Managing Clinical Projects

This chapter describes how to manage clinical projects. It includes the following topics:

About Managing Clinical Projects

This chapter supplements other information about project management. For information about project management, see Siebel Project and Resource Management Administration Guide.

Projects in Siebel Clinical help project managers manage projects for clinical trials, and are associated with individual protocols. From the Projects screen, you can enter, view, and update timelines, milestones, costs, and resources.

Scenario for Managing Clinical Projects

This topic gives one example of how to manage clinical projects. You might manage clinical projects differently, depending on your business model.

This topic includes the following information:

Setting Up and Staffing the Project

A product manager works for a large CRO (clinical research organization) that has a contract to carry out a clinical trial for a pharmaceutical company. He is responsible for setting up and running the project for a clinical trial.

First, the product manager enters some basic information about the project into Siebel Clinical, and determines the employees that can access the project data by entering them in the project access list.

To optimize the resource assignment, the product manager enters the resource requirements in the team workbook, and then uses Siebel Assignment Manager to help with the staffing. He specifies the roles, skills, competencies, and availability required for the team, and lets Resource Manager find the best candidate for the roles.

For this large project, the CRO might need some subcontractors to complete certain aspects of the project. Because the subcontractors are paid at an hourly rate, the product manager associates the appropriate billing rate list with the project. He also must add employees of the subcontracting company to the subcontractor resource list.

The product manager can add other external contacts and accounts to the project. For example, he can add information about the central laboratory and the primary contact at this laboratory.

Managing Tasks, Activities, and Risks

You can set milestones as tasks or activities. The product manager can create milestones within projects in Siebel Clinical. Each Siebel activity has a budget, and end users update the actual costs of these activities as the project progresses. Periodically, the product manager reviews these project costs, making sure that the project stays within budget. Payments you make to sites for subject activities are rolled up to the project costs.

You document project risks as they arise, and you document the resolution activities to address the risks.

Process of Managing Clinical Projects

This topic details sample tasks that administrators and end users often perform when managing clinical projects. Your company might follow a different process according to its business requirements.

Perform the administrative tasks described in this topic before performing the related end-user tasks.

Administrator Tasks

The tasks that an administrator must complete to support projects depends on the project features that the organization uses. You might not have to perform all the tasks listed in this topic. These tasks must occur before the project manager creates the project.

The following list shows the tasks administrators typically perform to manage clinical projects:

Creating Activity Templates for Clinical Projects. Many project managers use these templates to carry out similar clinical trials.
Setting Up Employee Profiles for Clinical Projects. Maintain the employee profiles of skills and competencies that Siebel Assignment Manager uses.
Setting Up Position Types and Rate Lists for Billing. The position types and rate lists are required to allow subcontractors (and employees) to bill the project for their time.

End-User Procedures

The following list shows the tasks end users typically perform to manage clinical projects:

Creating Clinical Projects. You associate protocols with projects.
Associating People and Accounts with Clinical Projects. Give employees access to the project; add contacts and accounts to the project team workbook.
Creating Activities and Tasks for Clinical Projects. Standalone activities are not associated with tasks.
Monitoring Costs for Clinical Projects. View costs for clinical projects.
Managing Risk for Clinical Projects. Document project risks and resolution activities.

Creating Activity Templates for Clinical Projects

You can create activities in the Projects screen. If the study managers primarily enter activities in the Projects screen, then creating activity templates for projects is advantageous.

To create an activity template for projects, you create an activity template with a Project type. The Protocol Type field is optional because you can apply the activity template to any project, regardless of the protocol associated with the project. In the Activity Template Details list, create records to describe activities and milestones for the project. For information about how to create activity templates, see Siebel Applications Administration Guide.

This task is a step in Process of Managing Clinical Projects.

Setting Up Employee Profiles for Clinical Projects

End users can use Siebel Assignment Manager to automatically search the employee database for the available employees whose skills best fit the needs of the project. Siebel Assignment Manager requires that you set up profiles of skills and competencies for employees. For information about using Siebel Assignment Manager, see Siebel Assignment Manager Administration Guide.

Use of Siebel Assignment Manager is not required. End users can assign team members directly into the Team Workbook view, without using Siebel Assignment Manager.

This task is a step in Process of Managing Clinical Projects.

Setting Up Position Types and Rate Lists for Billing

If project team members bill their time to the project through the Team Workbook view, then set position types and rate lists.

You set up position types, such as Consultant, as products, and you designate them as resources. You then set up lists of hourly rates for the position types. When you apply the rate list to the project, the hourly rates for the team members are automatically supplied in the team workbook. For more information about position types and rate lists for professional services, see Siebel Applications Administration Guide.

This task is a step in Process of Managing Clinical Projects.

Creating Position Types as Products

Complete the procedure in this topic to create position types as products.

To create position types as products

Navigate to the Administration - Product screen, then the Products view.

In the Products list, create a new record and complete the necessary fields.

Some fields are described in the following table.

