To administer a Clinical Outcomes Assessment (COA) in a clinical trial – whether it is the original version, a translation, or in an electronic format – sponsors and practitioners should evaluate whether they need to obtain permission to use it via a specific license.

Potential users must ensure that a thorough discovery process has been performed to identify the true copyright holder or the licensor acting with the copyright holder’s authority. Indeed, it is only these entities who can grant permission to use the COA.

The due diligence process to prevent copyright infringement

COA ownership is often a murky area, and getting to the bottom of who owns a copyright requires due diligence.

Mapi Research Trust has developed a practical workflow for conducting this due diligence that applies to various situations of ownership. It consists of a series of questions to be asked in order to make strategic and informed decisions on the use of a COA.

Download our whitepaper to access our streamlined decision tree.

Read our whitepaper to learn more about:

• Copyright basics
• Roles of stakeholders
• The due diligence process to prevent copyright infringement
• Copyright protection for derivative works: translations and e-versions