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. Consequently, the study manager can keep track of all site visits for all CRAs. The calendar entry is a useful reminder for investigators of scheduled site visits.

You create site visits using the Protocol Site List view of the Site Management screen. From this view, CRAs can view all their site visits and all follow-up activities that arise from their visits. You can also view all site visits and follow-up activities associated with visits. Study managers can filter site visits to see the visits that are assigned to their teams, and view follow-up activities to assess the most pressing issues.

Site visits are sorted by default according to the Visit Start date, so that the most recent site visit appears first in the site visits list.

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.

   Site visits in this view are sorted according to the Visit Start date. The most recent site visit, with the most recent Visit Start date, appears first in the site visits list.

4. Create a new record and complete the necessary fields as shown in the following table.

   Field	Comments
   Visit Name	Type a descriptive name for the visit (this is the default behavior). A warning pop-up message appears if you try to create a site visit with a name that already exists, provided the Duplicate Visit Name Alert user property is set to Y in Siebel Tools (the default value for this user property is N). You can either change the site visit name or continue with the duplicate site visit name. This field with be automatically populated if you have enabled the site visit name to be automatically generated. For more information, see About Site Visit Name.
   Visit Start	Select the date and time that the visit is due to occur. When you drill down on this field, you see the trip report for the visit.
   Visit Status	Select the status of the site visit.
   Trip Report Completed	Select the date that the trip report for this visit is complete.
   Trip Report Status	Select the status of the trip report. The following values are available: Not Started In Progress Completed Submitted Approved Rejected A preconfigured state model allows for a structured state transition. For more information about trip reports, see Administering and Using Clinical Trip Reports
   Assigned To	Select the user ID of the person assigned to the site visit.