Field	Comments
Product	Type the product (resource) name, for example, Consultant.
Project Resource	Select this field to indicate that the product is a project resource.

Creating Rate Lists

Complete the procedure in this topic to create a rate list.

To create a rate list

Navigate to the Administration - Pricing screen, then the Rate List view.
In the Rate Lists list, create a new record and complete the necessary fields.
In the Rate Lists list, drill down on the Rate List field.
In the Rate List Line Items list, create a new record.
In the Add Position Types dialog box, select the Position Type and click OK.
This list of resources is created as a product.
In the Rate List Line Items list, complete the remaining fields.

Creating Clinical Projects

You can create a project record and associate a protocol with the project.

Note: It is recommended that you associate a protocol with only one project. However, you are not prevented from associating a protocol with multiple projects. In this case, costs associated with payments to sites are rolled up to each project.

This task is a step in Process of Managing Clinical Projects.

To create a clinical project

Navigate to the Projects screen, then the List view.

In the Project list, create a new record and complete the necessary fields.

Some fields are described in the following table.

Field	Comments
Project ID	Type a unique identification number for the project.
Account	Select the account for the project. For example, select the name of the pharmaceutical company for which you carry out the project.
Start	Select the start date and time for the project.
End	Select the end date and time for the project.
Protocol #	Select the protocol for the project. All available protocols are available for selection from the Pick Protocol dialog box. The project creator does not have to be a member of the protocol team.
Actual Cost	Displays the actual cost of the project. This field is calculated by summing the actual costs of all the tasks, activities, and site payments associated with the project.
Revenue	Type the total revenue for the project. Click the currency calculator button for this field to enter the amount of revenue, the currency, and the exchange date for the currency.
Budgeted Cost	Displays the budgeted cost of the project. This field is calculated by summing the budgeted costs of all the tasks, activities, and site payments associated with the project.

Drill down on the Name field of the project, and navigate to the More Info view to add more information.

Some field are described in the following table.

Field	Comments
Rate List	Select the rate list for the project if a rate list is set up for the project team members. Click the show more button if this field is not visible. For more information, see Setting Up Position Types and Rate Lists for Billing.
Description	Type a description of the project.

Associating People and Accounts with Clinical Projects

You can give employees in Siebel Clinical access to the project and add them to the team workbook.

You can associate contacts with projects through the Contacts view and the Organizational Analysis view. The same contacts appear in the Contacts view and the Organizational Analysis view.

You can associate accounts with projects through the Partners view and the Subcontractors view. Adding accounts to the Subcontractors view allows you to add employees from the subcontracting accounts to the project team workbook. For more information about adding subcontractors, see Siebel Project and Resource Management Administration Guide.

This task is a step in Process of Managing Clinical Projects.

Adding Employees to Projects

Complete the procedure in this topic to add employees to a project.

To add employees to a project

Give employees access to a project by adding them to the Access view.
For more information about providing access to a project, see Siebel Project and Resource Management Administration Guide.
Allow end users to assign employees and subcontractors to activities, and allow employees and subcontractors to bill time to the project by adding them to the Team Workbook view.
If a rate list is set up, then make sure that the Resource field on the Resource Detail form of the Team Workbook view is set for the team members. For more information about the team workbook for project management, see Siebel Project and Resource Management Administration Guide.

Adding Contacts to Projects

Complete the procedure in this topic to add a contact to a project using the Organization Analysis view.

To add a contact to a project

Navigate to the Projects screen, then the List view.
In the Project list, drill down on the Name field of the project.
Navigate to the Organization Analysis view.
From the Organization Analysis drop-down list, select Contacts.
In the Contacts list, create a new record and complete the necessary fields.
From the Contacts drop-down list, select Organization Analysis.
An organization chart of the contacts appears. Any employee-manager relationships set in Step 5 are indicated.

Adding Partner Accounts to Projects

Complete the procedure in this topic to add a partner account to a project.

To add a partner account to a project

Navigate to the Projects screen, then the List view.
In the Project list, drill down on the Name field of the project.
Navigate to the Partners view.
In the Partners list, create a new record and complete the necessary fields.
The Site field is a unique identifier for the site of the account. This field is not related to the sites where you carry out clinical trials.

Creating Activities and Tasks for Clinical Projects

You can create activities for the project in the following ways:

Enter activities in the Activities view.
Generate activities in the Activity Plans view by applying an activity template to projects.
Manually enter activities in the Activity Plans view. These activities must be associated with an activity plan that is based on a template.
Create a task in the Task view and associate activities with the task.

A task is a container for activities. Activities associated with tasks are different from regular standalone activities. Activity templates for projects cannot generate activities that belong to tasks. You can only manually create these activities from within the Project Task Activity view. You cannot add a standalone activity to a task, nor can you disassociate an activity for a task from the task. For more information about creating activities and tasks for project management, see Siebel Project and Resource Management Administration Guide.

This task is a step in Process of Managing Clinical Projects.

Creating Activities for Projects

Complete the procedure in this topic to create an activity for a project using an activity template.

Note: You can also manually create activities in the Activities view.

