Siebel Life Sciences Guide > Administering and Using Clinical Trip Reports >

Completing a Trip Report After a Site Visit (End User)


After the site visit, the end users record details of their trips, such as:

  • Which of the planned activities were completed
  • What additional activities were carried out
  • Which site personnel they met
  • Any follow-up items arising from the trip
  • Comments to 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 will want to create a static report at the completion of the trip, 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 trip report

  1. Navigate to the Trip Report view and select the trip report that you want to complete.

    For details on how to do this, see Step 1.

  2. Complete or edit fields in the Trip Report form. See also Step 3.

    Some fields are described in the following table.

    Field
    Comments

    Attendees

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

    Completed

    The date and time on which the trip report is completed. It is important that this date be filled in because the filter in the All Follow-Up Items list uses this date to determine which closed follow-up items to display (Step 6). This field becomes required when the Visit Status is changed to Done.

    Trip Report Status

    The status of the trip report.

  3. In the CheckList list, complete the Status and Comments fields for planned activities and add any unplanned activities that you may have carried out.
  4. In the Current Trip Follow-Up Items list, add any follow-up activities resulting from the site visit.
  5. In the Current Trip Follow-Up Items list, from the drop-down menu, select All Follow-Up Items and click Filter to display all open follow-up items and those closed between the current and previous trip.
  6. 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. It is important that this date be filled in. The filter in the All Follow-Up Items list uses this date to determine which closed follow-up items to display (Step 6).

    Status

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

  7. When all the above tasks have been completed and the trip report is ready to be submitted for review, you should change the value of the Trip Report Status to Submitted. This submits the report to the study manager for approval.

To create a case report form tracking activity

NOTE:  The Case Report Forms Tracking view is only available for site visits of type Monitoring, Unscheduled, or Close-out.

  1. Navigate to the Trip Report view.
  2. In the Case Report Forms Tracking view, create a new record.
  3. Click the select button in the Visit field, select a subject and visit in the Pick Subject and Visits dialog box, and complete the necessary fields.

    Some fields are described in the following table.

    Field
    Comments

    Retrieved

    This field is checked when the CRA retrieves the case report forms from the site.

    Source Document Verified

    This field is checked when the case report form has been verified from the source document.

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