Siebel Clinical Trial Management System Guide > Administering and Using Clinical Trip Reports >

Completing Clinical Trip Reports


After the site visit, the trip report details are recorded, such as:

  • The planned activities that were completed
  • Additional activities that were carried out
  • Site personnel that they met
  • Any follow-up items arising from the trip
  • Comments on any of the above

The records in the Trip Report Detail view can be updated and edited at any time. For this reason, it is likely that the end user wants to 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

    Attendees

    The contacts (site personnel) whom you met during the visit.

    Approver

    The user assigned to approve the trip report. An automated email notification is sent to the approver when the status of the trip report is updated to Submitted for Approval.

    Approver Comments

    This field must be populated if an approver submits a trip report with status Rejected.

    Assigned To

    Multiple users can be assigned to the trip report. The team member who creates the trip report is indicated as the primary owner.

    Completed

    The date and time when the site visit was completed. This field is populated with the system date and time when the Visit Status field is updated to Done. The filter in the All Follow-Up Items list uses this date to determine which closed follow-up items to show.

    Reviewer

    The user assigned to review the trip report. An automated email notification is sent to the reviewer when the status of the trip report is updated to Submitted.

    Reviewer Comments

    This field must be populated if a reviewer submits a trip report with status Rejected.

    Site Visit Status

    The status of the site visit, for example, Planned or Completed.

    Trip Report Completed

    The date when the trip report is complete and ready for submission. This field is populated with the system date when the Status field of the trip report is updated to Completed.

    Visit Type

    The nature of the visit, for example, Pre-Study, Site Initiation, or Site Monitoring.

  4. Navigate to the Checklist Activities view, and complete the Status and Comments fields for planned activities and add any unplanned activities that you might have carried out.
  5. Navigate to the Follow-Up Items view, and add any follow-up activities resulting from the site visit.
  6. In the Current Trip Follow-Up Items list, click the cogwheel icon, and choose Select All to display all open follow-up items and those closed between the current and previous trip.
  7. Update the records for those follow-up items that were addressed during the site visit.

    Some fields are described in the following table.

    Field
    Comments

    Completed Date

    The resolution date of the follow-up issue. This field must be populated because the filter in the All Follow-Up Items list uses this date to determine the closed follow-up items to show.

    Status

    This field automatically changes to Done when a completed date is entered for the item.

  8. Set the Trip Report Status field to Submitted.

    The report is submitted to the reviewer for review.

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