To create an activity for a project

Navigate to the Projects screen, then the List view.
In the Project list, drill down on the Name field of the project.
Navigate to the Activity Plans view.
In the Activity Plans list, create a new record.
In the Template field, select a template from the drop-down list.
The activities associated with the activity plan appear in the Activities list.

Creating Tasks and Associated Activities

Complete the procedure in this topic to create a task and associated activities.

To create a task and associated activities

Navigate to the Projects screen, then the List view.
In the Project list, drill down on the Name field of the project.
Navigate to the Tasks view.
In the Tasks list, create a new record and complete the necessary fields.
In the Tasks list, drill down on the Name field.
In the Activities list, create a new record and complete the necessary fields.

Monitoring Costs for Clinical Projects

The Cost view provides you with a valuable summary of all costs associated with a particular project and protocol.

The cost items appear in the following lists:

Project Activities. Displays those records from the Activities view where the Cost field is selected.
Project Tasks. Displays those records from the Tasks view where the Cost field for the task is selected. The actual cost and budgeted cost for a task are determined by summing the costs of the activities contained in the task.
Clinical Payments. Displays payments made to the sites associated with the protocol. These payment amounts are rolled up into the Actual Cost field in the project record.

End users cannot create, modify, or delete records in the Costs view.

Note: All costs in this view are in the default currency set for the project.

This task is a step in Process of Managing Clinical Projects.

To monitor costs for clinical projects

Navigate to the Projects screen, then the List view.
In the Project list, drill down on the Name field of the project.
Navigate to the Costs view.
Click a hyperlink in the Clinical Payments or Project Tasks list to see the activities associated with a cost item.

Managing Risk for Clinical Projects

An important aspect of project management is risk management. The features of the Risks view allow you to enter information about project risks and create and assign resolution activities to address the risks. For more information about assessing risks for project management, see Siebel Project and Resource Management Administration Guide.

This task is a step in Process of Managing Clinical Projects.

To manage risk for clinical projects

Navigate to the Projects screen, then the List view.
In the Project list, drill down on the Name field of the project.
Navigate to the Risks view.
In the Risks list, create a new record and complete the necessary fields.
In the Risks list, drill down on the Name field.
In the Resolution Activities list, create a new record and complete the necessary fields.

About Views in the Projects Screen

Many views are available in the Projects screen of the Siebel Clinical. You can choose to use only some of these views. The following table describes the views that are available in the Projects screen.

Table Views in the Projects Screen

View	Comments
Access	Use this view to provide project access. Add the names of the project team members and also managers or executives who want access to monitor the progress of the project. The Access view has a similar function to the Team field in other screens.
Activities	Use this view to manage activities associated with the project. You might manually create activities in this view, or activity templates for projects might create these activities. Activities belonging to tasks do not appear in this view.
Activity Plans	Use this view to generate activities from activity templates for projects. You can manually add more activities to the activities already associated with an activity plan.
Attachments	Use this view to attach project documents. For general information about attachments, see Siebel Fundamentals.
Calendar	Use this view to manage a monthly calendar of the activities associated with the project. Activities belonging to tasks and standalone activities appear in this view. For general information about the calendar views, see Siebel Fundamentals.
Contacts	Use this view to maintain a list of contacts associated with the project. Enter names of employees in subcontracting or partner organizations.
Financial Profile	Use this view to gain an overall perspective of a project’s financial information, status, and progress. You can change the Delivery status for the project. For more information, see Siebel Project and Resource Management Administration Guide.
Invoices	Use this view to create invoices for time and expenses that apply to a project. For more information, see Siebel Project and Resource Management Administration Guide.
Notes	Use this view to keep private and public notes about the project. For general information, see Siebel Fundamentals.
Orders	Use this view to create a product or material order and associate it with the project. For more information, see Siebel Project and Resource Management Administration Guide.
Organizational Analysis	Use this view to see an organizational chart of contacts that shows the relationships between them.
Partners	Use this view to maintain a list of partner accounts associated with the project. You can keep a list of accounts associated with the project, such as vendors who handle printing of the clinical trial materials or shipping of sample drugs. Because the views for Partners, Subcontractors, and Clinical Contacts contain account information, you can use one or more of these views to keep track of accounts associated with a project.
Risks	Use this view to maintain a list of the risks associated with the project and resolution activities required to address those risks.
Status Report	Use this view to create a status report summarizing the project’s progress, forecast, and issues. For more information, see Siebel Project and Resource Management Administration Guide.
Subcontractors	Use this view to keep a list of subcontractors associated with the project. For more information, see the description of the Partners field.
Tasks	Use this view to create and modify tasks for the project.
Team Workbook	Use this view to assign team members to roles in the project. You can manually assign team members, or Siebel Assignment Manager can automatically assign them. Team members must be listed in the workbook before you can assign them to activities.
Time & Expense	Use this view to adjust and summarize time sheets and expense reports associated with the project. For more information about time sheets and expense reporting, see Siebel Project and Resource Management Administration Guide.