Insights for optimized selection and implementation of COAs and eCOA in clinical trials

COAs and copyright:

How to mitigate risks of infringement and misuse in clinical research and practice

In this whitepaper, we cover some of the fundamentals of copyright protections and what is involved in identifying the copyright holder of a COA.

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Digitizing Clinical Outcomes Assessments (COAs):

A streamlined approach to approval

In this whitepaper, we review the main steps in creating electronic forms of paper COAs, identify the common risks and challenges of doing so, and share the strategy that Mapi Research Trust has in place to streamline the process.

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The COA licensing process:

How to prepare for success

Sponsors intending to use COAs in a clinical trial must secure permission of use early in the study planning process. Failing to seek permission from license holders at the appropriate time can not only jeopardize trial timelines and costs, but can also have legal consequences. This whitepaper covers the prerequisites for controlled use of COAs and provide suggestions for streamlining the licensing process.

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Keeping eCOA implementation off a trial’s critical path

A best-practice approach

This whitepaper developed in collaboration with ICON plc describes the sequence of events involved in the development cycle of eCOA (COA licensing, translation, eMigration, User Acceptance Testing) and presents a recommended approach to planning and implementing eCOA to mitigate the risks of delaying the study start up.

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