Best Practice Recommendations for Electronic Clinical Outcome Assessment Data Changes

Abstract

Historically, there was a tendency amongst electronic clinical outcome assessment (eCOA) service providers and their sponsor clients to prevent changes to eCOA data, particularly for electronic patient-reported outcome (ePRO) measures, or to allow changes to eCOA data but only after receiving sponsor approval to do so. Further, sponsors were also approving or denying data change requests (DCRs).From 2018 to 2022, 45 representatives of Critical Path (C-Path) Institute’s Patient-Reported Outcome (PRO) Consortium, eCOA Consortium (previously ePRO Consortium), and the eClinical Forum collaborated to develop guidelines on changes to eCOA data. These were compiled into the present manuscript, which outlines best practices aligned to latest health authority guidance, and based on expertise from all three organizations.This work coincided with a shift in clinical trial industry practices and emergence of regulations and quality functions that require that investigative sites, not sponsors, be responsible for the maintenance of accurate source records. In other words, the question was not whether, but how, PRO data should be changed. The resulting set of core principles can become the foundation upon which sponsors, investigators and eCOA providers can work together on DCRs.To achieve that, eCOA studies must:• be setup in a manner that minimizes potential user errors;• have a documented oversight plan and documented site staff training;• follow clearly defined and standard workflows–but also mitigate undefined change types;• allow trial documentation per ALCOA+ principles; and• induce sponsors into timely reviews and reconciliations of discordant data (i.e., via sensitivity analysis) and not by arbitrarily overruling the investigators.