Administering and Using Clinical Trip Reports

This chapter describes how to set up and use clinical trip reports in Siebel Clinical. It includes the following topics:

About Administering and Using Clinical Trip Reports

The study managers or clinical administrators can set up templates for trip reports. The CRAs (clinical research associates) then use these templates when they create trip reports to record their visits to sites.

Advantages of using the trip reports in Siebel Clinical are:

Trip reports are consistent across the organization and are based on GCP (good clinical practice) and SOPs (standard operating procedures).
CRAs save time planning trips and writing trip reports.
Managers save time reviewing trip reports.
End users can generate a formatted, tamper-proof report for print or PDF from the trip report record.
A central repository exists for all trip reports.

Scenario for Managing Clinical Trip Reports

This topic gives one example of how to manage clinical trip reports. You might manage clinical trip reports differently, depending on your business model.

This topic includes the following information:

Preparing Trip Report Templates

A clinical administrator prepares a set of trip report templates for the CRAs (clinical research associates) to use when preparing for and writing up their visits to clinical sites. For more information about site visits, see Creating and Managing Site Visits.

The clinical administrator prepares the following templates for each type of site visit the CRAs typically must perform:

Site evaluation
Site initiation
Site monitoring
Site close-out

Preparing Trip Reports

The CRA (clinical research associate) is the end user of the Siebel Clinical product. Before visiting a site, the CRA uses the trip report to prepare for the visit. The follow-up items list reminds the CRA of the open activities from previous visits that the CRA can close.

After preparing a draft trip report, the CRA makes a hard copy of the report and takes this copy on the site visit. He can use the report as a reference to help keep track of the activities he completes while at the site.

After returning from a site visit, the CRA completes the trip report and generates a final report. He then submits this report to the study manager for approval. The manager reviews the report and approves it if it is satisfactory. If the manager approves the trip report, then it is then locked to prevent the CRA from making any further changes. If the trip report is not satisfactory, then the manager can reject the report and return it to the CRA for further attention.

Creating Questions for Clinical Trip Reports Using Siebel Smart Script

You can use Siebel SmartScript to create questionnaires for clinical trip reports. For information about how to create questions using Siebel SmartScript, see Siebel SmartScript Administration Guide.

Some SmartScript question settings listed in Siebel SmartScript Administration Guide are not applicable for clinical trip reports. The following information lists the question settings that are not applicable to clinical trip reports.

Table Exceptions for Smart Script Question Settings

Question Setting	Questionnaire Exception for Clinical Trip Reports
Answer Type	The Currency data type is not supported.
Auto Sub Parm	This setting is not applicable.
Search Spec	This setting is not applicable.
Save Business Object	This setting is not applicable because the answers to questionnaires for clinical trip reports are automatically saved as part of the clinical trip reports.
Save Bus Comp	This setting is not applicable because the answers to questionnaires for clinical trip reports are automatically saved as part of the clinical trip reports.
Save Field	This setting is not applicable because the answers to questionnaires for clinical trip reports are automatically saved as part of the clinical trip reports.
Save User Parameters	This setting is not applicable.
Save Currency Field	This setting is not applicable because the answers to questionnaires for clinical trip reports are automatically saved as part of the clinical trip reports.
Pick Applet	This setting is not supported.
Mvg Applet	This setting is not supported.
Detail Applet	This setting is not supported.
Save Answer Table	This setting is not applicable because the answers to questionnaires for clinical trip reports are automatically saved as part of the clinical trip reports.
Currency	This setting is not applicable.

You can assign a SmartScript questionnaire to a clinical trip report template after it is released using Siebel SmartScript. For information about how to release a script using Siebel SmartScript, see Siebel SmartScript Administration Guide.

Creating Clinical Trip Report Templates

Typically, the clinical administrator prepares a number of generic trip report templates, perhaps one designed for each of the different stages in the study. This topic describes how to create a clinical trip report. You can define additional activities, such as follow-up tasks to complete after the visit to the clinical site, in the Trip Report Template Details view.

