Reflections on the Optimal Use of eDiaries for Data Collection in Vaccine Clinical Trials.

Abstract

Recent years have witnessed a transformative shift in the way patient-reported outcomes are captured. The increasing adoption of digital health technologies offers exciting possibilities for more efficient, engaging, and insightful data collection electronically. Regulators recommend that the source data captured electronically should adhere to Attributable, Legible, Contemporaneous, Original, and Accurate principles to ensure data quality and integrity and be compliant with regulatory requirements. Traditionally, paper diaries are used to collect safety data in clinical trials; however, electronic forms of these paper diaries represent a paramount resource that could improve data quality, reduce costs, and limit the burden on clinical staff and trial participants. Electronic diaries (eDiaries) offer significant advantages, but specific measures must be taken to ensure their optimal use. In this paper, we provide our reflections on key measures, such as programming the eDiary platform, training the trial staff and participants, and real-time monitoring of participant compliance, to leverage eDiaries for optimal data collection. By implementing the measures discussed in this paper, eDiaries can offer significant advantages for both trial participants and clinical investigators by ensuring the quality and integrity of the data collected.