Siebel Life Sciences Guide > Managing Sites and Clinical Contacts >

Creating and Managing 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 may wish to 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 > 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.

Depending on the type of site visit you choose, the drill down views vary. If the site visit type is Site Initiation or Site Evaluation, then the drill down view does not contain the CRF Tracking tab. If the site visit type is Site Monitoring or Site close-out, the drill down view contains the CRF Tracking tab. For more information, see Defining a Subject Visit Template.

To create a site visit

1. Navigate to the Site Management screen > 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
   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. 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	Not Stated, In Progress, Completed, Submitted, Approved, and Rejected. A state model is preconfigured to allow for structured state transition.

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.