eCOA Data Changes

Best Practices for eCOA Data Changes

ePRO is a mechanism for the patient to enter data directly into an electronic device or system.  These data are transferred directly from the technology to the ePRO provider, which eliminates the transcription that was required by site personnel with measures completed on paper.  There are other types of assessments and outcomes performed throughout a clinical trial.  The term clinical outcome assessments (electronically would be eCOA) is used to cover all categories of assessments completed.  For assessments completed by clinicians, the data changes permitted should be aligned with the protocol.

This team has the responsibility to explore data changes for patient-reported outcome measures collected electronically, (known as eCOA or ePRO) and to discuss the best practices and implications of different methods. This team began as an eClinical Forum team, and then realized that C-Path had a similar initiative, and the two groups joined to work on a deliverable encompassing experiences of subject matter experts from both groups. The paper has been submitted for publication and should be available 4Q 2022.