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Oracle® User Management Tool User's Guide
Release 12.0.1

E57087-01
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3 Managing Users

This chapter contains the following topics:

3.1 User Types

The following are the types of users:

The InForm, Oracle, and Global users can be enabled for single sign-on (SSO), which is a user authentication process. It lets users use single user name and password to access multiple trials and applications within a sponsor or a clinical research organization (CRO). It also lets users to switch from one application or trial to another without re-signing.

3.2 InForm, IRT, and OLx Users

This section contains the following topics:

3.2.1 Viewing the List of InForm, IRT, or OLx Users

The InForm Users page lets you manage InForm, IRT, and OLx users. You can view the list of InForm users and their details on this page. Additionally, it lets you filter the users based on the filter criteria.

To view the list of InForm users:

  1. Select Users from the menu bar. The InForm Users page is displayed.

  2. Select the sponsor company and trial from the Current Sponsor Company and Trial drop-down lists. The list of InForm users for the selected sponsor company and trial is displayed.

  3. To filter users, enter the filter criteria, and click Find. The list of InForm users that satisfy the specified filter criteria is displayed.

    For more details on how to filter and view InForm, IRT, and OLx users, see Section A.1.

  4. To clear the filter criteria, click Clear.

    While specifying the filter criteria, you can use the full name or part of the name.

Note:

To navigate through the user 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 users on a single page, select All from the drop-down list.

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

3.2.2 Creating InForm, IRT, or OLx Users

The Create InForm Details page lets you create three types of InForm users, that is, PF users, sponsor users, and site users. Only PF users (Administrators) can create both PF and sponsor users, and associate with any sponsor. Sponsor users can create only sponsor users within that sponsor. Enter the user details and user association to create a new InForm user.

To create InForm users:

  1. Select Users from the menu bar. The InForm Users page is displayed.

  2. Select the sponsor company and trial from the Current Sponsor Company and Trial drop-down lists. The list of InForm users for the selected sponsor company and trial is displayed.

  3. Click the Create InForm User link. The Create InForm User Details page is displayed.

  4. Enter the user details and user association.

    For more details on how to create InForm, IRT, and OLX users, see Section A.1.

    Note:

    The User Association section, on the Create InForm User Details page, varies depending upon the selected User Type.
  5. Click Submit to save the user details.

Note:

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

To discard the changes, click Return.

3.2.3 Viewing and Modifying InForm User Details

The InForm User Details page lets you view and modify InForm user details. If the user 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 user details:

  1. Select Users from the menu bar. On the InForm Users page that appears, select the sponsor company and trial from the Current Sponsor Company and Trial drop-down lists. The list of InForm users for the selected sponsor company and trial is displayed.

  2. Click the Username link. On the InForm User Details page that appears, the user details for the selected user are displayed.

  3. Modify the user details.

    For more details on how to modify InForm, IRT, and OLX user details, see Section A.3.

    Note:

    If you modify the current sponsor company or the trial displayed in the Current Sponsor Company and Trial drop-down lists, the InForm Users page is displayed.
  4. Enter the reason for modifying the user details in the Reason for Change text box and click Submit.

Note:

To cancel the changes made to the InForm user details, click Return.

To view the list of audit trails for a particular field, click the corresponding icon.

3.2.4 Viewing Multiple Association

The Multiple Association icon lets you view the sites associated with the user. You can also request equipment assessment for the site or mark the site as assessed or request immediate provisioning.

To view multiple associations:

  1. Select Users from the menu bar. The InForm Users page is displayed.

  2. Select the sponsor company and trial from the Current Sponsor Company and Trial drop-down lists. The list of InForm users for the selected sponsor company and trial is displayed.

  3. Click the users associated sites icon icon in the Site(s) column. On the page that appears, the list of users and their associated sites are displayed.

    Note:

    The users associated sites icon icon is active only for non-ZPF users.
  4. Select a user from the Select Username list box and click Go. The list of sites to which the user is associated is displayed.

    For more details on multiple associations, see Section A.4.

Note:

To navigate through the user 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 users on a single page, select All from the drop-down list.

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

To view the list of InForm users, click Return.

3.2.5 Associating a User with a Site

You can associate a user with all sites located within a country and time zone. Only sponsor users can be associated with sites within a country and/or a time zone.

