Definitions
ePRO (electronic Patient-Reported Outcome) : A digital survey completed directly by subjects, either on-site or remotely at home, using devices like smartphones, tablets, or computers. Unlike an eCRF (electronic Case Report Form), which is filled out by clinical staff or investigators to document clinical data, an ePRO is completed by the subjects themselves.
Subjects : An individual who participates in a clinical study.
ePRO Forms : A survey form created by clinical staff, designed to be completed by the subject. This form serves as the source survey that will later be distributed to subjects. An ePRO Form can consist of one or multiple surveys.
ePRO Records : A survey associated with a subject, created from the corresponding ePRO Form.
Frequently Asked Questions
Must I create an ePRO to collect subject data answers?
Must I create an ePRO to collect subject data answers?
No, you can use an eCRF form included in your investigator visits. However, this approach may risk biasing the subject’s answers, as they might feel less comfortable responding in the presence of the investigator. Additionally, it is not suitable for real-world data collection.
Must I collect email and phone numbers to address an ePRO to my subjects?
Must I collect email and phone numbers to address an ePRO to my subjects?
How is data privacy ensured when collecting subject responses through ePRO?
Only limited personal information (email and/or 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 to ensure privacy. The system follows a privacy-by-default approach, prioritizing data protection from the start.
Can I use Datacapt’s ePRO module alone without an eCRF?
Can I use Datacapt’s ePRO module alone without an eCRF?
What happens if a subject partially completes an ePRO record?
What happens if a subject partially completes an ePRO record?
No worries, all data entries are saved in real-time. If a subject partially completes an ePRO record, they can resume later by reopening the ePRO record.
See the article ePRO Form.
Can a subject modify an ePRO record once completed?
Can a subject modify an ePRO record once completed?
No, once an ePRO record is completed, the subject is redirected to a success page. Any attempt to reopen the ePRO using the shared link will return them to this page, and modifications are not allowed.
Is it possible to send reminders to subjects for incomplete ePRO records?
Is it possible to send reminders to subjects for incomplete ePRO records?
Yes, it is possible to configure multiple automatic reminders using email or phone channels.