Roadmap: Starting a visit and entering data

1

Select the patient.

1. Select Patients ().
2. Search by Status, Patient List, Site Name, Patient ID, or ePRO session.

2

Select the visit.

• For the next scheduled visit:
  • In the Visit Name column, select the Visit Name link.
• For a specific previous or future visit:
  • Click the Summary link for the patient.
  • Click a Visit link.

3

Record the date and time of the visit.

On the Visit Landing page, in the Actual Visit Date field, enter the date and time. You must complete the Visit Landing page if the form is included in a visit.

4

Select the form.

Your study might be set up to display the first form for the visit automatically upon submission of the Visit Landing page. You can also select the form from the navigation pane on the left.

5

Enter the data.

As you enter data, the OutcomeLogix application identifies any required fields and might provide additional information about the expected entry.

6

Submit the form.

or

Click Save Only to save the data you have entered without submitting the form. You can return to the form later, complete it, and submit it.

When you submit the form, the OutcomeLogix application validates your entries and does not accept the form until all entries are complete or the OutcomeLogix application has issued queries for missing or unexpected entries. The application displays a Query Status icon next to each Answered, Closed, or Approved query.

When you click Save Only, the application saves the patient data entered without executing server-side validations and changing the form status to In-Progress. However, the OutcomeLogix application might require you to correct field entries before performing the Save Only function.

The Save Only function may not be enabled for a given study.

7

Complete the rest of the forms.

Your study might be set up to display the next form automatically, or you can select it from the navigation pane on the left.

8

Edit the forms as necessary.

When you submit a revised form, the OutcomeLogix application prompts you to enter a reason for the changes and tracks the revisions in the Audit Trail for the form.

1. Select the form.
2. Edit the fields as necessary.
3. Click Submit.

9

Complete the Reason for Change window.

1. For each item, select the reason you changed the field value from the Reason drop-down list. If you selected Other, type the reason in the Response text box.

   or

   Apply the same reason to all items changed:

   • From the Group RFC drop-down list, select the reason for change. If you selected Other, type the reason in the Response text box.
   • Click the Apply All link.
2. Click Submit.

10

Sign the patient, visit, form, or item.

Signatures at the patient, visit, form, and item levels are independent of each other. You must sign at each level.

1. Select Patients ().
2. Click the Summary link for the patient.
3. Select the checkbox to the left of the patient, visit, form, or item.
4. Click the Sign icon ().
5. From the Reason drop-down list, select the reason for your signature. If you selected Other as the reason, type an explanation in the Reason text box.
6. Type your User Name.
7. Type your Password.
8. Click Submit.

   The application displays the Signed status icon in the Manual Actions column for the form. The Signed status icon also appears on the Patient Summary page.