12Siebel Clinical Task-Based UI

Siebel Clinical Task-Based UI

This chapter describes the task-based user interface for Siebel Clinical which CRAs (clinical research associates) use to manage protocols, regions, and sites for clinical studies. It includes the following topics:

• About Siebel Clinical Task-Based UI

• Activating Siebel Clinical Task-Based UI

• Accessing Siebel Clinical Task-Based UI

• Assigning Responsibilities to Predefined Task-Based UI Clinical Tasks

• Creating Protocols

• Creating Protocols and Regions

• Creating Sites

• Creating Site Contacts

• Creating Activity Plans for Sites

• Creating Activity Plans for Existing Protocols

• Creating Activity Plans for Existing Regions

• Creating RACT Assessments for Sites

• Creating RACT Assessments for Existing Protocols

• Creating RACT Assessments for Existing Regions

• Creating RACT Assessments for Existing Programs

• Administering Inbox Tasks

Note: Siebel Clinical task-based UI is available in Siebel CRM 20.7 Update and later releases.

About Siebel Clinical Task-Based UI

There are many tasks that CRAs perform in Siebel Clinical to manage protocols, regions, and sites for clinical studies. These tasks involve going to multiple screens in Siebel Clinical and performing subtasks in a specific order, which can be very time consuming and confusing for CRAs unfamiliar with the process. The purpose of Siebel Clinical task-based UI is to ensure a standard process for managing studies and site entries across an organization whereby when users open the task-based UI, they can navigate (forward and backward) through multiple screens to perform key clinical tasks and pause and resume job tasks as required. Validation is used to enforce any rules required by business processes – for example, you can create a site with or without a region.

The task-based UI for Siebel Clinical guides you through a series of steps to complete the following key clinical tasks:

1. Create a Protocol.

2. Create a Protocol and Region.

3. Create a Site.

4. Create Site Contacts.

5. Create Activity Plans for sites, exiting protocols, and existing regions.

6. Create Risk Assessments for sites, existing protocols, existing regions, and existing programs.

7. Go to Inbox to review inbox tasks, transfer tasks, and delete tasks as required.

Activating Siebel Clinical Task-Based UI

The following procedure shows how to activate the task-based UI for Siebel Clinical.

To activate Siebel Clinical task-based UI

1. In Siebel Clinical, navigate to the Administration - Business Process screen, then the Task Deployment view.

2. In the Published Tasks list, query for LS Clinical* in the Name field.

3. Click Activate (in the Published Tasks list).

   Siebel CRM validates the format and then changes the deployment status of the LS Clinical* task UI to Active.

4. Go to the Active Tasks list and verify that the Deployment Status field of the LS Clinical* task UI displays a value of Active.

Accessing Siebel Clinical Task-Based UI

The following procedure shows how to access the task-based UI for Siebel Clinical.

To access Siebel Clinical task-based UI

1. Click Tasks on the application taskbar to open the Tasks applet for Siebel Clinical.

2. In the Tasks applet, the following predefined clinical tasks are available:

   1. Create Protocol. Click to create a new protocol and (if required) region:

      • Creating Protocols

      • Creating Protocols and Regions

   2. Create Site. Click to create a new site - see Creating Sites.

   3. Other Site Tasks. Click to perform the following tasks on new or existing sites:

      • Creating Site Contacts

      • Creating Activity Plans for Sites

      • Creating RACT Assessments for Sites

   4. Other Protocol Tasks. Click to perform the following tasks on existing protocols:

      • Creating Activity Plans for Existing Protocols

      • Creating RACT Assessments for Existing Protocols

   5. Other Region Tasks. Click to perform the following tasks on existing regions:

      • Creating Activity Plans for Existing Regions

      • Creating RACT Assessments for Existing Regions

   6. Other Program Tasks. Click to perform the following task on existing programs:

      • Creating RACT Assessments for Existing Programs

3. Click Go to Inbox to go to the Inbox Items List view where you can resume work on paused tasks, transfer tasks, and delete tasks - see Administering Inbox Tasks.

