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
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Click the Tasks icon on the application taskbar to open the Task Pane applet for Siebel Clinical.
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Click Create Protocol in the Task Pane applet.
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Enter protocol data on the page that appears:
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Fields to complete are described in Creating Protocols.
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Select the Regions Required check box.
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Click Submit.
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Click Yes when prompted with the following question: Do you want to create Region now?
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Click Submit.
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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.
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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.
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If required, click Cancel at any time to cancel the task.
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Click Submit to submit the task - that is, create the new protocol and region.