Configuring ePRO and eDiaries

This article covers the setup and configuration of studies that need to collect data directly from participants. This is generically referred to in TrialKit as ePRO, but also includes the collection of diaries.

Role Permission Assumption: User has access to Study configuration, Form Builder, and role security settings

Access each section via this Table of Contents:

Enable ePRO for Study

This section will guide you through setting up a study for ePRO. New study builders of the system will notice many of the following steps are done already on the template study provided by TrialKit.

1. Enable ePRO

   1. In the Study>Study Configurations menu you will see the Functionality tab.  There, you will check the "ePRO Enabled Study" checkbox.

2. Create a Subject role in the study

   1. In the Role Security tab, you will add a new subject Role with settings as displayed below.  The subject must have a hierarchy of 0 and SITE as the Role Type.  Be sure to select the two rights in the Subject Record Management applications as highlighted below.

      Open

      

3. Setup the initial registration CRF to collect the subject's email address

   1. In the Form Builder, open the form that is being used as the initial registration form (defined here). Drag an email address field (1) onto the form and identify that field as the Subject Email, as shown below.

   2. Be sure to select “Subject Email” in the Special Type dropdown box (2) in the field properties. This setting will appear when the email field is selected.

Defining the ePRO Forms

The following form properties must be set in the Form Builder for any form that will be entered by the Participant:

• ePRO Form

If the form needs to be collected repeatedly as an eDiary (described more in the next section), the additional properties are needed

1. Record Relation: Many

2. Log Form: checked

3. ePRO Form: checked

ePRO Forms Visit Date

Visit Dates are defined on any subject-type form. ePRO forms are no different, but the system will do something different with this date during data entry. When a participant opens the form to complete, this date will auto-fill with the user’s current date/time (based on their timezone preference).

Ways to collect forms/surveys from study participants

There are four methods of getting forms delivered to study participants depending on the requirements for frequency and notifications:

• Forms collected within the visit schedule design

• eDiaries - All detailed more in the next section

  • On a defined interval (weeks, days, or hours), up to hourly

  • On specific days and times of the week, up to hourly

  • Based on an event - some other interval diary triggers this diary. These can run up to every minute.

Window of availability to the Participant

Forms will be available for completion based on the parameters of the completion window. If the form is part of a scheduled visit, this is simply determined by the high end of the visit window. If the form is collected as an eDiary, the completion window (described further below) will dictate when the form disappears from the Participant's view, regardless of the status of the form.

To give Participants continued access to forms that have been entered in the past, but where the completion window is expired, enable the study function - Enable access to unlocked forms.

Configuring eDiaries

Within the study configuration menu, currently only available to set up via the mobile app, select eDiaries.

To create an eDiary, add a new configuration via the form displayed. See the image and descriptions below.

Name - Give the eDiary a configuration name. The subject/patient will see this title, along with the study name, when the associated form(s) are delivered for collection

Starting Interval - This will be the visit interval within each subject's casebook that initiates the diary. In some cases, it may be necessary to set up a “dummy” visit within the schedule if there is not already an inherent visit in the study design to use.

Expiration - How many total days from the starting interval should the configuration run for.

Time Unit - Days, hours, or minutes can be used to deliver form(s) in a very specific interval.

Completion window - For each form delivered, how long the patient will have to fill it out within a given interval. For forms that are always available (i.e. Interval type with “0” frequency), the completion window will not be enforced since the user can fill out a form at any time.

Form Selection - Tap to select which form(s) apply to the configuration being created. Forms will only be displayed as options if they are set up (via the form builder) with both the log form and ePRO form properties as described in the “Set Up Forms as eDiaries” portion of this article.

eDiary type - There are three different methods for collecting ePRO forms:

Specific Time 

Choose specific days and times to collect the forms. For example, every Tuesday and Thursday at 0800 (patient’s local timezone).

It's important to include time in the visit field of the diary form and to consider any overlap of other diaries or time windows. Here are a few examples:

1. If a diary is set to go out at 6 pm and expire after 8 hours, there is an overlap into the next day. If the diary is completed at 1 am, then the system thinks the diary is complete for that next day.

2. If the visit date defined on the diary form does not include time, the system will assume it was saved at midnight whenever the patient saves it, which may prevent it from not disappearing from the patient’s list of forms due.

Interval 

Choose a repeating interval to collect the forms. For example, every 3 days. Frequency and Maximum forms are factors also set within this diary type. 

• Frequency is the interval based on the time unit selected above. To make a diary “Always Available”, set this zero (notifications do not apply to a value of zero)

• Maximum forms are how many can be filled out within the given diary and its expiration period. Example: If a diary has a maximum of 3 forms and an expiration of 90 days, the diary will stop running (deploying forms based on the frequency) once the 90 days is reached or once 3 records are saved for a given subject - whichever comes first.

Event-Driven 

Another designated Interval Diary form saved by a Participant will trigger the start of the event-driven eDiary. Once that begins, a specific frequency (up to every minute) occurs for a specified number of total records being collected.

For example, when a patient indicates that they have experienced nausea on Diary “A” form (via a separate eDiary configuration), deliver a follow-up form via Diary “B” (Event-driven) every 2 hours until 4 records have been collected (8 hours total). Once the 8 hours have passed, the trigger form will be available again based on that separate diary configuration.

Factors to Note:

• Events cannot be nested. Multiple of the same triggered events cannot be in process at once. Similar to the Interval type above, Frequency and Maximum forms are factors also set within this diary type. 

• Even-driven diary notifications are enabled by CDS on a per-study basis. The diaries can be configured to deploy, but users will not receive system notifications without appropriate licensing.

Notifications to Participants

Participants will receive notifications anytime a form becomes due, based on how the Visit schedule or eDiary is configured. Here are a couple of examples:

• 6-month follow-up visit includes an ePRO form. The Participant will receive notification on the low date of the visit window. The form will remain available for the duration of the visit window and may also receive reminder notifications depending on the Notification configuration.

• The Interval diary goes out at a frequency of once per day for 10 days after the 3-month follow-up visit. Starting on the 3-month follow-up visit, the participant will begin receiving daily notifications until the diary expires in 10 days or the maximum forms have been entered.

There are three reasons notifications will NOT go out when a form becomes due:

1. Notifications are not configured. Read more here on Configuring Notifications.

2. Notifications have not been allowed in the eDiary settings - detailed in the section above

3. The form is collected in an hourly-based visit schedule. Visit schedule forms are limited to one notification per day. The first notification will go out based on the visit window, but if there is another visit in the following hours of the same day, a notification will not go out. Only the form will be due to complete. For hourly notifications, use an eDiary rather than a visit schedule.

4. The ePRO form is defined to not send notifications

5. The visit window is not active or has already sent a notification for the current window

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