Clinical Studio is capable of making forms directly available to study subjects so data can be directly entered by patients and patients can receive custom notifications based on any event. 

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 Clinical Studio patient portal on any web browser or the TrialKit  available in the Apple Store form any Apple mobile device.


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.


This section will guide you through setting up a study to accomplish all of the above. New users of the system will notice the first five steps below have already been done on the template study provided by the system.

 


1. Enable ePRO

 

Enable the ePRO function in the Study Configuration as shown below.








2. Create a Subject role in the study

 

A) In the Study Configuration Role Security, if the subject or patient role does not yet exist, create a new role in the study for the Subject and give it a hierarchy of zero. Studies created after December 2016 will already have this.


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B) Two permissions in the application called Subject Record Management will need to be updated.

  1. Select Subject Role and Application "Subject Record Management"
  2. Check two role rights "Add Subject Event Records" and "Edit Subject Event Records"
  3. Remember to click SAVE RIGHTS button at bottom of page.



C)  Update Form Rights that subjects will enter data in


1) Click on Role Security Tab

2) Verify Editing of Role Rights of the Subject 

3) Click on "Switch to Form Rights" 

4) Click on proper rights for form.  (Read/view only or Read and Edit rights)

5) Be sure to hit "Save Rights" button






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.




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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 the 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 are 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 download

We recommend that you use the mobile app. It will provide you with a window that when tapped, you can complete your survey forms. In addition, you only need to Sign In once. 


If you do not have a mobile device but do have a web browser, then navigate to the following link to access the system:

Patient Portal


You can navigate to the above link and use your sign in credentials to access your survey forms. E-Mail reminders will be sent out prior to survey forms coming due so be sure to check your email.


Very Best Regards,


Data Manager - [STUDY_NAME]

Company, Inc.

(888) 888-0000





-----------------------------------



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. Setup a conditional action to fire the notification email to the patient.


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



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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)




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Some surveys may not be part of scheduled visit intervals, particularly with patient e-diaries or other forms that you want to collect from the patient at a regular interval. Here's how to configure a form of that nature.



Note: If a single subject has an email address tied to more than one study within Clinical Studio 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.


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 confidentiallity reasons.