Best Practices for Avoiding Paper Backup When Implementing Electronic Approaches to Patient-Reported Outcome Data Collection in Clinical Trials

Abstract

Electronic data capture is fast becoming the preferred method of collecting patient-reported outcome (PRO) data in clinical trials. Data collection can be site-based (clinical study site), and typically collected on a tablet, or field-based (subject's typical environment such as home, school, or workplace), and most often accomplished with handheld devices, such as a smartphone. While site and study subject compliance with protocol-specific data collection procedures using these devices is critical to trial success, so is the robustness of the device hardware and the software these devices use to capture the trial data. Technology failures and/or site or subject resistance to the electronic data capture protocol may lead a subject to record data on paper, which can result in undesirable data challenges. As such, both site and subject compliance issues and technology-related factors must be anticipated to adhere to the ePRO data collection plan. The objective of this paper is to provide the technology industry's best practice recommendations for optimizing ePRO data collection in clinical trials by proposing the inclusion of a planned approach to data collection that includes viable electronic backup strategies so that defaulting to a paper-based backup becomes unnecessary.

Keywords: eCOA; ePRO; electronic patient-reported outcomes; instruments; measures; paper questionnaires; questionnaires.