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

Creating and Managing Clinical Trial Site Visits

CRAs typically need to carry out five types of visits to a site as follows:

• 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 case report forms (CRFs)
• 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 need to 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 Site Management screen, then the Protocol Site List view. 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 in the system and follow-up activities associated with these visits. Study managers can also filter site visits to see what visits are assigned to their teams and view follow-up activities in order to assess what the most pressing issues are.

To create a clinical trial site visit

1. Navigate to the Site Management screen, then the Protocol Site List view.
2. In the Sites list, drill down on the Site # for the site with which you want to create a visit and click the Site Visits tab.

   Some fields are described in the following table.

   Field	Comments
   Assigned To	User ID for the person to whom the clinical trial site visit is assigned.
   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 status options include the following: Not Started In Progress Completed Submitted Approved Rejected A state model is preconfigured to allow for structured state transition.For more information on 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 clinical trial site visit.

Monitoring Site Visits Using the Calendar

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