To automatically associate a user to a site:

  1. Select Users from the menu bar. The InForm Users page is displayed.

  2. Select the sponsor company and trial from the Current Sponsor Company and Trial drop-down lists. The list of InForm users for the selected sponsor company and trial is displayed.

  3. Click the required sponsor user name link in the grid. The Edit InForm User Details page displays the details of the sponsor user.

  4. Select Country or Country & TimeZone from the Filter By drop-down list.

  5. Select the required country or country and time zone from the drop-down list.

  6. Select the Automatic Association check box.

  7. Enter the reason for modifying the user details in the Reason for change text box and click Submit.

    The sponsor user is automatically associated with all the sites of the selected country and time zone.

3.2.6 Terminating InForm Users

The InForm Users page lets you terminate InForm users. You can also view the list of terminated users.

To terminate InForm users:

  1. Select Users from the menu bar. The InForm Users page appears.

  2. Select the sponsor company and trial from the Current Sponsor Company and Trial drop-down lists. The list of InForm users for the selected sponsor company and trial is displayed.

  3. Select the check box corresponding to the user you want to terminate.

  4. Select Terminate User from the Select drop-down list.

  5. Enter the details in the Comments check box and click Go.

  6. On the confirmation dialog box that appears, click OK to terminate the selected InForm user.

    Note:

    To cancel termination of the InForm user, click Cancel.
  7. Click OK on the dialog box that appears on successful termination of the InForm user.

3.2.7 Viewing Terminated InForm Users

The InForm Terminated User List page displays the list of terminated InForm users. You can view the user name, first name, last name, and country of the terminated users.

To view terminated InForm users:

  1. Select Users from the menu bar. The InForm Users page is displayed.

  2. Select the sponsor company and trial from the Current Sponsor Company and Trial drop-down lists. The list of InForm users for the selected sponsor company and trial is displayed.

  3. Click the Terminated User List link. The InForm Terminated User List page is displayed, which shows the list of terminated users.

    For more details on InForm terminated user list, see Section A.65.

    Note:

    To go back to the previous page, click Return.

3.2.8 Unterminating InForm Users

The Terminated User List page lets you revoke the termination of InForm users. You can either revoke the termination of all users or a particular user.

To unterminate InForm users:

  1. Select Users from the menu bar. The InForm Users page is displayed.

  2. Select the sponsor company and trial from the Current Sponsor Company and Trial drop-down lists. The list of InForm users for the selected sponsor company and trial is displayed.

  3. Click the Terminated User List link. The InForm Terminated User List page is displayed.

  4. Select the check box corresponding to the user whose termination you want to revoke and click Unterminate.

  5. Click OK in the dialog box that appears on revoking the termination of the InForm user.

    Note:

    To go back to the previous page, click Back.

3.2.9 Approving or Rejecting InForm Users

The Approve and Reject options available on the InForm Users page let you approve and reject InForm users. You can approve or reject a user, only if the user status is pending. If user details or association are changed, the approved or rejected status is changed to Pending or Approved based on the approval rights of the user logged in.

To approve or reject InForm users:

  1. Select Users from the menu bar. The InForm Users page is displayed.

  2. Select the sponsor company and trial from the Current Sponsor Company and Trial drop-down lists. The list of InForm users for the selected sponsor company and trial is displayed.

  3. Select the check box corresponding to the user you want to approve or reject.

  4. Select Approve or Reject from the Select drop-down list.

    • If you select Reject, enter the reason for rejecting the user in the Comments text box.

    • 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 user changes based on the action performed.

  5. Click Go.

3.2.10 Marking Users for Upload to InForm

The InForm user details created in UMT can be uploaded into the InForm system. The Load to InForm option on the InForm Users page lets you mark users for upload.

To mark users for upload to InForm:

  1. Select Users from the menu bar. The InForm Users page is displayed.

  2. Select the sponsor company and trial from the Current Sponsor Company and Trial drop-down lists. The list of InForm users for the selected sponsor company and trial is displayed.

  3. Select the check box corresponding to the user you want to upload to InForm.

  4. Select Mark Upload To InForm from the Select drop-down list.

  5. Enter the reasons in the Comments text box and click Go.

3.2.11 Marking Users as Trained

The InForm user created may already be trained or may require training. The InForm Users page lets you mark a user as trained. You can also enter this information while creating or modifying the InForm user details.

