Summary

This article covers Setting Up A Study With ePRO

Table of Contents

  • Enable ePRO
  • Create a Subject role in the study
  • Create a Subject role in the study
  • Setup a Notification message on any CRF to send the patient any type of notice.
  • Set up a conditional action to fire the notification email to the patient. 
  • Designate which forms should be available for patients to complete on their own from the mobile app or patient portal website.

Datatrak Direct is capable of making forms directly available to study subjects. Data can be directly entered by patients and patients can receive custom notifications for the following events:

1. Scheduled visit windows

2. Intervals starting from a specific visit

3. Specific days and times based on the patient's time zone

4. Event-driven

These are discussed in more detail here.


When the study designer specifies which forms are ePRO forms (as shown further down in this article), subjects can access those forms for a specified period of time, depending on the event type listed above, from their mobile devices using the Datatrak Direct mobile app available on both Datatrak Direct App in the Apple Store (IOS) and Android Google Play.


Datatrak Direct for Patients can also be accessed via a web browser using the Datatrak Direct patient portal on any web browser.


Patients receive notifications and reminders when forms or surveys become due. Notifications come as both emails and push notifications to the app.


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 Datatrak Direct.

 

1. Enable ePRO

    1. Click on the study tab at the top of the page on the navigation bar.

    2. From the dropdown, select Study Configuration.

    3. Once in the Study Configurations menu, click the Functionality tab.

    4. Check the ePRO Enabled Study box. (Remember it comes checked as default) 



2. Create a Subject role in the study


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 type.  Be sure to pick the two rights in the Subject Record Management applications as highlighted below.



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


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


blob1476916513750.png

Patient Email Addresses are by default NOT included in the data extraction applications.  Email addresses are also hidden in the interface framework for all users for patient confidentiality reasons.


4. Setup a Notification message on any CRF to send the patient any type of notice.


Here are a few things a patient may need to be notified about:

  • Login credentials
  • A survey that is due
  • Notice of an upcoming visit
This is accomplished by creating a distribution list for the subject role created in step 2 and creating custom notification messages for any event. 
For example, upon enrollment, you may want the subject to receive a notice of their login credentials. That message could be written like this:


Hello,

Contained within this email is your sign-in credentials to access the clinical trial you are participating in at [SITE_NAME]. Please keep this email for future reference. 


Here is your pin number for signing in:
Subject PIN: [SUBJECT_PIN]

If you have an Apple iPhone or iPad, download the Datatrak Direct app here.

If you have an Android device, download the Datatrak Direct app here.

When signing in on the app, tap the option to Sign In as Patient
Using the mobile app is recommended so you can remain logged in and receive instant notifications of items due, with quick access to complete forms.

If you are unable to use the app on a mobile device or are having trouble with the app, you can always sign-in on a web browser. 
Please bookmark this link for easy reference:
https://participant.datatrakdirect.com/

Once you have logged in, please complete the consent form.
Upon completion of consent, you will receive notifications as other action items become due.

Thank you again for your participation!

Very Best Regards,

Data Manager - [STUDY_NAME]
ACME company, Inc.
888) 999-0000


In the message above, notice the dynamic text used in square brackets. This is how the system can dynamically provide the info relevant for the subject being emailed. Any field name can be used from the form that this message is triggered by. In the example above, [REG_EMAIL] is the email address field from the enrollment form. For that to function, this message must be triggered by a conditional action on the enrollment form. 

5. Set up a conditional action to fire the notification email to the patient.


In the same example from the previous step, a conditional action was set up on the email field itself within the enrollment form.


blob1477063324085.png


6. Designate which forms should be available for patients to complete on their own from the mobile app or patient portal website.


This is a two-step process. 


  1. For patient surveys that are based on scheduled visit intervals in the study, create the form, and designate it as an ePRO form as shown below.
  2. Include that form in the necessary scheduled visit(s) or eDiary configuration. 


blob1477062385328.png


Note: If a single subject has an email address tied to more than one study within Datatrak Direct or there is more than one form due in a single day, the system will limit one notification per day as a maximum. This is to prevent spamming subjects with too many notifications.

Need more help?

Please visit the Datatrak Contact Information page.