Validation of Electronic Systems to Collect Patient-Reported Outcome (PRO) Data—Recommendations for Clinical Trial Teams: Report of the ISPOR ePRO Systems Validation Good Research Practices Task Force

Abstract

Outcomes research literature has many examples of high-quality, reliable patient-reported outcome (PRO) data entered directly by electronic means, ePRO, compared to data entered from original results on paper. Clinical trial managers are increasingly using ePRO data collection for PRO-based end points. Regulatory review dictates the rules to follow with ePRO data collection for medical label claims. A critical component for regulatory compliance is evidence of the validation of these electronic data collection systems. Validation of electronic systems is a process versus a focused activity that finishes at a single point in time. Eight steps need to be described and undertaken to qualify the validation of the data collection software in its target environment: requirements definition, design, coding, testing, tracing, user acceptance testing, installation and configuration, and decommissioning. These elements are consistent with recent regulatory guidance for systems validation. This report was written to explain how the validation process works for sponsors, trial teams, and other users of electronic data collection devices responsible for verifying the quality of the data entered into relational databases from such devices. It is a guide on the requirements and documentation needed from a data collection systems provider to demonstrate systems validation. It is a practical source of information for study teams to ensure that ePRO providers are using system validation and implementation processes that will ensure the systems and services: operate reliably when in practical use; produce accurate and complete data and data files; support management control and comply with any existing regulations. Furthermore, this short report will increase user understanding of the requirements for a technology review leading to more informed and balanced recommendations or decisions on electronic data collection methods.

Comparison of the paper‐based and electronic versions of the Dermatology Life Quality Index: evidence of equivalence

“…Thus, such studies may have wider and reassuring implications not only for the DLQI but also for other PROs within dermatology and across other medical specialties, encouraging early simultaneous validation of electronic and paper versions. Several challenges remain, including interface design decisions, data collection and adapting electronic PROs to target populations, particularly in patients with physical disabilities or other impairments . Nevertheless, this study has demonstrated that when DLQI migrates to an electronic format, scores are equivalent despite an overall slower completion time, which should become negligible with increased use and improvements to the app interface.…”

Evaluation of quality of life using a tablet PC-based survey in cancer patients treated with radiotherapy: a multi-institutional prospective randomized crossover comparison of paper and tablet PC-based questionnaires (KROG 12–01)

“…Notably, when data collection is performed on a wireless web-based application platform, it is necessary to ensure the quality of all electronic systems in each hospital, including application software, server computers, and wireless Internet networking. Recently, the International Society for Pharmacoeconomics and Outcomes Research (ISPOR) ePRO Systems Validation Good Research Practices Task Force reported its recommendations for the validation of electronic systems used to collect PRO data [22]. According to their recommendations, several core elements are necessary for trials to validate electronic PRO administration systems.…”

PRO Data Collection in Clinical Trials Using Mixed Modes: Report of the ISPOR PRO Mixed Modes Good Research Practices Task Force

“…(UAT is one aspect of an extensive system/software validation process that is far beyond the scope of this article. Another ISPOR PRO Task Force report, Validation of Electronic Systems to Capture Patient Reported Outcomes (PRO) Data-Recommendations for Clinical Trial Teams: A report of the ISPOR ePRO Systems Validation Task Force [33], addresses this topic.) According to Coons et al [29], "the purpose of UAT is to determine whether the software complies with the written system specification or user requirements document."…”