Enter the reasons in the Comments text box and click Go.