Electronic Clinical Outcome Assessments (eCOAs) are exponentially used in clinical research and practice. Although regulatory agencies and working groups have published guidance on eCOA development, issues and ambiguities are still encountered in practice by the various stakeholders during the COA electronic migration process. It is therefore essential to provide clinicians, sponsors, and vendors with practical and up-to-date migration guidelines, which are specific to each COA and validated by their developers to secure the COA integrity and optimize the user's experience.
What you will learn
In this talk we will discuss:
- What is important to consider when implementing a COA to electronic format
- What challenges are faced in the digitization process
- How to streamline screen review and certification process
Attendees will learn about solutions to handle common and sometimes complex digitization issues. They will also get a demo of guidance included in the eBooklets to help with development of COA to electronic format.
eCOA Account Manager, Mapi Research Trust
eCOA Project Lead, Mapi Research Trust