To create a clinical trip report template

Navigate to the Administration - Clinical screen, then the Trip Report Templates view.

Create a new record and complete the necessary fields.

Some fields are described in the following table.

Field	Comments
Name	Type the name of the clinical trip report template.
Visit Type	Select the type of site visit, for example, Site Evaluation, Site Initiation, or Site Monitoring.
Protocol #	Select the protocol for the clinical site.
Region	Select the region for the clinical site.
SmartScript	Select a SmartScript questionnaire for the trip report template. The questionnaire is copied to the Questions view of the trip report when you apply the trip report template to the trip report. The questionnaire uses branching logic to dynamically determine the flow of questions by using answers to prior questions. The Siebel Clinical Trial Management System administrator determines the question hierarchy by using Siebel SmartScript. For more information about Siebel SmartScript, see Siebel SmartScript Administration Guide.

Drill down on the Name field of the trip report template to display the Trip Report Template Details view.

Create new records for any trip report activities to define.

Some fields are described in the following table.

Field	Comments
Activity	Select the type of trip report activity. The following values are available: Checklist Follow-Up Issues
Priority	Select the priority of the trip report activity.

Field

Comments

Activity

Select the type of trip report activity. The following values are available:

Checklist
Follow-Up
Issues

Priority

Select the priority of the trip report activity.

Applying Clinical Trip Report Templates

The Template field of the Site Visits view displays all of the trip report templates that are applicable to protocol, region, and visit type details for that site visit. When you apply a trip report template to a trip report, all of the details in the template are copied to the trip report.

Checklist and follow-up activities in the Trip Report Template Details view of the trip report template are copied to the trip report, and overwrite any existing checklist and follow-up activities in the trip report.

SmartScript questionnaires in the SmartScript field of the trip report template are applied to the trip report, and appear in the Questions view. For performance reasons, the SmartScript questionnaire does not appear in the Questions view until after the user launches the SmartScript questionnaire. For more information about SmartScript questionnaires, see Completing Questionnaires for Clinical Trip Reports.

To apply a clinical trip report template

Navigate to the Site Visits screen, then the Clinical Site Visits List view.
In the Clinical Site Visits list, drill down on the Visit Start field of the site visit to which you want to apply a trip report template.
The Trip Report form for the selected site visit appears.
Click the select button in the Template field.
A list of templates that correspond to the protocol, region, and visit type details for the site appears.
Select the name of the trip report template that you want to apply, and click OK.
When you save the Template field, the activities in the template appear in the Checklist Activities list and Follow-Up Items list.

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

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

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.

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

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

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

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.

Set the Trip Report Status field to Submitted.
The report is submitted to the reviewer for review.

Completing Questionnaires for Clinical Trip Reports

This topic describes how to complete a questionnaire for a clinical trip report. You launch the questionnaire in the SmartScript player from the Questions view of the trip report. Questions and responses are saved in the Questions list.

To complete a questionnaire for a clinical trip report

Navigate to the Site Visits screen, then the Clinical Site Visits List view.
In the Clinical Site Visits list, drill down on the Visit Start field of the site visit for the required trip report.
The Trip Report form for the selected site visit appears.
Navigate to the Questions view.
Click Answer to launch the questionnaire for the trip report in the SmartScript player.
Complete the questionnaire, and click Finish or Finish Later.
The responses are saved with the questions in the Questions list. You can filter questions as follows:
- To display only answered questions, select Show Answered.
- To display all questions in the questionnaire for the trip report, select Show All.

Deleting Unanswered Questions from Questionnaires of Clinical Trip Reports

This topic describes how to delete unanswered questions from a questionnaire for a clinical trip report, using the LS Clinical Questions Batch Clean-up repository workflow process.

Note: This task requires administrator privileges.

