4 Trip Reports

This chapter describes how to work with trip reports. It contains the following topics:

• Section 4.1, "Introduction to Trip Reports"

• Section 4.2, "Trip Report Fields"

• Section 4.3, "Trip Report Status Icons"

• Section 4.4, "Creating a Trip Report"

• Section 4.5, "Adding Attendees to a Trip Report"

• Section 4.6, "Adding an Item to the Trip Report Check List"

• Section 4.7, "Modifying an Item in the Trip Report Check List"

• Section 4.8, "Creating Follow up Items in a Trip Report"

• Section 4.9, "Creating a Trip Report Summary"

• Section 4.10, "Saving Trip Report Data to Oracle Siebel Clinical Trial Management System"

• Section 4.11, "Submitting a Trip Report for Approval"

• Section 4.12, "Viewing an Approved Trip Report"

4.1 Introduction to Trip Reports

Mobile CRA will display trip reports that are on the device or in CTMS. If the trip report is not on the device, the system will automatically fetch it.

You can create a trip report visit by entering a site visit date and selecting a site visit template. You can perform the following activities in relation to trip reports:

• Access the trip reports already created in CTMS

• Create a trip report

• Add attendees to the trip report

• Complete trip report activities by changing status, adding comments, and filling out custom fields

• Depending on your implementation, add trip report activities to check list

• Alter user-created trip report activities

• Create trip report follow up items

• Review previous trips reports

• Review final trip report

• Submit trip report to work flow for approval

Prerequisites

To create a Trip Report on Mobile CRA, you must:

1. have access to the study and site in question.

2. create a site visit record when you schedule the site visit.

4.2 Trip Report Fields

Every organization has different views of how trip reports should be structured. Mobile CRA supports each of the above modules out of the box. Your organization's configuration may result in different elements.

The following is an example of a trip report:

Figure 4-1 Trip Report Example

Description of "Figure 4-1 Trip Report Example"

A trip report consists of the following four main areas:

• About - This section contains details of the trip report like individuals working on it, the protocol it is related to, different dates associated and so on.

• Attendees - This section lists all the people associated with a particular site.

• Checklist Items - This section displays the list of tasks to be accomplished for a visit.

• Follow Up Items - This section displays the subsequent tasks to be performed before a visit can be completed.

• Summary - This section displays comments, summary of the site visit, or additional comments that is applicable for the entire trip report

For more information on the various fields in each section, refer to the Oracle Siebel Clinical Trial Management System User's Guide.

4.3 Trip Report Status Icons

Following are the possible status icons for a trip report:

Figure 4-2 Trip Report Icons

Description of "Figure 4-2 Trip Report Icons"

• The green filled circle indicates the trip report is on the device.

• The green open circle indicates that the trip report is not on the mobile device.

• The red filled circle with an M indicates that the trip report has been modified and not saved to the device.

4.4 Creating a Trip Report

If the trip report has not been created for a site visit, the trip report creation screen is displayed. If the trip report is on the device, you can use it immediately, in on-line or disconnected mode.

Perform the following steps to create a trip report:

1. In the My Studies pane, tap a study to view all the sites under it.

2. Tap a site to view all its details.

3. Tap Trip Reports. The site visits displayed.

4. Tap a visit to view its details.

   Figure 4-3 Visit Task List

   
   Description of "Figure 4-3 Visit Task List"
   
   

5. Tap Create Trip Report. A list of trip report templates is displayed.

   Figure 4-4 Trip Report Templates

   
   Description of "Figure 4-4 Trip Report Templates"
   
   

6. Select a template and tap Create.

   Note:

   To exit the trip report creation process, tap Cancel on the top right.

