Siebel Clinical Trial Management System Guide > Managing Sites and Contacts for Clinical Trials >

Creating and Managing Site Visits

CRAs (clinical research associates) typically carry out the following types of visits to a site:

• Site evaluation. A site visit to evaluate a site's qualification for a study
• Site initiation. A site visit to initiate a site
• Site monitoring. A site visit to monitor study progress and to monitor and retrieve CRFs (case report forms)
• Site close-out. A site visit to close out or terminate a site at the conclusion of a study
• Unscheduled. (Optional) An unexpected site visit that a CRA can carry out

CRAs create these visits for each site for which they are responsible. When a CRA creates a site visit, it appears in the CRA's calendar, the site investigator's calendar, and the study manager's calendar. This means that the study manager can keep track of all site visits for all CRAs. It also acts as a useful reminder for investigators of when site visits are to be made.

Site visits are created using the Protocol Site List view of the Site Management screen. From this view, it is possible for CRAs to view all their site visits and all follow-up activities that arise from the visits. It is also possible to view all site visits and follow-up activities associated with these visits. Study managers can also filter site visits to see the visits that are assigned to their teams and view follow-up activities in order to assess the most pressing issues.

This task is a step in Process of Managing Sites and Contacts for Clinical Trials.

To create a site visit

1. Navigate to the Site Management screen, then the Protocol Site List view.
2. In the Protocol Site list, drill down on the site number field for the site with which you want to create a visit.
3. Navigate to the Site Visits view.
4. Create a new record and complete the necessary fields.

   Some fields are described in the following table.

   Field	Comments
   Assigned To	User ID for the person assigned to the site visit.
   Trip Report Completed	The date on which the trip report for this visit has been completed.
   Trip Report Status	The status of the trip report. The following values are available: Not Started In Progress Completed Submitted Approved Rejected A state model is preconfigured to allow for structured state transition. For more information about trip reports, see Administering and Using Clinical Trip Reports.
   Visit Name	A descriptive name for the visit.
   Visit Start	The date on which the visit is due to take place. When you drill down on this field, you are brought to the trip report for the visit.
   Visit Status	The status of the site visit.

Monitoring Site Visits Using the Calendar

All CRA (clinical research associate) visits to a site can also be monitored from the Calendar view. The calendar can be used to view visits on a daily, weekly, or monthly basis.