To delete unanswered questions from a questionnaire of a clinical trip report

Navigate to the Administration - Server Management screen, then the Jobs view.
Create a new record and complete the necessary fields.
Set the Component/Job field to Workflow Process Manager.
In the Job Parameters list, create a new record and complete the necessary fields.
Set the Name field to Workflow Process Name and the Value field to LS Clinical Questions Batch Clean-up.
Select the record in the Jobs list, and click Submit Job.
Refresh the screen and verify that the State field updates to Success.
All unanswered questions in the questionnaire for the clinical trip report are now deleted.

Tracking Case Report Forms

This topic describes how to create a CRF (case report form) tracking activity. You capture relevant information, such as review date and page numbers verified, for each CRF record.

To track case report forms

Navigate to the Site Visits screen, then the Clinical Site Visits List view.
In the Clinical Site Visits list, drill down on the Visit Start field of the site visit for which you want to track case report forms.
Navigate to the Case Report Forms Tracking view.
To add case report forms for scheduled subject visits, complete the following steps:
1. Click Add Scheduled.
2. Select the subject visits in the dialog box that appears.
3. Click OK.
The case report forms for selected subject visits appear in the Case Report Forms Tracking view.
To add case report forms for unscheduled subject visits, complete the following steps:
1. Click Add Unscheduled.
2. Select the subject visits in the dialog box that appears.
3. Click OK.
The case report forms for selected subject visits appear in the Case Report Forms Tracking view.

Complete the necessary fields in the case report forms.

Some fields are described in the following table.

Field	Comments
Source Verified	Select this field when you verify the CRF against the source document.
Retrieved	Select this field when you retrieve the CRFs from the site.
Page Numbers Verified	Type the CRF page numbers that you verify.
Charts Reviewed Date	Select the date and time that you review the clinical charts.
Forms Signed Date	Select the date and time that you sign the CRFs.

Automated Validation and Notification Messages for Clinical Trip Reports

The state model for the trip report provides the order of transition for values in the Trip Report Status field to indicate the progress of the trip report. The following table describes the values for the Trip Report Status field, the update type (such as automatic or user), the trip report validation, and the automated notification emails sent to the assignee’s Universal Inbox for each status, where applicable.

Note: The Notifications feature is enabled by default for all Siebel Business Applications so all notification messages for clinical trip reports are sent directly to the screens of users. Messages appear in notification panes that users access by clicking Notification on the application banner. For more information about using, administering and reviewing notifications, see Siebel Fundamentals Guide.

Table Values in Trip Report Status Field, Validation, and Messages

Value in Trip Report Status Field	Description	Update Type	Validation	Automated Email Notification
Not Started	The end user created the trip report, but processing is not yet started. This status is the initial default value for all trip reports.	System	Not applicable.	Not applicable.
In Progress	The end user started to work on the trip report, and it is not yet complete.	System if the trip report is created using a template. User if the trip report is not created using a template.	Not applicable.	Not applicable.
Completed	The end user completed the trip report, and it is ready for the end user to submit for review.	User	The trip report is validated to ensure that the Completed Date is populated. The Completed Date is a prerequisite for selecting Completed.	Not applicable.
Submitted	The end user submitted the trip report to the reviewer for review.	User	The trip report is validated to ensure that a reviewer is assigned.	The following automated email is sent to the reviewer: Review Trip Report [Trip Report Name]. If you change the reviewer when the Trip Report Status field is Submitted, then this notification email is sent to the new reviewer.
Reviewed with Comments	The reviewer or approver added review comments requiring a modification to the trip report.	User	Not applicable.	The following automated email is sent to the trip report owner: Rectify Trip Report [Trip Report Name].
Rejected	The reviewer or approver rejected the trip report.	User	The trip report is validated to ensure that one of the following fields is completed: Reviewer Comments Approver Comments	The following automated message is sent to the trip report owner: Rectify Trip Report [Trip Report Name].
Revised	The end user modified the rejected trip report, and it is not yet resubmitted for review.	User	Not applicable.	Not applicable.
Submitted for Approval	The reviewer submitted the trip report for formal review, without comments or with comments that do not require a change to the trip report.	User	The trip report is validated to ensure that an approver is assigned.	The following automated email is sent to the approver: Approve Trip Report [Trip Report Name]. If the you change the approver when the Trip Report Status field is Submitted for Approval, then this notification email is sent to the new approver.
Approved	The approver approved the trip report, and it is now read-only. When the approver clicks the Approved button, the Trip Report Status field is updated to Approved.	System	Not applicable.	Not applicable.

