How can I edit ePRO settings? (Step 4)

⭐ Good to know: 

Each ePRO step generates a unique ePRO weblink. If you need to send out multiple ePROs (e.g., questionnaires) at different points in time throughout the study, create a separate ePRO step for each.

For example: ePRO at V1, ePRO at V3 etc.

If you want to send out different forms (questionnaires) simultaneously or have them completed on the same day, you can include multiple forms within a single ePRO step. 

A subject template is provided, however, it is fully adjustable. If you use the tag "{{step_name}}", the name of this ePRO step (see 2) will be automatically populated in the email subject.

You also have the option to specify a generic "reply-to email" for all ePRO steps at once. Read the following article for more information: How do I create and edit a study workflow (Step 4)

How can I set up a study?)

You can also customize your message. This text will be displayed to the subjects when sending the email. Please remember to always include the {{link_here}} tag when customizing your the body. The system generates an individual link per subject, which is automatically filled.

International studies: 

If you are conducting an international study in which several languages are created, please use the Primary Language that you selected in Step 1 General. You can add the text (subject and body) for all secondary languages in Step 6.

⭐ Good to know: A single (completed) SMS can contain up to 160 characters. If you want to send a longer message, it is divided into several parts and contains only approx. 153 characters per SMS. This means that two SMS messages contain a maximun of 306 characters and three SMS messages contain a maximum of 459 characters. The character composition is as follows:

• ePRO link (= domain + 22 characters)
• Text of your SMS
• Example: https://knowledgebase.climedo.de/en/epro/XXXXXXXXXXXXXXXXXXXXXX
  + Text
• Line breaks count as one character, a blank line counts as two characters.

From a subject's perspective, only "one" SMS is received. However, in the background it may be composed of several SMS depending on character length.

Please note that the costs for sending ePRO SMS are based on the actual number of SMS messages sent in the background. For further details, please contact your Customer Success Manager.

Manual request requires a user to actively trigger each ePRO per subject in the eCRF/study. It is used if an automated trigger cannot be fully specified or for backup ePROs.

ePROs on enrollment are sent out as soon as the subject was enrolled in the study. The user will need to enter the email and/or mobile phone number upon enrollment.

⭐ Good to know!

For ePROs sent out on enrollment, at least one form must be visible by default to allow for data collection, because a dependency visibility can only be triggered after enrollment and subsequent data entry. Even if the input form becomes visible after the data entry, the sending of the ePRO is not triggered again.

For manual ePRO request at least one form must be visible at the time of ePRO send-out. Visibility can be by default or triggered by a dependency.

Finally, you have the option to send the ePRO at a scheduled time. If you select this option, you can choose between three options.

First, you can initiate the sending based on the enrollment of the subject, at a certain time after the enrollment (e.g. the next day at 2pm).

Second, you can send the ePRO dependent on the visibility of the input form(s) within this ePRO. To do this, you must create a dependency on the input form(s) used (see Step 3.1.3). Read more about dependencies between forms in the following article. As soon as you have created a dependency for this input form (example: in connection with the eligibility question of the baseline visit), the ePRO will be sent at the scheduled time after the dependency has triggered the visibility of this form (e.g. one day after answering the eligibility question with "yes" at 5pm).

⭐ Good to know! 

For ePROs sent based on form visibility, any visible form will count as the trigger for scheduling. This means that all your forms in the ePRO should be involved in a dependency. Whichever form becomes "visible" first will trigger the send out schedule, including a form that is visible by default.

Third, you can send the ePRO dependent on a date or date & time field input. An example would be to schedule an ePRO to be sent exactly 14 days before or after a surgery date that was entered for a specific subject into a visit form. 

⭐ Good to know!

• If an input field is used in an ePRO scheduling setting, it is not possible to delete the input field, the form the input field is included in or remove the form from the respective workflow step in study setup. The form first needs to be removed from the ePRO setting, before a deletion can be executed. 
• A past date has been entered to the input form: In case the study personnel forgot to enter a date connected to the ePRO scheduling too late, e.g. the ePRO was supposed to be sent 5 days after the entered date on the 01.05., but the date was only entered into the eCRF on the 10.05., the ePRO will not automatically be sent, but needs to be triggered manually. However, if it was only supposed to be sent out after 10 days, meaning on the 10.05., it will be sent as planned. 

You have the option to send one or several reminders to the subjects if they have not yet completed 100% of their questionnaire, and as long as the corresponding ePRO weblink has not expired (see 12). The weblink and the text of the reminder corresponds to the text of the initial SMS/email (see step 3.2).

⚠️ Attention: The progress of the questionnaire is measured by the fields that have been marked as "required". If you have marked only one field as required, the system will register the questionnaire as 100% completed as soon as this field has been filled. If you have not marked any field as required, the system will consider all questions for the progress calculation.

Last but not least, you can set the point at which the questionnaire should no longer be accessible to the subjects, meaning the corresponding weblink has expired. This setting is always based on the day of the initial send out. For example, if you specify "in 3 days at 5pm", the subjects have 3 days (until 5pm) after the ePRO weblink has been sent to open this questionnaire and enter data.

When you defined all settings, click on "update step" and remember to save your changes in the general editing interface.

 ⭐ Good to know:

1. You can schedule to send out the ePRO in up to 5,000 days.
2. The schedule is always in "days" plus the "actual time" (e.g. 16:35). At the moment, it is not possible to schedule an ePRO to be sent in 5 hours and 30 minutes after a trigger.
3. At the moment, you cannot automatically schedule ePROs on a variable date planned in the future, e.g. to send ePROs based on the next planned visit date. Contact your Customer Success Manager for alternative options for such use cases.
4. In the workflow, you can also set whether consent should be requested from the subject before answering the first ePRO. Read more about this in the following article: How do I create and edit a study workflow (Step 4).
5. Data is being saved automatically in real time. It is not necessary to click on “save/ submit” button. But please note that this is only possible with an internet connection.