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Shareable URL: https://crucialdatasolutions.atlassian.net/servicedesk/customer/kb/view/75235438

TrialKit is capable of making forms directly available to study participants (subjects) and sending notifications as forms/surveys become due to complete.

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 from their mobile devices using the TrialKit mobile app available on both TrialKit App in the Apple Store (IOS) and Android Google Play or the patient portal on any web browser.

Subjects who use the mobile app can receive instant app notifications and reminders when forms or surveys are due. For subjects who do not use the mobile app, they will still receive email notifications that can take them directly to the patient portal.

Setting up a study for eConsent and/or ePRO

The system default configuration is set up already with the steps detailed below and is necessary to support ePRO capabilities.

1. Enable ePRO (licensing dependent)

   1. ePRO will come enabled out of the box in your studies.

2. Create a Subject role in the study

   1. The role of the subject will come configured out of the box with correct rights.

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

   1. The template study has the email set up on it as shown below.

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Setup a Notification message on any CRF to send the patient any type of notice. This is optional but recommended. Here are a few examples of factors a subject may need to be notified about:

1. How to sign in once they are registered in a study

2. A survey that is due

3. Notice of an upcoming visit

This is accomplished by creating  Email Message (Notifications) for the subject and creating custom Email Notification Distribution Lists for any event.

For example, upon registration or enrollment, you may want the subject to receive a notice of their login credentials. That message could be written like this:

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Hello,

Contained within this email is your sign-in credentials to access the study you are participating in at [SITE_NAME]. Use the links below as options for signing in. You can also register with the same email on the TrialKit app to get full access to all your TrialKit forms.

Patient PIN: [SUBJECT_PIN]

If you have an iPhone or iPad, download the TrialKit app here:

TrialKit app in the Apple App Store

Android devices, download the TrialKit app here:

TrialKit app in Google Play

We recommend that you use the mobile app for convenient access and push notifications. 

If you do not have a mobile device but do have a web browser, then navigate to the following link on the web: Patient Portal

For questions or support, please contact your Site Coordinator.

Kind Regards,

Study Administrator - [STUDY_NAME]

Company, Inc.

(888) 888-0000

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In the message above, notice the dynamic text used in square brackets. This is how the system can dynamically provide the info relevant to 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 study’s registration form. 

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.

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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. Set the form property indicated below

2. Setup the form within the visit schedule or as an eDiary

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Read here on the different ways to configure ePRO diaries for deploying forms at the right time.

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