Tracking Completion Status for Clinical Trip Reports

This task describes how to track the real-time progress for a trip report in the Summary view. You track the status for the following fields in the clinical trip report:

Checklists Completed
Questions Answered
Current Follow-Ups Completed
All Follow-Ups Completed
CRF Tracking Completed
Total Attendees

To track the completion status for a clinical trip report

Navigate to the Site Visits screen, then the Clinical Site Visits List view.
In the Clinical Site Visits list, drill down on the Visit Start field of the site visit for which you want to track the status of the trip report.
The Trip Report form for the selected site visit appears.

Navigate to the Summary view.

The summary status appears in the Summary applet.

Some fields are described in the following table.

Field	Comments
Checklists Completed	Displays the number of completed checklists and the total number of checklists. The drill-down navigates to the Checklist Activities view. All checklists in the Checklist Activities view that have a Status of Done or Completed are listed as completed in the Summary view.
Questions Answered	Displays the number of answered questions, the total number of SmartScript questions for the trip report, and the SmartScript questionnaire status. The value ranges are as follows: 0 of 0, Not Assigned. The user has not assigned a SmartScript questionnaire to the trip report. [Total Answered] of [Total Questions], In Progress. The user launched the SmartScript questionnaire, and it is in progress. [Total Answered] of [Total Questions], Finished. The user completed answering all of the questions. The drill-down navigates to the Questions view.
Current Follow-Ups Completed	Displays the number of completed follow-up activities and the total number of follow-up activities for the current trip report. The drill-down navigates to the Current Trip Follow-Up Items view. All follow-ups in the Current Trip Follow-Up Items view with a value in the Completed Date field are listed as completed in the Summary view.
All Follow-Ups Completed	Displays the number of completed follow-up activities and the total number of follow-up activities for all trip reports applicable to the clinical site. The drill-down navigates to the All Follow-Up Items view. All follow-ups in the All Follow-Up Items view with a value in the Completed Date field are listed as completed in the Summary view.
CRF Tracking Completed	Displays the number of completed CRF (case report form) tracking activities and the total number of CRF tracking activities. The drill-down navigates to the CRF Tracking view. All CRF tracking activities in the CRF Tracking view that have a status of Source Verified are listed as completed in the Summary view.
Total Attendees	Displays the total number of attendees assigned to the trip report.

Tracking Status Accruals for Clinical Subjects of Sites

This task describes how to track the progress of subject status accruals for a clinical site by creating a real-time snapshot of the current subject status accruals for the site. The CRA (clinical research associate) can use the snapshot to verify the subject status data that an end user manually records during a site visit.

To track status accruals for clinical subjects of a site

Navigate to the Site Visits screen, then the Clinical Site Visits List view.
In the Clinical Site Visits list, drill down on the Visit Start field of the site visit for which you want to track the status accruals for subjects.
The Trip Report form for the selected site visit appears.
Navigate to the Summary view.

Click Capture in the Subject Status Snapshot applet to generate a real-time snapshot of subject status accruals.

Some fields are described in the following table.