To mark a user as trained:

  1. Select Users from the menu bar. The InForm Users page is displayed.

  2. Select the sponsor company and trial from the Current Sponsor Company and Trial drop-down lists. The list of InForm users for the selected sponsor company and trial is displayed.

  3. Select the check box corresponding to the user you want to mark as trained.

  4. Select Mark as Trained from the Select drop-down list.

    Note:

    You can mark a user as trained only if the user is approved.
  5. Enter the reason for marking the user as trained in the Comments text box and click Go.

    The selected user is marked as trained.

3.2.12 Assigning IOL Classes

This feature is only usable for trials for which the Switchoff IOL option (on the Configuration Settings page) is not selected, that is, the UMT-IOL integration is enabled for the trials. For more details on configuration settings, see Chapter 14.

To assign an IOL class to a user:

  1. Select Users from the menu bar. The InForm Users page is displayed.

  2. Select the sponsor company and trial from the Current Sponsor Company and Trial drop-down lists. The list of InForm users for the selected sponsor company and trial is displayed.

  3. Select the check box corresponding to the user you want to assign the IOL class to.

  4. Select Assign IOL Class from the Select drop-down list.

  5. Enter the reason in the Comments text box and click Go. The Request Training page is displayed.

  6. Move the appropriate IOL class into the Selected window and click Submit.

3.2.13 Sending InForm Account Details

The Send InForm Account Details option lets you send the InForm account details to the selected users in the form of an email. This email contains the study URL of a particular trial. Additionally, emails containing the InForm user name and password are sent by the UMT system. However, these actions take place only if the Upload to InForm status is complete and the trial is in a golive state.

To send InForm account details:

  1. Select Users from the menu bar. The InForm Users page is displayed.

  2. Select the sponsor company and trial from the Current Sponsor Company and Trial drop-down lists. The list of InForm users for the selected sponsor company and trial is displayed.

  3. Select the check box corresponding to the user you want to send the InForm account details.

  4. Select Send InForm Account Details from the Select drop-down list and click Go.

  5. Click Go on the confirmation dialog box.

3.2.14 Exporting InForm Users

The Export to Excel and Export to File links available on the InForm Users page let you export InForm users. You can export the InForm user details either to an Excel spreadsheet or to a flat file.

To export InForm users:

  1. Select Users from the menu bar. The InForm Users page is displayed.

  2. Select the sponsor company and trial from the Current Sponsor Company and Trial drop-down lists. The list of InForm users for the selected sponsor company and trial is displayed.

  3. Select the check box corresponding to the user you want to export.

  4. Click the Export to Excel or Export to File link. On the dialog box that appears, click Open to open the file or click Save to save the file.

3.2.15 Marking Users for Upload to IRT

The Load to IRT option on the InForm Users page lets you mark users for upload to IRT.

To mark users for upload to IRT:

  1. Select Users from the menu bar. The InForm Users page is displayed.

  2. Select the sponsor company and trial from the Current Sponsor Company and Trial drop-down lists. The list of InForm users for the selected sponsor company and trial is displayed.

  3. Select the check box corresponding to the user you want to upload to IRT.

  4. Select Mark Upload To IRT from the Select drop-down list.

  5. Enter the reasons in the Comments text box and click Go.

3.2.16 Marking Users for Load to OLx

The Load to OLx option on the InForm Users page lets you mark users for upload to OLx.

To mark users for upload to OLx:

  1. Select Users from the menu bar. The InForm Users page is displayed.

  2. Select the sponsor company and trial from the Current Sponsor Company and Trial drop-down lists. The list of InForm users for the selected sponsor company and trial is displayed.

  3. Select the check box corresponding to the user you want to upload to OLx.

  4. Select Mark Upload To OLx from the Select drop-down list.

  5. Enter the reasons in the Comments text box and click Go.

3.2.17 Marking Users for Updating User Name in Email Notifications

The Update User Name in Email Notifications option on the InForm Users page lets you mark users for updating user name in email notifications.

To mark users for updating user name in email notifications:

  1. Select Users from the menu bar. The InForm Users page is displayed.

  2. Select the sponsor company and trial from the Current Sponsor Company and Trial drop-down lists. The list of InForm users for the selected sponsor company and trial is displayed.

