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Selecting a Clinical Trip Report Template


Although a trip report is designed to be written after a site monitoring visit, it can be used during a site monitoring visit to guide the CRA through a list of required activities.

The Trip Reports view contains the following lists:

  • Checklist Activities. Activities in this list can be generated by applying a trip report template. Ad-hoc activities can also be created individually.
  • Follow-up Items. These are the activities that need to be followed up later. The Current Trip and Follow Up-Items view allows the CRA to record, and later to review, the follow-up items associated with the current site visit. The All Follow-Up Items view (accessed using the filter) lists follow-up items from both previous visits and also from the current visit.
  • Case Report Forms Tracking. The items in this list track the Case Report Forms corresponding to subject visits.

To select a clinical trip report template

  1. Navigate to the Site Visits screen.
  2. In the Site Visits list, click the hyperlink in the Visit Start field of the visit for which you want to create the trip report.

    The Trip Report view is displayed. Some of the fields will already be populated from when the site visit was created.

  3. In the Template field, select the name of the trip report template that you want to apply.

    When you click off the Template field, the activities defined in the template appear in the Checklist Activities list.

  4. (Optional) Edit the activities in the Checklist Activities list or create more activities.

    Some fields are described in the following table.

    Field
    Comments

    Display In

    Indicates where the activity should be displayed.

  5. If there are follow-up items from previous trips, review them:
    1. In the Clinical Site Visits List view, from the drop-down menu, select All Follow Up Activities.

      This displays all follow-up issues for that site (open and closed; past, present, and future).

    2. Click Filter.

      This displays all the open-to-date follow-up items and any follow-up items that were closed between completed dates of the last trip and the current trip.

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