Completing Clinical Trip Reports

After the site visit, you record the trip report details, such as:

• The planned activities that you complete

• Additional activities that you complete

• Site personnel that you meet

• Any follow-up items that arise from the trip

• Comments on any of the previous items

Anyone can update and edit the records in the Trip Report Detail view at any time. For this reason, the end user can create a static report at the completion of the site visit, using the Siebel Report Viewer. This read-only document is ideal for archiving: as a printed document, as a file, or as an attachment to the site record in the Siebel Life Sciences database.

To complete a clinical trip report 

1. Navigate to the Site Visits screen, then the Clinical Site Visits List view.

2. In the Clinical Site Visits list, drill down on the Visit Start field of the site visit for which you want to complete a trip report.

   The Trip Report form for the selected site visit appears.

3. Complete or edit fields in the Trip Report form.

   Some fields are described in the following table.

   Field	Comments
   Completed	Select the date and time that you complete the site visit. This field is populated with the system date and time when you update the Visit Status field to Done. The filter in the All Follow-Up Items list uses this date to determine the closed follow-up items to show.
   Visit Status	Select the status of the site visit, for example, Planned or Completed.
   Reviewer Comments	Displays the reviewer comments if a reviewer submits a trip report with status Rejected.
   Approver Comments	Displays the approver comments if an approver submits a trip report with status Rejected.
   Visit Type	Select the nature of the visit, for example, Pre-Study, Site Initiation, or Site Monitoring.
   Attendees	Select the contacts (site personnel) that you meet during the visit.
   Reviewer	Select the user who reviews the trip report. An automated email notification is sent to the reviewer when you update the status of the trip report to Submitted.
   Approver	Select the user who approves the trip report. An automated email notification is sent to the approver when the reviewer updates the status of the trip report to Submitted for Approval.
   Assigned To	Select the users assigned to the trip report. The team member who creates the trip report is the primary owner.
   Trip Report Completed	Select the date that the trip report is complete and ready for submission. This field is populated with the system date when you update the Visit Status field of the trip report to Completed.

   
   

4. Navigate to the Checklist Activities view, complete the Status and Comments fields for planned activities, and add any unplanned activities that you completed.

5. Navigate to the Follow-Up Items view, and complete the following steps:

   1. Add any follow-up activities resulting from the site visit.

   2. In the Current Trip Follow-Up Items list, click Menu (the cogwheel icon), and choose Select All to display all open follow-up items and those items closed between the current and previous trip.

   3. Update the records for those follow-up items that you addressed during the site visit.

      Some fields are described in the following table.

      Field	Comments
      Status	Displays a value of Done when you select a completed date for the item.
      Completed Date	Select the resolution date and time of the follow-up issue. You must populate this field because the filter in the All Follow-Up Items list uses this date to determine the closed follow-up items to show.

      
      

6. Set the Trip Report Status field to Submitted.

   The report is submitted to the reviewer for review.