Field	Comments
Visit Type	Displays the type of clinical visit. The following clinical visit types are preconfigured: Screening Rescreening Enrollment End of Study
Subject Status	Displays the subject status. The following subject visit statuses are preconfigured: Screened Screen Failure Randomized Enrolled Completed Early Terminated Re-screened Withdrawn
Total Accrual Number	Displays the number of current and past subject status accruals that are automatically created for the site visit.
Total Actual Number	Type the number of current and past subject status accruals that you manually recorded during the site visit.
Current Accrual Number	Displays the number of current subject status accruals that are automatically created for the site visit.
Current Actual Number	Type the number of current subject status accruals the you manually recorded during the site visit.
Comments	Type a description of any discrepancy between accrual numbers and actual numbers.
Reviewer Comments	Type reviewer comments about the trip report. Only the assigned reviewer can modify this field.
Time Stamp	Displays the date and time that the snapshot is generated.

Viewing Universal Inbox Notifications for Action Items of Clinical Trip Reports

The Inbox provides a centralized list of items requiring your attention, such as clinical trip reports requiring review, revision, and approval. The following procedure shows you how to access and view Universal Inbox notifications for action items of clinical trip reports. Alternatively, you can click Notification on the application banner to access and view all notification messages, including those for clinical trip reports.

Note: The Notifications feature is enabled by default for all Siebel Business Applications so all notification messages for clinical trip reports are sent directly to the screens of users. Messages appear in notification panes that users access by clicking Notification on the application banner. For more information about using, administering and reviewing notifications, see Siebel Fundamentals Guide.

To view Universal Inbox notifications for action items of a clinical trip report

From the application-level menu, choose Navigate, then Site Map.
Click Inbox.
The views available for the inbox appear.
Click Inbox Items List.
The list of notifications for your trip reports appears. The action required for each trip report appears in the Name field.
Drill down on the Name field to view each trip report requiring action.

Reviewing Clinical Trip Reports

The user designated in the Reviewer field of the Trip Report form can review trip reports with a status of Submitted. An automated notification email is sent to the reviewer when an end user updates the trip report status to Submitted.

Access control applies to the Reviewer Comments field. Only the user designated in the Reviewer field of the Trip Report form can edit the Reviewer Comments field.

To review a clinical trip report

Navigate to the Site Visits screen, then the Clinical Site Visits List view.
In the Clinical Site Visits list, select My Team’s Site Visits in the visibility filter.
All site visits for your team appear.
Query the list for site visits with a Visit Status field value of Submitted or Submitted for Approval.
For the required report, drill down on the Visit Start field.
The Trip Report form appears.
Review the report.
Set the Trip Report Status field to one of the following values:
- Reviewed with Comments. Use this value if minor changes to the trip report are required. Enter the required corrections in the Reviewer Comments field.
- Rejected. Use this value if major changes to the trip report are required. Enter the required corrections in the Reviewer Comments field.
- Submitted for Approval. Use this value if the trip report does not require additional changes, and is ready for approver review.
- Obsolete. Use this value to retire the current or active version of a trip report. This makes it possible to reopen and create a new version of the trip report.
The date and time of the review of the clinical trip report are recorded in the Reviewed Date field.

Approving Clinical Trip Reports

The assigned approver can approve trip reports with a status of Submitted for Approval. Only the user designated in the Approver field of the trip report has approval permission. An automated notification email is sent to the approver when an end user updates the trip report status to Submitted for Approval. If the approver sets the Trip Report Status field to Rejected, then the CRA (clinical research associate) has the opportunity to revise the report and then resubmit it for approval.

Note: The User Authentication applet for approver verification of a trip report is not enabled by default. To enable this functionality, your system administrator must set the Enable Verification option to Y in the Named Method 2 user property in Siebel Tools. For more information about this user property, see User Properties for Business Components in Siebel Clinical.

Access control applies to the Approver Comments field. Only the user designated in the Approver field of the Trip Report form can edit the Approver Comments field.

