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Addressing challenges with eCOA at the site-level

11 January 2024

The eCOA: Getting Better Together Initiative launched by the Critical Path Institute in 2019 aimed to identify and address issues with eCOA implementation in clinical trials. The Support Flexible Approaches to PRO Data Collection project, part of this initiative, focused on three key areas:

  • Innovations in technology to support flexibility in eCOA use.
  • Expectations of measure owners and regulators regarding eCOA.
  • Impact on clinical trial sites and CRAs.

This article concentrates on the third area, exploring the challenges faced by site staff and CRAs with eCOA and gathering suggestions to simplify and increase flexibility. A web-based questionnaire was developed and distributed via snowball sampling to trial site professionals and CRAs for anonymous feedback. The research covered various aspects such as study oversight, solution-related issues, helpdesk experiences, eCOA backup preferences, and general recommendations for improvement.

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