Understand what eCOAs entail and what modalities are involved, as well as the current regulatory expectations, in order to choose the right vendor when migrating from paper to electronic formats
eCOA Use, Validation, and Equivalence: To Be or Not to Be?
Electronic data capture within clinical trials can enhance the quality and reliability of study data; consequently, electronic clinical outcome assessments (eCOAs) have seen increased use and popularity over the years. With the continual advancement of technology, the use of eCOAs is becoming more the norm. There are, however, still relevant questions about which technologies to use, what type of evidence is needed for regulatory submissions, and how those requirements may vary from more traditional "pen and paper" methods.
 
Featured Presenters
Mona Martin
Mona Martin, MPA
Senior Research Leader
Patient-Centered Research
Evidera
Huda Shalhoub
Huda Shalhoub, PhD
Research Scientist
Patient-Centered Research
Evidera
Discussion Points

This webinar will present:
An overview of the eCOA landscape
Different modalities, including bring your own device (BYOD)
Industry-level guidance on COA migration
Important criteria to consider when selecting an eCOA vendor
Topics such as validation and equivalence testing
A discussion of best practices for optimal success
Key Learning Objectives
Understand what eCOAs entail and what modalities are involved
Gain a deeper understanding of current regulatory expectations and the latest guidance documents on the topic
Distinguish between different levels of evidence needed, and potential additional validation work required, when migrating from paper to electronic formats
Increased confidence in decision making and comprehension of key considerations in eCOA vendor selections
Become familiar with eCOA migration best practices
 
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Related Resources
 
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Fact sheet: Patient Engagement and Insight
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