Assigning Responsibilities to Predefined Task-Based UI Clinical Tasks

By default, Siebel Clinical administrators can access all the predefined task-based UI clinical tasks. To assign another responsibility to one or all of the predefined clinical tasks, then complete the steps in the following procedure.

To assign a responsibility to a predefined task-based UI clinical task

1. Navigate to the Administration – Application screen, then the Tasks view.

2. In the Registered Tasks list, query for LS Clinical* in the Task Name field. The following list of Registered tasks for Siebel Clinical returns.

   • LS Clinical TUI Create New Protocol

   • LS Clinical TUI Create New Site

   • LS Clinical TUI Create Other Site Task

   • LS Clinical TUI Protocol Tasks

   • LS Clinical TUI Program Other Tasks

   • LS Clinical TUI Region Other Tasks

   Notice that the Siebel Administrator responsibility (with Allow Delete and Allow Transfer permission) is assigned to each of these tasks by default.

3. Do the following to assign a new responsibility to, for example, the LS Clinical TUI Create New Site task:

   1. In the Registered Tasks list, select LS Clinical TUI Create New Site.

   2. In the Responsibilities list, click the plus (+) icon and then query for Clinical* in the Name field.

   3. Select Clinical Manager and then click OK.

   The Clinical Manager responsibility (with Allow Delete and Allow Transfer permission) now appears in the Responsibilities list for LS Clinical TUI Create New Site.

4. Repeat step 3, as required, to add other responsibilities to LS Clinical* tasks.

Creating Protocols

The following procedure shows how to create a protocol using Siebel Clinical task-based UI.

To create a protocol

1. Click Tasks on the application taskbar to open the Tasks applet for Siebel Clinical.

2. Click Create Protocol in the Tasks applet.

3. Enter protocol data on the page that appears - the fields are described in the following table.

   Field	Description
   Program	Select the name of the program for the clinical trial.
   Product	Select the product for the clinical trial. You can select only the products that are associated with the clinical program.
   # Planned Sites	Type the number of planned sites for the protocol.
   # Planned Subjects	Type the number of planned subjects for the protocol.
   Regions Required	Select this check box only if the sites for the protocol must belong to a region (and see Creating Protocols and Regions for more information). When you select this check box, you cannot create sites directly under protocols. You must create regions first, and then create sites that are associated with regions. Deselect this check box to indicate that the sites for this protocol must not belong to a region.
   Protocol #	Type an identifying number for the protocol.
   Phase	Select the phase of clinical trial, such as, Phase I, II, or III.
   Status	Select the protocol status, such as, Planned, In Progress, or Completed.
   Type	Select the purpose of the protocol.
   Title	Type a descriptive title for the protocol.

4. If required, click Pause at any time to pause the task.

   The task moves to your Inbox where you must go when you want to resume work on the task.

5. If required, click Cancel at any time to cancel the task.

6. Click Submit to submit the task - that is, create the new protocol.

Creating Protocols and Regions

The following procedure shows how to create a protocol and region using Siebel Clinical task-based UI.

To create a protocol and region

1. Click Tasks on the application taskbar to open the Tasks applet for Siebel Clinical.

2. Click Create Protocol in the Tasks applet.

3. Enter protocol data on the page that appears:

   • Fields to complete are described in Creating Protocols.

   • Select the Regions Required check box.

4. Click Submit.

5. Click Yes when prompted with the following question: Do you want to create Region now?

6. Click Submit.

7. Enter regional data on the page that appears - the fields are described in the following table.

   Field	Description
   Region	Select the geographical region to which the protocol belongs.
   Protocol Region	Displays the name of the region. This field is automatically populated with the protocol number and region name.
   Status	Select the region status. Options include Planned, In Progress, Completed, or Terminated,
   Central Lap	Select the Account name to assign the associated central lab.
   CRO	Select the Account name to assign the associated CRO.
   # Planned Sites	Type the number of planned sites for the region.
   # Planned Subjects	Type the number of planned subjects for the region.
   Currency Code	Select the currency that will be used to display the payments, costs, and budgets for the region. The default value is USD (US dollars).
   Withholding Amount	Type the amount to withhold from each of the payments to the investigators until the trial completes.
   Withholding Percent (%)	Type the percentage to withhold from each of the payments to investigators until the trial is complete.
   Exchange Date	Select the date that determines the exchange rate of the currency. By default, the exchange date for the region is the date that you create the region.
   No Site Info	Select this option to indicate that no site information will be available under the region. In such cases, only summary information about site enrolment will be available for the region. Deselect this option to indicate that site information will be available under the region.

