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

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.

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).

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
• Due diligence process to mitigate risk of copyright infringement
• Various stakeholders involved in COA copyright ownership and responsibilities

Speakers