To approve a clinical trip report

Navigate to the Site Visits screen, then the Clinical Site Visits List view.
In the Clinical Site Visits list, select My Team’s Site Visits in the visibility filter.
All site visits for your team appear.
Query the list for site visits with a Visit Status field value of Submitted or Submitted for Approval.
For the required report, drill down on the Visit Start field.
The Trip Report form appears.
Review the report.
(Optional) Add approval comments in the Approver Comments field.
Click Approve.
The User Authentication view appears.
Enter user credentials, and click Verify.
The Trip Report Status field is updated to Approved, the approval date and time are recorded in the Approved Date field, and the site visit record and trip report become read-only.

Making Clinical Trip Reports Obsolete

Active trip reports can be made obsolete at any time.

To make a clinical trip report obsolete

Navigate to the Site Visits screen, then the Clinical Site Visits List view.
In the Clinical Site Visits list, select My Team’s Site Visits in the visibility filter.
All site visits for your team appear.
In the Clinical Site Visits list, drill down on the Visit Start field of the site visit that you want to make obsolete.
The Trip Report form appears.
Set the value in the Trip Report Status field to Obsolete.
The current version of the trip report is retired and the Version button on the trip report is activated. This makes it possible to reopen and create a new version of the trip report.

Creating New Versions of Clinical Trip Reports

After a trip report is approved or made obsolete, it is locked (becomes read-only) and the Version button on the trip report is activated. This allows you to reopen and create a new version of the trip report. You can modify and route the new version of the trip through the approvals process again.

You cannot create new versions of trip reports that are active. A message similar to the following appears if you try to create a new version from an active trip report:

Another version of this trip report exists. Use the other trip report version, or change the status of that version to Obsolete and create a new version.

To create a new version of a clinical trip report

Navigate to the Site Visits screen, then the Clinical Site Visits List view.
In the Clinical Site Visits list, select My Team’s Site Visits in the visibility filter.
All site visits for your team appear.
Query the list for site visits with a Visit Status field value of Approved or Obsolete.
For the required report, drill down on the Visit Start field.
The Trip Report form appears.
Review the report.
(Optional) Add reviewer comments in the Reviewer Comments field.
Click Version.
A new version of the trip report is created where all data from the original trip report is copied over to the newly created trip report. Note the following:
- The value in the Version field for the new trip report changes by incrementing by one.
- The value in the Trip Report Status field for the new trip report changes to In Progress.
- The value in the Trip Report Status field for the original trip report (for approved trip reports only) changes from Approved to Obsolete.
Modify and approve the trip report as required.
For mor e information, see Completing Clinical Trip Reports and Approving Clinical Trip Reports.

Viewing Version Information for Clinical Trip Reports

The Versions view shows all the prior trip report versions for a selected trip report.

To view version information for clinical trip reports

Navigate to the Site Visits screen, then the Clinical Site Visits List view.
In the Clinical Site Visits list, drill down on the Visit Start field of the site visit for which you want to view trip report versions.
The Trip Report form appears.

Navigate to the Versions view.

Some fields are described in the following table.

Field	Comments
Version	The version number of the trip report.
Visit Start	The visit start date and time.
Trip Report Status	The status of the trip report, which can be Approved or Obsolete.

Viewing Geographical Location Details for Clinical Trip Reports

A third-party application records dates, times, and geographical location details for sites in the trip report for each site monitor visit to each clinical site.

Multiple site monitors can create multiple site visit records in the trip report for the same site visit. Each site monitor can create multiple site visit records in the trip report for different times on the same site visit.

To view geographical location details for a clinical trip report

Navigate to the Site Visits screen, then the Clinical Site Visits List view.
In the Clinical Site Visits list, drill down on the Visit Start field of the site visit for which you want to view geographical location details.
The Trip Report form for the selected site visit appears.

Navigate to the Geo Location Details view.

Some fields are described in the following table.