8. If required, click Pause at any time to pause the task.

   The task moves to your Inbox where you must go when you want to resume work on the task.

9. If required, click Cancel at any time to cancel the task.

10. Click Submit to submit the task - that is, create the new protocol and region.

Creating Sites

The following procedure shows how to create a site using Siebel Clinical task-based UI.

To create a site

1. Click Tasks on the application taskbar to open the Tasks applet for Siebel Clinical.

2. Click Create Site in the Tasks applet.

3. Enter site data on the page that appears - the fields are described in the following table.

   Field	Description
   Protocol #	Type an identifying number for the protocol.
   Region	Select the geographical region to which the site belongs.
   Site #	Type the number to assign to the site.
   PI Last Name	Select the last name of the principal investigator for the site.
   PI First Name	The first name of the principal investigator for the site (read-only field).
   # Planned Subjects	Type the number of planned subjects for the protocol.
   SDV Policy	Select the Source Data Verification Policy.
   Activity Plans	Select Yes if you want to create activity plans for this site, otherwise select No.
   Site Contacts	Select Yes if you want to create contacts for this site, otherwise select No.
   RACT Assessment	Select Yes if you want to create risk assessments for this site, otherwise select No.

4. If required, click Pause at any time to pause the task.

   The task moves to your Inbox where you must go when you want to resume work on the task.

5. If required, click Cancel at any time to cancel the task.

6. Click Submit to do one of the following:

   1. Submit the task - that is, create the site.

   2. Create site contacts, activity plans, and/or risk assessments for the site. For more information, see the following topics:

      • Creating Site Contacts
      • Creating Activity Plans for Sites
      • Creating RACT Assessments for Sites

Creating Site Contacts

The following procedure shows how to create a site contact using Siebel Clinical task-based UI.

To create a site contact

1. Click Tasks on the application taskbar to open the Tasks applet for Siebel Clinical.

2. Complete one of the following to create a site contact for a new or an existing site:

   1. To create a site contact for a new site:

      • Click Create Site in the Tasks applet.

      • Enter site data on the page that appears - all fields are described in Creating Sites.

      • Select Yes for Site Contacts and then click Submit.

   2. To create a site contact for an existing site:

      • Click Other Site Tasks in the Tasks applet.

      • Select the record that you want in the Sites list and then click Submit.

      • Select Yes for Site Contacts and then click Submit.

3. Enter site contact details on the page that appears - some fields are described in the following table.

   Field	Description
   Role	The role of the contact.
   Last Name	The first name of the contact.
   First Name	The last name of the contact.
   Start Date	The date when the contact record is active.
   Address	The address for the contact.
   City	The city where the contact is located.
   State	The state where the contact is located.
   Postal Code	The postal code for the contact's address.
   Country	The country where the contact is located.
   Main Phone	The phone number for the contact.
   E-Mail	The email address for the contact.

4. If required, click the plus (+) icon to create additional site contacts.

5. If required, click Pause at any time to pause the task.

   The task moves to your Inbox where you must go when you want to resume work on the task.

6. If required, click Cancel at any time to cancel the task.

7. Click the check box next to each contact that you want to associate with the site and then click Submit to submit the task - that is, create the site contact(s).

Creating Activity Plans for Sites

The following procedure shows how to create activity plans for a site using Siebel Clinical task-based UI.

To create an activity plan for a site

1. Click Tasks on the application taskbar to open the Tasks applet for Siebel Clinical.

2. Complete one of the following to create an activity plan for a new or an existing site.

   1. To create an activity plan for a new site:

      • Click Create Site in the Tasks applet.

      • Enter site data on the page that appears - all fields are described in Creating Sites.

      • Select Yes for Activity Plans and then click Submit.

