Maintaining Site Records

Oracle Clinical refers to the locations where patients receive treatment as sites. You create site records, then you assign them to studies. A study site is a site that has been assigned to a study. Like Investigator records, site records are not restricted to particular studies.

For more information, see:

• Creating Site Records
  
• Assigning Sites to a Study
  

Creating Site Records

You can create site records from the Maintain Study Sites window. A study site record is independent of study associations: you can assign a site to any studies. To create a site record, from the Design menu, select Investigators and Sites, and select Sites. You can change site records until you designate a site record as active.

The Site Code value can be up to ten characters, and must be unique within a domain. The system determines the owning location. The Name field can be up to 60 characters in length. Select the Active box when you are ready to make the site record available for assignment to studies.

Assigning Sites to a Study

You can assign sites to a study from the Maintain Study Sites window. From the Design menu, select Investigators and Sites, then choose Study Sites. In this window you can describe in detail how to employ the site in your study. This window is also the starting point for assigning Investigators and patient positions to a study.

Note:

If you are using the Oracle Clinical - Siebel Clinical integration for your study you do not need to define study sites. The definition is populated automatically from Siebel Clinical.

If you have already selected a study during a session, the system takes it by default. If you intend to work on another study, be sure to change studies first. If you have not selected a study during this session, the system first presents a Select a Study dialog box. The system then displays all of the site records currently assigned to the selected study.

To add a site assignment to a study, use the list function to select another site in a new record row. The system populates most of the fields. Leave the Study Site field blank to force the system to generate the code value for you.

As a convenience, the Study Sites window has buttons that take you to related windows in the system. These extra buttons are:

• Site Details Displays the address and owning database. (Defined in the Maintain Sites window. See Creating Site Records for details.)

• Assignments Clicking this button takes you directly to the Maintain Investigators window, where you can assign Investigators to a site by selecting from a list of active Investigators. (See Assigning Investigators to Study Sites for more information about this window.)

• Patients You can link a study's patient positions to a site. Select the Assign? box for each existing patient position to assign to the selected study site code. The system populates all other fields.

• New Patients Assign patient positions codes to a site by range. Enter the number of patients and the start number. Then click the Assign Patients button to assign them to the study site.