Siebel Clinical Trial Management System Guide > Setting Up Clinical Trials >

Setting Up Clinical Protocols

Multiple protocols can be associated with a program. When you have created a protocol record, you can also add extra information about the protocol, such as financial information, central lab information, and so on.

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

To set up a clinical protocol

1. Navigate to the Administration - Clinical screen, then the Protocol List view.
2. In the Protocol list, create a new record and complete the necessary fields.

   Some fields are described in the following table.

   Field	Comments
   # Planned Sites	Number of sites planned for the protocol.
   # Planned Subjects	Number of subjects planned for the protocol.
   Actual End Date	The date on which the study concludes.
   Actual Start Date	The date on which the study begins.
   Approval Date	The date on which the protocol was approved by the regulatory authority.
   Central Lab	The name of the laboratory associated with the study. This is entered through the Accounts screen.
   CRO	Name of the clinical research organization that is sponsoring the trial.
   Currency Code	The currency that is used to display the payments, costs, and budgets for the protocol. The default value is USD (United States dollars). NOTE:  You must specify the Currency Code for the protocol.
   Design	Information about the type of study.
   Exchange Date	The date that determines the exchange rate of the currency used. By default, the exchange date for the protocol is the date the protocol is created.
   Objective	The objective for the clinical trial.
   Phase	Phase of clinical trial, such as Phase I, II, or III.
   Planned End Date	The planned end date for the study.
   Planned Start Date	The planned start date for the study.
   Product	Only products that have been associated with the clinical program, through the Application field in the Program List view, can be selected from the Clinical Product and Indication dialog box. For more information about creating a clinical program, see Creating Clinical Programs.
   Program	Name of the program for the clinical trial.
   Protocol #	Identifying number assigned to the protocol.
   Regions Required	The flag to indicate the sites for this protocol must belong to a region. For information about regions, see Setting Up Clinical Regions. When this field is selected, you cannot create sites directly under protocols. You must create regions first and then create sites that are associated with regions.
   Sponsor	The clinical trial sponsor.
   Status	The status of the protocol, such as planned, in progress, or completed.
   Team	Enter the names of those who need access to the protocol, the study manager and others who monitor the clinical trial. For more information, see Step 3.
   Title	Descriptive title for the protocol.
   Type	Purpose of the protocol.
   Withholding Amount	The amount to be withheld from each of the payments to the investigators until the trial is complete. This value can be overwritten at the region and site levels.
   Withholding %	The percentage to be withheld from each of the payments to the investigators until the trial is complete. This value can be overwritten at the region and site levels.

3. To add team members to the protocol, click the select button in the Team field to open the Team dialog box, and complete the following steps:
   1. Move the record for an available team member to the list of selected team members.
   2. Click Position Rolldown.

      Multi-selected team members are added to the protocol as well as to all regions and sites belonging to the protocol.

   3. Click OK.

      Each time a member is added to the team of a protocol, a tracking record is created in the Team History view with a proper start date for this Tracking record. For more information, see About Automatically Assigning Team Members to a Protocol Using the Position Rolldown Button.

      If a member is removed from the team of a protocol, then the end date of this record is automatically filled in. For more information, see About Removing Team Members From the Team of a Protocol.

4. Drill down on the protocol number field, and navigate to the More Info view to add more information.
5. Drill down on the protocol number field, and navigate to the Team History view to view the details of the team member that was automatically added to the protocol in the previous step.

   From the Team History view you can administer and track team members who have worked on the protocol. It also provides details about what the role was as well as the start and end dates. To administer and track the history of team members who have worked on a protocol and to determine what their role was, see Tracking and Revising Team Assignment History.