   2. To create an activity plans for an existing site:

      • Click Other Site Tasks in the Tasks applet.

      • Select the record that you want in the Sites list and then click Submit.

      • Select Yes for Activity Plans and then click Submit.

3. Enter activity plan details on the page that appears - some fields are described in the following table.

   Field	Description
   Planned Start	Select the date and time to start the activity plan.
   Templates	Select the template for the activity plan.
   Description	This field is automatically populated when you select a template for the activity plan.
   Lock Assignment	Lock the assignment as required by selecting this field.

4. If required, click the plus (+) icon to create additional activity plans.

5. If required, click Pause at any time to pause the task.

   The task moves to your Inbox where you must go when you want to resume work on the task.

6. If required, click Cancel at any time to cancel the task.

7. Click the check box next to each activity plan that you want to associate with the site and then click Submit to submit the task - that is, create the activity plan(s) for the site.

Creating Activity Plans for Existing Protocols

The following procedure shows how to create activity plans for existing protocols using Siebel Clinical task-based UI.

To create an activity plan for an existing protocol

1. Click Tasks on the application taskbar to open the Tasks applet for Siebel Clinical.

2. Click Other Protocol Tasks in the Tasks applet.

3. Select the record that you want in the Protocols list and then click Next.

4. Select Yes for Activity Plans and then click Next.

5. Enter activity plan details on the page that appears - all fields are described Creating Activity Plans for Sites.

6. If required, click the plus (+) icon to create additional activity plans.

7. If required, click Pause at any time to pause the task.

   The task moves to your Inbox where you must go when you want to resume work on the task.

8. If required, click Cancel at any time to cancel the task.

9. Click the check box next to each activity plan that you want to associate with the protocol and then click Submit to submit the task - that is, create the activity plan(s) for the protocol.

Creating Activity Plans for Existing Regions

The following procedure shows how to create activity plans for existing regions using Siebel Clinical task-based UI.

To create an activity plan for an existing region

1. Click Tasks on the application taskbar to open the Tasks applet for Siebel Clinical.

2. Click Other Region Tasks in the Tasks applet.

3. Select the record that you want in the Regions list and then click Submit.

4. Select Yes for Activity Plans and then click Submit.

5. Enter activity plan details on the page that appears - all fields are described Creating Activity Plans for Sites.

6. If required, click the plus (+) icon to create additional activity plans.

7. If required, click Pause at any time to pause the task.

   The task moves to your Inbox where you must go when you want to resume work on the task.

8. If required, click Cancel at any time to cancel the task.

9. Click the check box next to each activity plan that you want to associate with the region and then click Submit to submit the task - that is, create the activity plan(s) for the region.

Creating RACT Assessments for Sites

The following procedure shows how to create risk assessments for a site using Siebel Clinical task-based UI.

To create a risk assessment for a site

1. Click Tasks on the application taskbar to open the Tasks applet for Siebel Clinical.

2. Complete one of the following to create a risk assessment for a new or an existing site.

   1. To create a risk assessment for a new site:

      • Click Create Site in the Tasks applet.

      • Enter site data on the page that appears - all fields are described in Creating Sites.

      • Select Yes for RACT Assessment and then click Submit.

   2. To create a risk assessment for an existing site:

      • Click Other Site Tasks in the Tasks applet.

      • Select the record that you want in the Sites list and then click Submit.

      • Select Yes for RACT Assessment and then click Submit.

3. Enter risk assessment details on the page that appears as follows:

   • In the Assessments Templates applet, select the assessment template in the Template Name field.

   • If required, click the plus (+) icon to create additional assessment template records.

   • In the Assessment Questions applet, complete the necessary fields for each question that you want to assess. For more information, see Creating Risk Assessment Templates.

4. If required, click Pause at any time to pause the task.

   The task moves to your Inbox where you must go when you want to resume work on the task.

5. If required, click Cancel at any time to cancel the task.

6. Click the check box next to each assessment template and assessment question that you want to associate with the site and then click Submit to submit the task - that is, create the risk assessment(s) for the site.

Creating RACT Assessments for Existing Protocols

The following procedure shows how to create risk assessments for existing protocols using Siebel Clinical task-based UI.

