Siebel Life Sciences Guide > Setting Up and Carrying Out a Clinical Trial >

Creating a Site (End User)

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

To create a site

1. Navigate to the Site Management screen > Protocol Site List view.
2. In the Sites list, create a new record and complete the necessary fields.

   Some fields are described in the following table.

   Field	Comments
   Account	The institution where the protocol is to be carried out.
   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 Siebel Applications Administration Guide.
   No Subject Info	Check this flag when there is no subject information available for a site. Only summary information on subject enrollment is available for such a site.
   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.
   Site #	The number that is to be assigned to the site. The Site # field is not required when the site status is Planned or Not Initiated. The Site # field becomes required after a site has been initiated.
   Status	Planned, Initiated, Enrolling, and Closed. A state model is preconfigured to make sure structured state transition.
   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 3 for information on entering.
   Versions	See Step 4 for information on entering.
   Withholding Amount	The amount of the total payment to be withheld from the investigators until the trial is complete. The default value is that of the region or protocol, but can be overwritten at the Site level.
   Withholding Percentage	The percentage of the total payment to be withheld from the investigators until the trial is complete. The default value may be set at the region or protocol level, but can be overwritten at the Site level.

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

   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.

4. Click the select button in the MVG Version field and do the following:
   1. Enter the version for the subject visit template to be used at the site.

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

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

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

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

      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.

      For more information about protocol versions, see Creating and Revising Protocol Versions.

5. Create records for the principal investigator and other key site personnel.

   For information, see To associate contacts with a site.

6. (Optional) Drill down on the Site # field and add extra information using the More Info tab view.

   Some fields are described in the following table.

   Field	Comments
   Address	Select one of the principal investigator's addresses as the site address.
   Contract Amount	Lists the sum of all contract amounts for the site. This field is read-only. For more information, see Associating Contracts with a Site.
   # Early Terminated	The number of subjects who have terminated the study before it has been completed.
   Earned To Date	The amount of money earned to date by the investigators.
   First Subject Enrolled	The date that the first subject was enrolled to the study. (This field is automatically rolled-up from the subject data.)
   Last Subject Off Study	The date that the last of the subjects has completed the study. (This field is automatically rolled-up from the subject data.)
   Paid To Date	The amount of money paid to date to the investigators.
   #Screen Failure	Number of subjects that have failed the screening.