Field	Comments
User Id	Displays the user ID of the site monitor who logs the geographical location details in the third-party clinical application.
Latitude	Displays the latitude coordinate of the site. Latitude coordinates are represented in decimal degree format. The range of acceptable values is 0 to plus or minus 90. Northern hemisphere latitudes are represented by a positive number. The number is preceded by a minus sign to represent southern hemisphere latitudes.
Longitude	Displays the longitude coordinate of the site. Longitude coordinates are represented in decimal degree format. The range of acceptable values is 0 to plus or minus 180. Eastern hemisphere latitudes are represented by a positive number. The number is preceded by a minus sign to represent western hemisphere longitudes.
Date	Displays the date and time the site monitor logs the geographical location details in the third-party clinical application.
Comments	Type any comments relating to the site visit. The site monitor populates this field.

Using Audit Trail for Reviews and Approvals of Clinical Trip Reports

The Approvals view provides a summary audit trail of the changes to the trip report status, including the dates and times of review and approval operations, and the details applicable to the users who complete those operations.

To use audit trail for reviews and approvals of a clinical trip report

Navigate to the Site Visits screen, then the Clinical Site Visits List view.
In the Clinical Site Visits list, drill down on the Visit Start field of the site visit for the required trip report.
The Trip Report form for the selected site visit appears.

Navigate to the Approvals view.

The Approvals applet appears.

Some fields are described in the following table.

Field	Comments
Login	Displays the login credentials of the user who modified the field.
Status	Displays the value in the Trip Report Status field after the change occurred.
Old Status	Displays the value in the Trip Report Status field before the change occurred.
Updated	Displays the date and time that the field was modified.

Using Audit Trail for Changes to Clinical Trip Reports

The Audit Trail view provides a detailed history of the changes to trip report records. The audit trail records for the trip report show operations for the following fields:

Comments
Reviewer
Reviewer Comments
Approver
Approver Comments
Trip Report Status

To use audit trail for changes to a clinical trip report

Navigate to the Site Visits screen, then the Clinical Site Visits List view.
In the Clinical Site Visits list, drill down on the Visit Start field of the site visit for the required trip report.
The Trip Report form for the selected site visit appears.

Navigate to the Audit Trail view.

Some fields are described in the following table.

Field	Comments
Employee Login	Displays the username of the user who changed the record.
Business Component	Displays the business component for the record where the database change occurred.
Field	Displays the name of the field where the change occurred.
Operation	Displays the type of operation that was performed, for example, New Record, or Modify.
Old Value	Displays the value in the field before the database change occurred.
New Value	Displays the value in the field after the database change occurred.
Date	Displays the timestamp of the change.
Record ID	Displays the unique identifier of the record that was changed.
Base Table	Displays the name of the primary database table where the database change occurred.
Column	Displays the name of the column in which the change occurred.
Group ID	Displays the unique identifier of the group to which the user who changed the record belongs.
Table	Displays the name of table to which the selected field belongs in the Siebel database.
Row ID	Displays the unique identifier of the row in which the change occurred.

Generating Oracle BI Publisher Reports for Site Visits

You can integrate Siebel Clinical with Oracle Business Intelligence Publisher (BI Publisher) to generate reports. You can generate, view, and schedule preconfigured Oracle BI Publisher reports in Siebel Clinical. For more information about using Siebel Reports and integrating with Oracle BI Publisher, see Siebel Reports Guide.

The following preconfigured reports apply to site visits:

Clinical Trip Report With CRF
Clinical Trip Report Without CRF

To generate an Oracle BI Publisher report for a site visit

Navigate to the Site Visits screen, then the Clinical Site Visits List view.
In the Clinical Site Visits list, drill down on the Visit Start field of the site visit for which you want to generate an Oracle BI Publisher report.
On the application toolbar, click Reports.

In the Run Report pane, complete the appropriate fields.

Some fields are described in the following table.

Field	Comments
Report Name	Select the Clinical Trip Report With CRF report or the Clinical Trip Report Without CRF report.
Output Type	Select the output type for the report.

Click Submit.
The report runs.
Click My Reports to navigate to the Reports view of the BI Publisher Reports screen.
A record for the report appears in the Reports view. For information about viewing and printing the report, see Siebel Fundamentals Guide.