To create a risk assessment for an existing protocol

1. Click Tasks on the application taskbar to open the Tasks applet for Siebel Clinical.

2. Click Other Protocol Tasks in the Tasks applet.

3. Select the record that you want in the Protocols list and then click Next.

4. Select Yes for RACT Assessment and then click Next.

5. Enter risk assessment details on the page that appears as follows:

   • In the Assessments Templates applet, select the assessment template in the Template Name field.

   • If required, click the plus (+) icon to create additional assessment template records.

   • In the Assessment Questions applet, complete the necessary fields for each question that you want to assess. For more information, see Creating Risk Assessment Templates.

6. If required, click Pause at any time to pause the task.

   The task moves to your Inbox where you must go when you want to resume work on the task.

7. If required, click Cancel at any time to cancel the task.

8. Click the check box next to each assessment template and assessment question that you want to associate with the protocol and then click Submit to submit the task - that is, create the risk assessment(s) for the protocol.

Creating RACT Assessments for Existing Regions

The following procedure shows how to create risk assessments for existing regions using Siebel Clinical task-based UI.

To create a risk assessment for an existing region

1. Click Tasks on the application taskbar to open the Tasks applet for Siebel Clinical.

2. Click Other Region Tasks in the Tasks applet.

3. Select the record that you want in the Regions list and then click Submit.

4. Select Yes for RACT Assessment and then click Submit.

5. Enter risk assessment details on the page that appears as follows:

   • In the Assessments Templates applet, select the assessment template in the Template Name field.

   • If reqruied, click the plus (+) icon to create additional assessment template records.

   • In the Assessment Questions applet, complete the necessary fields for each question that you want to assess. For more information, see Creating Risk Assessment Templates.

6. If required, click Pause at any time to pause the task.

   The task moves to your Inbox where you must go when you want to resume work on the task.

7. If required, click Cancel at any time to cancel the task.

8. Click the check box next to each assessment template and assessment question that you want to associate with the region and then click Submit to submit the task - that is, create the risk assessment(s) for the region.

Creating RACT Assessments for Existing Programs

The following procedure shows how to create risk assessments for existing programs using Siebel Clinical task-based UI.

To create a risk assessment for an existing program

1. Click Tasks on the application taskbar to open the Tasks applet for Siebel Clinical.

2. Click Other Program Tasks in the Tasks applet.

3. Select the record that you want in the Programs list and then click Submit.

4. Select Yes for RACT Assessment and then click Submit.

5. Enter risk assessment details on the page that appears as follows:

   • In the Assessments Templates applet, select the assessment template in the Template Name field.

   • If required, click the plus (+) icon to create additional assessment template records.

   • In the Assessment Questions applet, complete the necessary fields for each question that you want to assess. For more information, see Creating Risk Assessment Templates.

6. If required, click Pause at any time to pause the task.

   The task moves to your Inbox where you must go when you want to resume work on the task.

7. If required, click Cancel at any time to cancel the task.

8. Click the check box next to each assessment template and assessment question that you want to associate with the program and then click Submit to submit the task - that is, create the risk assessment(s) for the program.

Administering Inbox Tasks

You can pause a clinical task at any time and resume work on the task, as required, by going to the the Inbox Items List view of Siebel Clinical task-based UI. You can also delete and transfer tasks in the Inbox Items List view as shown in the following procedure.

To administer Inbox tasks for Siebel Clinical task-based UI

1. Click Tasks on the application taskbar to open the Tasks applet for Siebel Clinical.

2. Click Go to Inbox in the Tasks applet.

   The Inbox Items List view appears.

3. To resume work on a task:

   1. Drill down on the task (Name field) that you want to resume work on.

   2. Resume work on the task and complete the task as required.

4. To transfer a task:

   1. Select a task in the Inbox Items List.

   2. Click Transfer.

   3. In the Transfer To dialog that appears, select the user to whom you want to transfer the task.

   4. Enter a comment in the Comments box to notify the user and then click OK.

5. To delete a task:

   1. Select a task in the Inbox Items List.

   2. Click Delete Task.