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Creating a Clinical Protocol Site Template


Activities can be associated directly with sites. For example, all sites carrying out the same protocol need to perform similar site initiation activities and submit similar documents to the regulatory agencies. When many activities are common to multiple sites, the clinical protocol site template helps CRAs create site activities.

The clinical site protocol template is one of a number of activity templates used in Siebel eClinical. Others are subject visit templates (Defining a Subject Visit Template), trip report templates (Creating a Trip Report Template), contact assessment templates (Creating an Assessment Template).

NOTE:  Unlike trip report templates, clinical protocol site templates are protocol-specific. To use a clinical site template in association with more than one protocol, duplicate the record and then edit the Protocol Title field.

To create a clinical protocol site template

  1. From the application-level menu, choose View > Site Map > Application Administration > Activity Templates.
  2. In the Activity Templates list, add a record, and complete the necessary fields.
  3. Some of the fields in an Activity Template record are described in the following table.

    Field
    Comments
    Auto Trigger, Public, Sales Method, Sales Stage
    Typically, these fields are not used in a clinical protocol site template.
    Protocol Title
    The protocol with which the clinical protocol site template will be used. This field must be completed.
    Type
    Must be Clinical Protocol Site.

  4. Click the Activity Template Details view tab.
  5. In the Activity Template Details list, add a record, and complete the necessary fields.
  6. Some of the fields in an Activity Template Details record are described in the following table.

    Field
    Comments
    Activity
    The choices in this drop-down list are configured by using the TODO_TYPE type in the List of Values.
    For document tracking, use either Document or Site Initiation.
    Budgeted Cost, Cost Estimate
    Typically, these fields are not used in a clinical protocol site template.
    Lead
    The time after the planned start date when the activity is due.
    Priority
    The choices in this drop-down list are configured by using the ACTIVITY_PRIORITY type in the List of Values.
    Status
    Leave this field blank or set it to a value such as Planned, Not Started, or Auto-Created.
    The choices in this drop-down list are configured by using the EVENT_STATUS type in the List of Values.
    Type
    The choices in this drop-down list are configured by using the TODO_TYPE type in the List of Values and setting the Parent LIC to the activity type.
    Units
    Units for lead time.

  7. Add a record for each activity that you want to appear in the template.

 Siebel Life Sciences Guide 
 Published: 18 April 2003