  3. Select the check box corresponding to the user you want to mark for updating the user name in email notifications.

  4. Select Update User Name in Email Notifications from the Select drop-down list.

  5. Select the corresponding option from the User Name Order drop-down list.

  6. Click Go.

3.2.18 Updating Assessment Status

The Update Assessment Status option on the InForm Users page lets you update the assessment status of the InForm users.

To update the assessment status of InForm users:

  1. Select Users from the menu bar. The InForm Users page is displayed.

  2. Select the sponsor company and trial from the Current Sponsor Company and Trial drop-down lists. The list of InForm users for the selected sponsor company and trial is displayed.

  3. Select the check box corresponding to the user whose assessment status you want to update.

  4. Select Update Assessment Status from the Select drop-down list.

  5. Enter the reasons in the Comments text box and click Go.

    The Update Assessment Status page is displayed.

  6. Select the check box corresponding to the status you want to update.

  7. Enter the reasons in the Assessment Summary Box and click Update.

Note:

Click Return to go back to the InForm Users page.

3.2.19 Assigning Preferred Study Locale

The Edit Oracle User Details page lets you assign a preferred study locale to InForm users.

To assign a preferred study locale to an InForm user:

  1. Select Users from the menu bar. The InForm Users page is displayed.

  2. Select the sponsor company and trial from the Current Sponsor Company and Trial drop-down lists. The list of InForm users for the selected sponsor company and trial is displayed.

  3. Select the check box corresponding to the user whose preferred study locale you want to update.

  4. Select Assign Preferred Study Locale from the Select drop-down list.

  5. Select the preferred language from the Language drop-down list.

  6. Enter the reason in the Comments text box and click Go.

Note:

To cancel the changes made to the user details, click Return.

3.3 UMT Users

This section contains the following topics:

3.3.1 Viewing the List of UMT Users

The UMT Users page lets you view the list of UMT users and their details. It also lets you filter the UMT users based on the filter criteria.

To view the list of UMT users:

  1. Select Users from the menu bar. On the page that appears, click the UMT Users link.

  2. On the UMT Users page, select the sponsor company from the Current Sponsor Company drop-down list. The list of UMT users for the selected sponsor company is displayed.

  3. To filter UMT users, enter the filter criteria and click Find. The list of UMT users that satisfy the specified filter criteria is displayed.

    While specifying the filter criteria, you can either use the full name or the first few letters of the name.

    For more details on how to filter and view UMT users, see Section A.34.

  4. To clear the filter criteria, click Clear.

    Note:

    To navigate through the user 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 users on a single page, select All from the drop-down list.

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

3.3.2 Creating UMT Users

The Create UMT User Details page lets you create following UMT users:

  • PF users - Only PF users (Administrators) can create both PF and sponsor users and associate UMT users with any sponsor. PF users have access to all sponsors.

  • Sponsor users - A sponsor user can create only sponsor users within that sponsor. Sponsor users can access only their own data and cannot view other sponsor details.

To create UMT users:

  1. Select Users from the menu bar. On the page that appears, click the UMT Users link.

  2. On the UMT Users page, select the sponsor company from the Current Sponsor Company drop-down list. The list of UMT users for the selected sponsor company is displayed.

    Note:

    To create a user for all sponsors, select All from the drop-down list.
  3. Click the Create UMT User link. The Create UMT User Details page is displayed.

  4. Enter the user details and assign a role for the user.

    For more details on how to create UMT users, see Section A.34.

    Note:

    To override, click OK in the dialog box that appears. Click Cancel to change the email address.
  5. Click Submit to save the user details.

  6. To save the current user details and create another UMT user, click Submit and Add Another.

  7. To discard the changes, click Return.

    On successful creation of the UMT user, the user name and temporary password are sent to the email address specified on the Create UMT User Details page.

3.3.3 Viewing and Modifying UMT User Details

The UMT User Details page lets you view and modify UMT user details. If the user 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 UMT user details:

  1. Select Users from the menu bar. On the page that appears, click the UMT Users link.

  2. On the UMT Users page, select the sponsor company from the Current Sponsor Company drop-down list. The list of UMT users for the selected sponsor company is displayed.

  3. Click the user name link. The UMT User Details page is displayed, which shows the details for the selected user.

  4. Modify the user details.

    For more details on how to modify UMT user details, see Section A.34.

