Clinical Outcome Assessments (COAs) and copyright: Bridging the gap between practice and copyright law, where are we today?

Life Sciences, Clinical Trials, Healthcare,
  • Wednesday, March 13, 2024

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.

Seeking such permission would seem to be a straightforward process; however, because rights may be transferred at various points in the life of a COA and because there are usually so many stakeholders involved in the development, management, distribution and use of COAs, the identification of COA copyright holders remains a challenge and a pain point for clinical study teams.


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 – the copyright holder or its representative – who can grant permission to use the COA. Infringing on a copyright violates international copyright regulations and carries serious repercussions that can include legal action, monetary damage, study delay, protocol amendments and may ultimately jeopardize and invalidate study results. Although copyright infringement may be unintentional, good faith is not a defense to infringement.

In addition to copyright identification, users of COAs must ensure that they can get access to qualitative information about the COAs and their derivatives such as translations or e-versions. COAs are validated, scientific tools grounded in qualitative research with patients, and access to reliable information and materials about the COAs will be paramount. One may think it is the responsibility of the copyright holders to provide such valuable information; however, in practice, this is not always the case.

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In this webinar, the speakers will cover some of the fundamentals of copyright protection, how it applies to the COAs for their use, translation, and electronic implementation to ensure compliance with all applicable laws and good practices and will provide some insight as to the due diligence process that needs to be conducted to mitigate risk of copyright infringement and misuse of the COAs.

Register for this webinar today to understand the fundamentals of copyright protection and mitigate risk of copyright infringement and misuse of clinical outcome assessments (COAs).


Caroline Anfray, Mapi Research Trust

Caroline Anfray, Director of Collaborations with COA developers/copyright holders, Mapi Research Trust

Caroline Anfray has been working in the field of COAs within the Mapi Group for 30 years, developing expertise in COA management, information, linguistic validation and eCOAs. As the Director of the Author Collaborations at Mapi Research Trust, her team is responsible for developing relationships and strategic partnerships with developers and owners of COAs to manage, license and distribute their COAs worldwide. Currently, as the Co-chair of the ISOQOL TCA SIG, Member of the eCOA Consortium and ISPOR, and Executive Member of the Mapi Research Trust, she actively contributes to the development of innovative processes and solutions to support the COA field evolution, for the ultimate benefit of the patients.

Message Presenter
Cécile Ouahnon, ICON

Cécile Ouahnon, Manager, Legal Counsel, ICON

Cécile Ouahnon is a French-qualified lawyer. She studied private law at the Assas University in Paris. After completing her Master’s in Intellectual Property, she did an LLM in Sydney, Australia, to study common law and international intellectual property and business law. She qualified as a lawyer in 2010 and worked for two years in Parisian law firms specialized in intellectual property and business litigation. She worked for the next 8 years as a corporate counsel for several companies in the audiovisual and pharmaceutical industries. Cécile has been supporting the Mapi Research Trust as Legal Counsel for 6 years and has developed her expertise on IP applied to COAs.

Message Presenter

Who Should Attend?

This webinar is designed for participants in the healthcare and life science industries who are responsible for implementing COAs in their clinical or research studies and who may not be fully familiar with the requirements, constraints and challenges around COA access and use:

  • Healthcare professionals, clinical researchers planning to use or using COAs in their clinical research and practice
  • Pharmaceutical and biotech companies planning to use or using COAs in their research projects and clinical studies
  • Clinical research organizations (CROs), eCOA vendors and IT companies managing COA licensing for their clients
  • COA developers and copyright holders seeking to learn about COA users’ challenges in accessing COAs

What You Will Learn

Attendees will gain insights into the:

  • Fundamentals of copyright and application to the COA field
  • Process to mitigate risk of copyright infringement
  • Various stakeholders involved in COA copyright ownership
  • Responsibilities to expect from these stakeholders

Xtalks Partner

Mapi Research Trust

Mapi Research Trust is a non-profit organization that facilitates access to Clinical Outcome Assessments (COAs) for the entire scientific community. With more than 30 years of experience in the field of COAs and with the online platform ePROVIDE™, which includes databases on COAs (PROQOLID™), claims (PROLABELS™) and guidance (PROINSIGHT™), Mapi Research Trust is the pre-eminent source of information on COAs.

Exclusive distributor of over 700 COAs, Mapi Research Trust is the most trusted name in the distribution of COA instruments.

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