An ePRO is a questionnaire answered by the participant themselves, rather than filled in by a member of the clinical team. This article covers the vocabulary and the questions that come up most often.
Definitions
ePRO (electronic Patient-Reported Outcome): a digital survey completed directly by subjects, either on site or remotely at home, on a smartphone, tablet or computer. Unlike an eCRF, which is filled in by clinical staff or investigators, an ePRO is completed by the subject.
Subject: an individual who participates in a clinical study.
ePRO form: the survey created by the clinical team, designed to be completed by the subject. It is the source questionnaire that will later be distributed. An ePRO form can contain one or several surveys.
ePRO record: one instance of an ePRO form, assigned to one subject.
đĄ Tip: forms and records have their own separate statuses. See Understand ePRO record statuses for both lists side by side.
Frequently asked questions
Must I create an ePRO to collect answers from subjects?
Must I create an ePRO to collect answers from subjects?
No. You can use an eCRF form during investigator visits instead. However, this may bias the subject's answers, since they might feel less comfortable responding in the presence of the investigator. It is also not suitable for real-world data collection.
Must I collect email addresses and phone numbers to send an ePRO?
Must I collect email addresses and phone numbers to send an ePRO?
It depends on how you want to deliver the questionnaire.
To send an ePRO by Email, by SMS, or through a QR code with participant login, you need to activate Activate Email, Phone Number, and Language in Settings âș Options âș Enable subject personal information.
You can also generate a record with the No invitation option, which requires no contact details. In that case, the questionnaire has to be opened from the platform rather than sent to the subject.
How is data privacy ensured when collecting answers through ePRO?
How is data privacy ensured when collecting answers through ePRO?
Only limited personal information, email address and phone number, is collected and stored in the Subjects module, which is completely separate from clinical data. Access is restricted to authorized users, and personal information cannot be exported. All access is logged and data is encrypted. The platform follows a privacy-by-default approach.
Can I use the ePRO module on its own, without an eCRF?
Can I use the ePRO module on its own, without an eCRF?
Yes.
What happens if a subject only partly completes an ePRO?
What happens if a subject only partly completes an ePRO?
Every answer is saved in real time. A subject who stops halfway can reopen the record later and carry on where they left off. The record stays at Uncompleted until they finish.
Can a subject change an ePRO once it is completed?
Can a subject change an ePRO once it is completed?
No. Once a record is completed, the subject is redirected to a success page. Reopening the shared link brings them back to that page, and no change is possible.
Can I send reminders for records that have not been completed?
Can I send reminders for records that have not been completed?
Yes. You can configure up to five automatic reminders per form, by email or by SMS. See Set ePRO reminders and repeat occurrences.