    Note:

    If the sponsor company in the Current Sponsor Company drop-down list is changed to another sponsor company, the UMT Users page is displayed.
  5. Enter the reason for modifying the user details in the Reason for Change text box and click Submit.

  6. To cancel the changes made to the UMT user details, click Return.

  7. To view the list of audit trails for a particular field, click the corresponding icon.

3.3.4 Activating UMT Users

The UMT Users page also lets you activate UMT users.

To activate UMT users:

  1. Select Users from the menu bar. On the page that appears, click the UMT Users link.

  2. On the UMT Users page, select the sponsor company from the Current Sponsor Company drop-down list. The list of UMT users for the selected sponsor company is displayed.

  3. Select the check box corresponding to the user you want to activate or inactivate.

  4. Select Activate from the Select drop-down list and enter the reason for activating the user in the Comments text box. Click Go.

  5. Click OK on the dialog box that appears on successful activation of the UMT user.

    Note:

    The status for the selected user changes based on the action performed.

3.3.5 Terminating UMT Users

The UMT Users page lets you terminate UMT users. You can also view the list of terminated users.

To terminate UMT users:

  1. Select Users from the menu bar. On the page that appears, click the UMT Users link.

  2. On the UMT Users page, select the sponsor company from the Current Sponsor Company drop-down list. The list of UMT users for the selected sponsor company is displayed.

  3. Select the check box corresponding to the user you want to terminate.

  4. Select Terminate from the Select drop-down list.

  5. Enter the reason for terminating the user in the Comments text box and click Go.

  6. On the confirmation dialog box that appears, click OK to terminate the selected UMT user.

    Note:

    To cancel termination of the UMT user, click Cancel.
  7. Click OK on the dialog box that appears on successful termination of the UMT user.

3.3.6 Viewing Terminated UMT Users

The Terminated User List page displays the list of terminated UMT users. You can view the user name, first name, last name, and country of the terminated users.

To view terminated UMT users:

  1. Select Users from the menu bar. On the page that appears, click the UMT Users link.

  2. On the UMT Users page, select the sponsor company from the Current Sponsor Company drop-down list. The list of UMT users for the selected sponsor company is displayed.

  3. Click the Terminated User List link. The list of terminated users is displayed.

    Note:

    To go back to the previous page, click Return.

3.3.7 Unterminating UMT Users

The Terminated User List page lets you revoke the termination of UMT users. You can either revoke the termination of all users or a particular user.

To unterminate UMT users:

  1. Select Users from the menu bar. On the page that appears, click the UMT Users link.

  2. On the UMT Users page, select the sponsor company from the Current Sponsor Company drop-down list. The list of UMT users for the selected sponsor company is displayed.

  3. Click the Terminated User List link. The Terminated User List page is displayed.

  4. Select the check box corresponding to the user you want to revoke the termination and click Unterminate.

  5. Click OK on the dialog box that appears on revoking the termination of the UMT user.

    Note:

    To go back to the previous page, click Return.

3.3.8 Resetting the Password for UMT Users

The login password for an UMT user can be reset in case the password is blocked or expired.

To reset password for UMT users:

  1. Select Users from the menu bar. On the page that appears, click the UMT Users link.

  2. On the UMT Users page, select the sponsor company from the Current Sponsor Company drop-down list. The list of UMT users for the selected sponsor company is displayed.

  3. Select the check box corresponding to the user you want to reset the password.

  4. Select Reset Password from the Select drop-down list.

  5. Enter the reason for resetting the password in the Comments text box.

  6. Click Go. Click OK on the dialog box that appears.

3.3.9 Resending UMT Login Details

The UMT Users page also lets you resend UMT login details to a user.

To resend login details of UMT users:

  1. Select Users from the menu bar. On the page that appears, click the UMT Users link.

  2. On the UMT Users page, select the sponsor company from the Current Sponsor Company drop-down list. The list of UMT users for the selected sponsor company is displayed.

  3. Select the check box corresponding to the user whose login details you want to resend.

  4. Select Resend UMT Login Details from the Select drop-down list.

  5. Enter the reason for resending the details in the Comments text box.

  6. Click Go.

  7. Click OK on the dialog box that appears.

3.4 Oracle Users

This section contains the following topics:

3.4.1 Viewing the List of Oracle Users

The Oracle Users page lets you view the list of Oracle users and their details. This page also lets you filter Oracle users based on the filter criteria.

