What is eCOA?

eCOA is the digitization of paper versions of Clinical Outcome Assessments (COAs), enabling electronic capture of data. Prior to going live, the process of digitization and eCOA implementation must be robustly tested to validate the integrity of measurement properties.

COA digitization and eCOA implementation: challenges and solutions

COAs are scientific and copyrighted material which undergo a long and rigorous validation process of their measurement properties. It is therefore critical that the electronic version (eCOA) is equivalent to the paper version (original COA).

To minimize the risks faced during the digitization, Mapi Research Trust has developed an end-to-end workflow relying on active collaboration between COA developers, sponsors and eVendors:

1. eCOA licensing: Mapi Research Trust can assist with the licensing of any COAs.
2. Definition of the digitization scope: On which devices will the eCOA be administered? Will Bring Your Own Device (BYOD) be permitted?
3. Provision of a COA-specific eBooklet: Guidance on the digitization requirements, developed by Mapi Research Trust in collaboration with the COA developer.
4. Feedback during digitization: The eVendor manages the digitization and can request feedback from Mapi Research Trust on how to faithfully migrate from paper to electronic version, while meeting the needs of the sponsor/protocol.
5. Review of the eCOA: Mapi Research Trust performs screenshot reviews to evaluate the digitized COA* against the eBooklet and eCOA best practices, and identifies any required updates.
6. eCOA certification: Delivery of the eCOA’s certification package.

*Modifying a COA, whether in terms of content or design, without validation from its developer or legal representative presents significant risks in terms of data validity, possible legal repercussions and even delaying the launch of the clinical trial.

Mapi Research Trust’s eCOA services for successful implementation

To ensure equivalence between the eCOA and the original COA version, and to ultimately secure the validity of the eCOA measurement properties, Mapi Research Trust has developed a set of complementary services dedicated to eCOA implementation:

• User Guide for eCOA Implementation

Developed to outline the latest eCOA best practices and recommendations from health authorities and eCOA expert groups, and our own in-house expertise. Our eCOA Services team is available to work with eVendors and sponsors to advise on these best practices, assess eCOA platform capability and outline optimal workflows.

• eBooklets

Developed in collaboration with COA developers and eCOA technical experts, eBooklets provide digitization guidelines specific to each COA. They include detailed instructions on the architecture of the questionnaire, such as workflow diagrams on the conditional logic, screen order, instructions on question skipping etc., plus important details on content formatting.

• Screenshot review and Certification

Performed by a dedicated team which reviews the eCOA screenshots for alignment with the eBooklet and eCOA best practices. They provide a report identifying both required and recommended changes needed to meet equivalency with the COA’s original version.  Once all agreed changes have been made, the eCOA certification package is provided.

• Expert Review

This is on-device testing, done to review the overall usability and functionality of the eCOA. This is performed in certain scenarios, such as when Bring Your Own Device (BYOD) is used in a study or when it is a requirement of the copyright holder.

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