Clinical Outcome Assessments (COAs) are questionnaires developed by scientists to measure the impact of a disease or treatment on patients’ quality of life. This scientific and literary material is protected as intellectual property and by copyright laws.
A lack of awareness or consideration of a COA’s copyright can have substantial impacts on a clinical trial. A few examples include copyright infringement and legal action, reputational damage, study delay, protocol amendments, and invalid results.
To minimize risks, sponsors should be aware of the implications of copyright and anticipate the licensing of a COA as early as possible in the study startup plan. Here we intend to give you the keys to better understand the copyright, how to obtain permission to use a COA, and what rights are granted to users with a license to use a COA.
Definition of copyright
Copyright is the legal right that protects the intellectual property of author’s work produced in tangible form. Copyright is automatic and does not require official registration. The copyright owner has control over the work and a right to make and authorize copies, modifications, translations, to publish and display their work, or use in any way. It means that any use of the work requires permission from the copyright holder, generally provided in the form of a license.
The duration of the copyright starts from the work’s creation date and lasts for a minimum of 50 years after the author’s death. In most European countries and in the USA, it often applies for 70 years after the author’s death.
COAs and copyright, how to obtain the permission to use?
COAs are copyrighted material, unless in the public domain. Due diligence should be performed to assess a COA’s status. To administer a COA in a clinical trial, whether it is the original version, a translation and/or an electronic version (eCOA), sponsors must secure permission to use it with a study-specific license when appropriate.
The study-specific license can be obtained with a licensing agreement signed between the intended user of the COA (sponsor) and the copyright holder or the licensor acting on behalf of the copyright holder. The contract typically includes information on the terms and conditions of use of the COA, scope of use, licensing fees and rights granted to the user.
What information is typically needed for a license to use a COA?
To set-up a license, the licensor needs information on the clinical trial including:
- Name of the COA (acronym and full name)
- Developer(s)’ name and bibliographic references
- Version intended for use (short or long, various modules)
- Languages (country specific, e.g. Spanish for Spain, Spanish for Argentina, etc.)
- Study/protocol number
- Project dates (start and end)
- Number of expected patients
- Number of administrations
- Mode of administration (paper, electronic, both)
- Project funding/sponsor (if applicable)
What rights are granted with a license to use a COA?
As previously stated, licenses are study-specific and the license grants the right to use the COA and derivative works (translations and/or electronic versions) in the designated clinical trial. Fees may apply for the COA’s use, whether copyrighted (royalty fees and service fees) or in the public domain (service fees). If a sponsor intends to use the same COA in several clinical trials, different licensing agreements may need to be signed for each trial.
For more details on the key steps of COA licensing, risks, and mitigation plans, read our Blog “How to successfully prepare the licensing of Clinical Outcome Assessments”.
Conditions of use
Copyrighted COA = under license
No copyright = Public domain COA
Access to the COA
Through the licensor with a license agreement.
Free from copyright. No license agreement needed.
Access to all COA-related material (translations, scoring information, guidelines)
Delivered by the licensor.
Available in the literature or from the developer.
Development of derivatives: new translations, electronic implementation, publications
The licensor shares specific guidelines obtained from the COA developer with users.
Usually, there are no specific guidelines, but this must be confirmed through due diligence.
Modifications: changes made by the user to the content and/or layout of the COA
Need to be approved by the licensor on behalf of the developer to ensure the integrity of the COA and its measurement properties are not altered.
Usually, no need to receive approval from the developer.
However, users must be aware that modifications can impact the validity of the measurement properties of the COA.
If changes should be made to a clinical trial protocol after the licensing agreement has been signed which impact the COA’s scope of use (e.g., an additional country, higher number of patients), then the licensor should be informed immediately and issue amendments accordingly. These changes would likely incur additional licensing and service fees.
How can Mapi Research Trust help with copyright considerations and licensing of COAs?
- Access our online platform ePROVIDETM (5,900+ COAs documented) and submit your request.
- Visit our catalog of 700+ COAs exclusively distributed by Mapi Research Trust.
- Read our Blog “How to successfully prepare the licensing of Clinical Outcome Assessments”.