Siebel Life Sciences Guide > Setting Up and Carrying Out a Clinical Trial > End-User Procedures >

Adding a Site

The site is the group at an account, headed by a principal investigator, who carries out a particular protocol. In Siebel eClinical, a separate site record must exist for each unique combination protocol, account, and principal investigator.

To add a site

  1. Navigate to the Site Management screen.
  2. From the Show drop-down list, select My Sites.
  3. In the Sites list, add a record, and complete the necessary fields. (To access more fields, click the show more button in the form.)

    4. Some of the fields in a Sites record are described in the following table.

    Field
    Comments
    Account
    The institution where the protocol is to be carried out.
    Address
    Select one of the principal investigator's addresses as the site address.
    Currency Code
    The currency that is used to display the payments, costs, and budgets for the site.
    Exchange Date
    The date that determines the exchange rate of the currency used. By default, the exchange date for the site is the date the site is created.
    This date may be changed in response to changes in currency rates. However, changes made to the exchange date at the site level take effect only when the exchange date also changes at the system level. For more information, see Applications Administration Guide.
    PI Last Name
    Last name of the principal investigator.
    If an account has already been specified for the site, use Affiliated Contacts in the Pick Contacts dialog box to view only those who are affiliated with the account.
    Protocol #
    Select from list of existing protocols in the Pick Protocol dialog box.
    Region
    If regions are required for this protocol, enter a region name.
    Status
    Planned, Initiated, Enrolling, Closed
    The choices in this drop-down list are configured by using the CLNCL_PROTOCOL_SITE_STATUS type in the List of Values.
    Team
    The Primary flag defaults to the creator of the site record. The flag can only be changed by the manager of the team through the My Team's Sites view. This is consistent with the best practice because resource management is normally a manager's responsibility.
    See Step 4 for information on entering.
    Version
    See Step 5 for information on entering.

  4. To enter team members, click the select button in the Team field, select a team member in the Team picklist, and click Position Rollup.

    5. The team member is automatically added to the region that the site belongs to, if the region required flag is checked, and to the protocol to which the site belongs.

  5. Enter a version for the subject visit template to be used at the site.
    1. In the Version field, click the select button to open the Template Versions dialog box.
    2. Click New.
    3. Select the protocol and version template you want to use to create subject visit schedules for the site, and click OK.

      4. The template versions are filtered to display only those related to your protocol.

    4. Enter the IRB Approval Date for the selected version.

      5. The template version cannot be activated without the IRB approval date.

    5. Click the Active field to make the selected version the active version at the site.

      6. Only one version can be active at a time. The active template is used when activities are generated for a subject.

      NOTE:  The IRB Approval Date must be entered before the template can be activated.

    6. Close the Template Versions dialog box.
  6. Add records for the principal investigator and other key site personnel.

    7. For information, see To associate contacts with a site.


 Siebel Life Sciences Guide 
 Published: 18 April 2003