Whitepaper | The COA licensing process: How to prepare for success

It is incumbent upon sponsors intending to use COAs in a clinical trial to plan for obtaining permission early in the study planning process and to understand how the licensing process works.

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.


In this whitepaper, we cover the prerequisites for controlled use of COAs and provide suggestions for streamlining the licensing process, which can be complex and typically involves multiple parties.

This whitepaper details:

  • Copyright law 101
  • Where to turn for permission
  • Where to turn for scientific help
  • An overview of the licensing process, including translation and digitization
  • Timeline planning
  • The most common pitfalls
  • Best practices for success

The copyright holder and/or distributor/licensing company manage the legal and administrative aspects of copyrights. They are the only entities that can grant the right to use a COA that is not in the public domain.

A license for use provides access to the official COA original/source version and validated language versions as well as the appropriate scoring method and interpretation guidance. The license often also grants permission to develop any additional needed material (such as new translations and electronic versions) and to disseminate and publish study results in the scientific literature. Users who wish to modify the content or layout of the COA need to obtain express permission to do so during the licensing process.


The COA licensing process: How to prepare for success


COA licensing process key takeaways

  • Seek permission from the copyright holder and follow licensing requirements
  • Identify and mitigate upfront any potential risks to COA / eCOA implementation
  • Consider all dependencies when building study timelines for your COA implementation
  • Optimize your chance of success by involving appropriate stakeholders for their individual area of expertise