To view the list of Oracle users:

  1. Select Users from the menu bar. On the page that appears, click the Oracle Users link.

  2. Set the Current Sponsor Company and Trial drop-down lists to Select by default.

    The list of Oracle users is displayed on the Oracle Users page.

  3. To filter users, enter the filter criteria and click Find. The list of Oracle users that satisfy the specified filter criteria is displayed. For more details on how to filter and view Oracle users, see Section A.64.

    Note:

    While specifying the filter criteria, you can either use the full name or part of the name.
  4. To clear the filter criteria, click Clear.

    Note:

    To navigate through the user 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 users on a single page, select All from the drop-down list.

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

Oracle users having Modify Oracle Rights can approve or reject users on the Oracle Users list page.

Select Mark upload to InForm from the action item drop-down list. The Sponsor and Trial drop-down lists are displayed.

  • Set sponsor and trial to All for the user to be associated with all sponsors and trials.

  • Set trial to All for the user to be associated with all trials of the selected sponsor.

  • Select a sponsor and trial for the user to be associated with only that trial and sponsor.

Use the + icon for associating a site with each user record. The site association popup is displayed on the basis of the site selected.

You can download the Excel template.

3.4.2 Creating Oracle Users

The Create Oracle User page lets you create an Oracle user. To create an Oracle user, you must have the Create Oracle User rights. You can create only Oracle user type users.

To create Oracle users:

  1. Select Users from the menu bar. On the page that appears, click the Oracle Users link.

  2. Set the Current Sponsor Company and Trial drop-down lists to Select by default.

    The list of Oracle users is displayed on the Oracle Users page.

  3. Click the Create Oracle User link. The Create Oracle User Details page is displayed.

  4. Enter the Oracle user's details.

    For more details on how to create Oracle users, see Section A.40.

  5. On the Create Oracle User Details page, associate the user with a sponsor and trial.

    • To associate a user with all sponsors and trials, select All from the Select Sponsor and Select Trial drop-down lists.

    • To associate a user with one sponsor and all trials, select the sponsor from the Select Sponsor drop-down list, and select All from the Select Trial drop-down list.

    • To associate a user with all sponsors and one trial, select All from the Select Sponsor drop-down list, and select a trial from the Select Trial drop-down list.

    Note:

    To save the current Oracle user details and create another Oracle user, click Submit and Add Another.

    To discard the changes, click Return.

3.4.3 Viewing and Modifying Oracle User Details

The PF User Edit page lets you view and modify the PF user details. If the user 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 PF user details:

  1. Select Users from the menu. On that page, click the Oracle Users link. The list of Oracle Users is displayed.

    Note:

    The Sponsor and Trial drop-down lists should be set by default to Select.
  2. Click the required username link in the grid. The Edit Oracle User Details page appears that displays the user details for the selected user.

  3. Modify the user details as required.

    For more details on how to create Oracle users, see Section A.40.

  4. Enter the reason for modifying the user details in the Reason for change text box and click Submit.

  5. On the Edit Oracle User Details page, associate the user to sponsor and trial.

    • If sponsor and trial are set to All, the user is associated with all sponsors and trials.

    • If trial is set to All and one sponsor is selected, the user is associated with all trials of the selected sponsor.

    • If one sponsor and trial are selected, the user is associated only with that selected trial and sponsor.

      Note:

      To cancel the changes made to the user details, click Return.

      To view the list of audit trails for a particular field, click the corresponding icon.

3.5 Global Users

A Global user is a user managed by Oracle Identity Management suite. You can assign Global user to multiple InForm trials and applications within a sponsor or a CRO. A Global user that has access to applications for multiple sponsors or CROs will have a unique identity per sponsor or CRO. You can update the Global users' details, assign them to trials, or globally de-provision.

This section contains the following topics:

Note:

Global Users feature is enabled only if Switchoff Global User option (on the Configuration Settings page) is not selected.

3.5.1 Viewing the List of Global Users

The Global Users page lets you view the list of Global users and their details. It lets you filter the Global users based on the filter criteria. You can also associate the product to the user here.

To view the list of Global users:

  1. Select Users from the menu bar. On the page that appears, click the Global Users link.

  2. On the Global Users page, select the sponsor company from the Current Sponsor Company drop-down list. The list of Global users for the selected sponsor company is displayed.