7. A trip report is created and a confirmation screen is displayed.

   Figure 4-5 Confirmation Screen

   
   Description of "Figure 4-5 Confirmation Screen"
   
   

8. Click OK to view the trip report.

9. Edit the appropriate trip report fields and tap Save to CTMS.

   Figure 4-6 Saving the Trip Report

   
   Description of "Figure 4-6 Saving the Trip Report"
   
   

10. Tap Save. Your report will be saved to CTMS and the status will change to completed. The following confirmation will be displayed:

    Figure 4-7 Trip Report Saved to CTMS

    
    Description of "Figure 4-7 Trip Report Saved to CTMS"
    
    

4.5 Adding Attendees to a Trip Report

You can add attendees to the trip report by selecting a contact from your Mobile CRA contact list. Perform the following steps to add attendees to your trip report:

1. In the My Studies pane, select a study and study-site.

2. Tap Trip Reports.

3. Select a trip report.

   Figure 4-8 Trip Report

   
   Description of "Figure 4-8 Trip Report"
   
   

4. Open the attendee list for that trip report. Tap the following icon to add attendees.

   Figure 4-9 Add Icon

   
   Description of "Figure 4-9 Add Icon"
   
   

5. Your Mobile CRA contacts associated with the study-site will be displayed.

   Figure 4-10 Mobile CRA Contacts

   
   Description of "Figure 4-10 Mobile CRA Contacts"
   
   

6. Tap the contact you want to add to the attendee list.

   Figure 4-11 Select Contact

   
   Description of "Figure 4-11 Select Contact"
   
   

   Note:

   You can add multiple contacts by selecting them at once.

7. Tap Done on the top left. The contact will be added.

   Figure 4-12 Attendee Added to Trip Report

   
   Description of "Figure 4-12 Attendee Added to Trip Report"
   
   

4.6 Adding an Item to the Trip Report Check List

Perform the following steps to add an item to the trip report check list:

1. In the My Studies pane, select a study and study-site.

2. Tap Trip Reports.

3. Select a trip report.

   Figure 4-13 Trip Report

   
   Description of "Figure 4-13 Trip Report"
   
   

4. Tap the icon below to add a checklist item.

   Figure 4-14 Add Icon

   
   Description of "Figure 4-14 Add Icon"
   
   

   Figure 4-15 New Checklist Item

   
   Description of "Figure 4-15 New Checklist Item"
   
   

5. Edit the required fields.

6. Navigate back to the trip report. The checklist item will be added.

   Figure 4-16 Checklist Item Added

   
   Description of "Figure 4-16 Checklist Item Added"
   
   

4.7 Modifying an Item in the Trip Report Check List

Perform the following steps to add an item to the trip report check list:

Note:

You cannot modify an item that originated in CTMS. Doing so will display an error message.

1. In the My Studies pane, select a study and study-site.

2. Tap Trip Reports.

3. Select a trip report.

   Figure 4-17 Trip Report

   
   Description of "Figure 4-17 Trip Report"
   
   

4. Tap the checklist item you want to modify.

   Figure 4-18 Checklist Item

   
   Description of "Figure 4-18 Checklist Item"
   
   

5. You can modify the type, display location, comments and status. You can also add an assignee. Make the modifications you require.

   Note:

   You can also change the Status of the checklist item at the top level.

4.8 Creating Follow up Items in a Trip Report

You can edit a follow up item for completeness until it is submitted. You can add a due date to the item and add it to the Task Calendar. Perform the following steps to add an item to the trip report check list:

1. In the My Studies pane, select a study and study-site.

2. Tap Trip Reports.

3. Select a trip report.

   Figure 4-19 Trip Report

   
   Description of "Figure 4-19 Trip Report"
   
   

4. Tap the icon below to add a follow up item.

   Figure 4-20 Add Icon

   
   Description of "Figure 4-20 Add Icon"
   
   

   Figure 4-21 New Follow Up Item

   
   Description of "Figure 4-21 New Follow Up Item"
   
   

5. Navigate back to the trip report, the follow up item will be added to it.

   Figure 4-22 Follow up Item Added

   
   Description of "Figure 4-22 Follow up Item Added"
   
   

4.9 Creating a Trip Report Summary

Perform the following steps to add an item to the trip report check list:

1. In the My Studies pane, select a study and study-site.

2. Tap Trip Reports.

3. Select a trip report.

   Figure 4-23 Trip Report

   
   Description of "Figure 4-23 Trip Report"
   
   

4. Tap the field below Summary to add comments.

   Figure 4-24 Trip report Summary

   
   Description of "Figure 4-24 Trip report Summary"
   
   

5. Type your comments. They will be added to the trip report. To save your changes to CTMS, refer to Section 4.10.

4.10 Saving Trip Report Data to Oracle Siebel Clinical Trial Management System

Perform the following steps to add an item to the trip report check list:

1. Tap a study to view all the sites under it.

2. Tap a site to view all its details.

3. Tap Trip Reports. A list of visits is displayed.

4. Select a trip report for which you want to save data. Visits containing unsaved data are displayed with a red M icon next to them.

   Figure 4-25 Trip Report

   
   Description of "Figure 4-25 Trip Report"
   
   

5. Tap Save to CTMS.

   Figure 4-26 Save to CTMS Prompt

   
   Description of "Figure 4-26 Save to CTMS Prompt"
   
   

6. Tap Save. Your changes will be saved to CTMS and the red M icon is cleared from the visit list.

   Figure 4-27 Trip Report Saved to CTMS

   
   Description of "Figure 4-27 Trip Report Saved to CTMS"
   
   

Fetching Data from Siebel Clinical Trial Management System

You can reset your trip report data by downloading data available on CTMS. Perform the follow steps to reset your trip report data.

1. Tap a study to view all the sites under it.

2. Tap a site to view all its details.

3. Tap Trip Reports. A list of visits is displayed.

4. Select the trip report for which you want to reset data.

   Figure 4-28 Trip Report

   
   Description of "Figure 4-28 Trip Report"
   
   

5. Tap Fetch from CTMS.

   Figure 4-29 Fetch from CTMS Prompt

   
   Description of "Figure 4-29 Fetch from CTMS Prompt"
   
   

6. Tap Yes.

   Figure 4-30 Trip Report Data Fetched from CTMS

   
   Description of "Figure 4-30 Trip Report Data Fetched from CTMS"
   
   

4.11 Submitting a Trip Report for Approval

The work flow process in CTMS can be configured in Mobile CRA. For more information on your status flows, consult with your configuration teams. CTMS lets you select the reviewer and approvers for the Trip Report. Currently, this activity must be done in CTMS, and the result fetched to Mobile CRA, in order to submit from Mobile CRA to the work flow.

Perform the following steps to submit your trip report:

Note:

If multiple reports are submitted for the same visit, CTMS will only display the latest report.

1. In the My Studies pane, tap a study to view all the sites under it.

2. Tap a site to view all its details.

3. Tap Trip Reports. The site visits displayed.

4. Select the visit whose report you want to submit. The trip report saved on CTMS is displayed.

5. in the About section, tap Trip Report Status. The following options are displayed:

   Figure 4-31 Trip Report Status

   
   Description of "Figure 4-31 Trip Report Status"
   
   

6. Tap Submitted. The trip report status will be changed to submitted.

   Figure 4-32 Trip Report Status Changed

   
   Description of "Figure 4-32 Trip Report Status Changed"
   
   

7. Tap Save to CTMS. The Sign and Submit screen is displayed.

   Figure 4-33 Sign and Submit

   
   Description of "Figure 4-33 Sign and Submit"
   
   

8. Enter your user name and password and tap Sign & Submit.

   Figure 4-34 Submit Trip Report

   
   Description of "Figure 4-34 Submit Trip Report"
   
   

9. Your trip report will be submitted for approval and you will receive a confirmation.

   Figure 4-35 Submitted for Approval

   
   Description of "Figure 4-35 Submitted for Approval"
   
   

4.12 Viewing an Approved Trip Report

Perform the following steps to view an approved trip report:

1. Tap a study to view all the sites under it.

2. Tap a site to view all its details.

3. Tap Trip Reports. A list of visits is displayed.

4. Select an approved trip report.

5. You can review all findings in the trip report. However, you may not modify it.