Training on the Use of Technology to Collect Patient-Reported Outcome Data Electronically in Clinical Trials: Best...

Area of Science:

• Clinical Trials
• Health Informatics
• Data Management

Background:

• Electronic patient-reported outcome (ePRO) data capture offers significant advantages over traditional paper-based methods in clinical trials.
• Regulatory agencies endorse ePRO systems and emphasize the need for comprehensive training for both participants and site staff.

Purpose of the Study:

• To establish best practice recommendations for training end-users on ePRO technology in clinical trials.
• To ensure consistent, accurate, and complete data collection through optimized training strategies.

Main Methods:

• Training recommendations encompass both study-specific and technology-specific knowledge for site personnel.
• Utilizing a multi-modal training approach over time, including hands-on, remote, and self-paced e-learning.
• Providing participants with initial hands-on training and ongoing access to interactive electronic modules.

Main Results:

• Site staff require training on study protocols, ePRO system usage, and technical support contacts.
• Participants need individualized, hands-on training at trial initiation, supplemented by accessible on-demand electronic modules.
• A structured training framework is essential for maximizing the benefits of ePRO data collection.

Conclusions:

• Implementing structured, multi-modal training for both site staff and study participants is key to successful ePRO adoption.
• Optimized training enhances data quality and leverages the full potential of ePRO systems in clinical research.
• Adherence to best practices in ePRO training ensures reliable and efficient data capture in clinical trials.