  3. To filter users, enter the filter criteria and click Find. The list of Global users that satisfy the specified filter criteria is displayed.

    For more details on how to filter and view Global Users, see Section A.5.

Note:

To clear the filter criteria, click Clear.

While specifying the filter criteria, you can either use the full name or the first few letters of the name.

To navigate through the user 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 users on a single page, select All from the drop-down list.

Click the column name link to sort the Global users either in the ascending or descending order, based on the column name. On the first click, the users are sorted in the ascending order. If you want to sort the users in descending order, click the column name link again.

A new link Import on Global User List page is displayed. On clicking this menu, a new page Import is available.

You can download the Excel template and use it to perform bulk import of Global Users.

3.5.2 Creating Global Users

The Create Global User page lets you create a global user. To create a global user, you must have the Manage Global User rights. You can create two types of global users, that is site users and sponsor users.

To create Global users:

  1. Select Users from the menu bar.

  2. On the Global Users page, select the sponsor company from the Current Sponsor Company drop-down list.

  3. Click the Global Users link. The list of users for the selected sponsor company is displayed.

  4. Click the Create Global User link. The Create Global User page is displayed.

  5. Enter the global user details.

    For more details on how to create Global Users, see Section A.6.

  6. To save the current Global User details and create another, click Submit and Add Another.

Note:

To create a Global User, the values entered in the UserName, First Name, Last Name, and E-mail ID fields must be unique.
  • If you try creating a Global user with duplicate values in the First Name, Last Name, User Name, or Email Address fields, an error message User already exists is displayed and the user is not created.

  • If you try creating a Global user with duplicate values in the First Name, Last Name, and Email ID fields, with a different User Name, an error message First Name, Last Name and Email ID combination already exists in the sponsor is displayed and the user is not created.

To discard the changes, click Return.

3.5.3 Assigning a Product

The Assign Product action item on Global Users page lets you assign global users to a product.

To assign global users to a product:

  1. Select Users from the menu bar. On the page that appears, click the Global User link.

  2. On the Global Users page, select the sponsor company from the Current Sponsor Company drop-down list. The list of Global Users for the selected sponsor company is displayed.

  3. Select the check boxes corresponding to the user you want to assign a product and click Assign Product.

  4. Select the product type from the Product drop-down list.

  5. Select the trial version from the Trial Version drop-down list that appears.

  6. Select the trial from the Trial drop-down list that appears.

    The trial gets populated based on the selected trial version and product. On selecting the trial, the user information associated with that trial is displayed.

    Note:

    You can add new users to the selected product and can also edit existing users.

    IRT roles are displayed on selecting only the IRT trial.

    InForm roles are displayed on selecting only InForm trial.

    Both IRT and InForm roles are displayed for joint IRT and InForm trials.

  7. Select the InForm Role, IRT Role, User name in Email Notification, Preferred study locale, Product Locale, Load To InForm, and Load To IRT details from their respective drop-down lists.

  8. To associate a site with a user:

    1. Click the + icon. The site association list based on the trial selected is displayed.

    2. Select the site you want to associate with a user and use the navigational keys to the Selected text box.

    3. Click Save and click OK on the confirmation dialog box.

  9. Enter the reasons in the Comments text box and click Submit.

  10. Click OK on the confirmation dialog box that appears.

  11. Click Return to go back to the Global Users page.

3.5.4 Viewing and Modifying Global User Details

The Global User page lets you view and modify Global user details. If the user 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 Global user details:

  1. Select Users from the menu bar. Select the sponsor company and click the Global Users tab. The list of Global users for that selected sponsor company is displayed.

  2. Click the Username link in the grid. The Global User Details page is displayed, which shows the user details for the selected user.

  3. Modify the user details.

    For more details on how to filter and view Global Users, see Section A.7.

    On changing the current sponsor company in the drop-down list, the users belonging to that sponsor are displayed.

  4. Enter the reason for modifying the user details in the Reason for Change text box and click Submit.

    When editing a Global user, ensure the User Name, First Name, Last Name, and E-mail ID are unique.

    Note:

    If a user is assigned to trials and the Global User record is modified, the changes are reflected across all trials the user is associated to.

