ePRO allows subjects to report their trial experience electronically via phone, tablet or computer, replacing paper forms.
In clinical trials, another common term associated with ePRO is eCOA. This term refers to all results recorded electronically, including results reported by patients or volunteers.
The benefits of using ePRO in clinical trials are numerous, both for subjects and for clinicians and investigators, and this paperless data collection process has the potential to significantly improve the overall study experience for subjects.
ePRO has several advantages when it comes to processing and understanding your study data. Since subjects enter their results directly into a digital format, depending on the features of your ePRO questionnaire that you define, you and your team will be able to monitor, analyse and react to the data collected.
Main benefits
1. Error detection and prevention
Data entry errors resulting from human error are unavoidable and validation checks are totally absent from paper-based data collection methods. Allowing data to be entered electronically using an ePRO will significantly speed up the process and allow data to be entered and checked directly into the system, rather than being entered manually by medical staff.
2. Improved regulatory compliance and a traceable audit trail
Many EDC and ePRO systems have an audit trail function, whereas paper-based systems and spreadsheets often make it difficult to track data changes.
3. Different data table options
Manual tabulation is a huge drawback of paper-based data management. The more complex the study, the more difficult, time-consuming and costly the corresponding resources you will have to invest. With ePRO, once constructed, data tables can be adapted and exported in multiple formats, saving you time on an otherwise tedious task.
4. Enhanced data security
Potential data security risks are a concern in the clinical research sector. The EDC and ePRO solutions provide role-based security, making user permissions and rights highly configurable to ensure that only authorised persons within the study have access to their data – a feature that is almost impossible with paper or Excel questionnaires.
5. Simultaneous data entry by multiple users
Paper-based solutions do not allow multiple stakeholders to work on the same data simultaneously. In addition, working with multiple spreadsheets, documents and versions can lead to discrepancies and misplaced data. ePRO allows multiple team members to manage and control data at the same time, and subjects can also enter their data. This gives them more control over their participation in the study and improves patient engagement.
6. Increased capacity
Managing data in Excel or on paper means that you are only able to enter and review data. ePRO gives you access to a wide range of features such as simple and flexible form construction, real-time tracking, automatic questionnaire sending and reminders.
Datacapt's ePRO solution
Datacapt ePRO allows you to design your questionnaires in a few clicks thanks to an intuitive and easy-to-use interface.
Track responses and results in real time, as well as plan the sending and follow-up of your forms in a few moments.
Direct access to the data collected while ensuring optimal security.
It is a dedicated, secure and multilingual space for each participant to ensure a unique user experience. This increases the engagement and retention of your participants.
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