    Note:

    If you try to edit a Global user record with already existing First Name, Last Name, Email ID and User Name, an error message User already exists is displayed on clicking Submit.

    If you try to edit a Global user record with an already existing First Name, Last Name, and Email ID, which already exists but with a different User Name, an error message First Name, Last Name and Email Id combination already exists in the sponsor is displayed on clicking Submit.

    If you try to edit a Global user record with a different First Name, Last Name, and Email ID, but with an existing User Name, an error message User Name already Exists is displayed on clicking Submit.

  5. To cancel the changes made to the user details, click Return.

  6. To view the list of audit trails for a particular field, click the corresponding icon.

3.5.5 Terminating a Global User

The Global Users page lets you terminate a global user.

Note:

Terminating a Global User will terminate the user across all products the user is assigned to.

To terminate a global user:

  1. Select Users from the menu bar. On the page that appears, click the Global User link.

  2. On the Global Users page, select the sponsor company from the Current Sponsor Company drop-down list. The list of Global Users for the selected sponsor company is displayed.

  3. Select the check boxes corresponding to the user you want to terminate and select Terminate User from the Select drop-down list.

  4. Enter the reasons in the Comments text box and click Submit.

  5. Click OK on the confirmation dialog box that appears.

3.5.6 Viewing the Terminated User List

The Terminated User List page displays the list of terminated global users. You can view the user name, first name, last name, country, and email address of the terminated users.

To view terminated Global users:

  1. Select Users from the menu bar. The Global Users page is displayed.

  2. Select the sponsor company from the Current Sponsor Company drop-down list. The list of Global users for the selected sponsor company is displayed.

  3. Click the Terminated User List link. The Global User Terminated List page is displayed, which shows the list of terminated users.

  4. To go back to the previous page, click Return.

3.5.7 Unterminating Global Users

The Terminated User List page lets you revoke the termination of Global users. You can either revoke the termination of all users or a particular user.

To unterminate Global users:

  1. Select Users from the menu bar. The Global Users page is displayed.

  2. Select the sponsor company from the Current Sponsor Company drop-down list. The list of Global users for the selected sponsor company is displayed.

  3. Click the Terminated User List link. The Global User Terminated List page is displayed.

  4. Select the check box corresponding to the user whose termination you want to revoke and click Unterminate.

  5. Click OK in the dialog box that appears on revoking the termination of the InForm user.

  6. To go back to the previous page, click Back.

3.6 Merging Duplicate Users

You may have the same user registered with a different user name for a different trial under the same sponsor. This results in many duplicate users. The Merge Duplicate Users page lets you merge these duplicate users under one master user. After you select one record as the master user, the others are automatically terminated.

To view and merge duplicate users:

  1. Select Users from the menu bar. On the page that appears, select the sponsor company from the Current Sponsor Company drop-down list.

  2. Click Merge Duplicate Users.

  3. To filter duplicate users, enter the filter criteria and click Find. The list of users that satisfy the specified filter criteria is displayed.

  4. Select the check boxes corresponding to the users you want to merge and click Merge.

  5. The Merge Duplicate users page is displayed.

  6. Select the record you want as the Master User.

  7. Select the check boxes corresponding to the users you want to merge. Select Merge Selected Users from the Select drop-down list.

  8. Enter the reasons for change in the Comments text box. Click Save to merge the changes.

  9. Click OK on the dialog box that appears on successfully merging the duplicate records.

  10. Click Return to go back to the Merge Duplicate Users page.

Note:

Click Group Duplicate Users to display possible duplicate users without entering any filter criteria.

3.7 Linking Users

 The Link Users functionality also lets you manage duplicate users by linking one or more users with similar details. However, after the linking process is complete, the remaining users are not automatically terminated.

To view and link duplicate users:

  1. Select Users from the menu bar. On the page that appears, select the sponsor company and trial from the Current Sponsor Company and Trial drop-down lists.

  2. Click Link Users.

  3. The list of users that satisfy the specified linking criteria is displayed.

  4. Click the Link User link corresponding to the user you want to link to another user. The Updating Link Users page is displayed.

  5. Select the check boxes corresponding to the user you want to link the selected user to and enter the reasons for change in the Comments text-box.

  6. Click Update to link the users.

  7. Click OK on the dialog box that appears on successfully linking the duplicate users.

  8. Click Return to go back to the Link Users page.