Skip to main content
Home
  • Clinical Outcome Assessments
    Clinical Outcome Assessments

    What are Clinical Outcome Assessments (COAs)? What do they measure?

    Learn more about COAs
    hero_1.jpeg
    The most trusted distributor of COAs

    700+ exclusive COA distributions on behalf of their copyright owners

    hero_2.jpeg
    PROQOLID™: the largest COA database

    7,000+ COAs described in details and accessible in this unique database

  • Services
    Services

    Mapi Research Trust provides turnkey solutions for your Clinical Outcome Assessments (COAs) strategies - including COA databases, targeted literature reviews, licensing.

    Read More
    COA Databases Patient-Centered Endpoint Intelligence COA Licensing Translation and Linguistic Validation eCOA Licensing COA Repository
    hero_3.jpeg
    About ePROVIDE™

    Online access to all our services and COA databases

    hero_2_2.jpeg
    What are eBooklets?

    Find out more about this step-by-step guidance for valid digitization of COAs

  • Author Collaboration
    Author Collaboration

    Our team is dedicated to assisting authors in the daily management of their questionnaires and all derivatives, including translations and electronic versions

    Read More
    COA distribution COA copyright and protection Promotion of COAs and developers Testimonials
    hero_3_1.jpeg
    Catalog of COAs distributed by Mapi Research Trust

    800+ exclusive distributions of COAs, accessible in ePROVIDE

  • Resources
    Resources

    ACCESS all our resources on COAs and eCOA: webinars, publications, blogs. SUBSCRIBE to receive email updates.

    Read More
    Blog Publications Useful links Webinar recordings Whitepapers
    Whitepaper-Digitizing-COAs.jpg
    New whitepaper

    Digitizing COAs: A streamlined approach to approval

    hero_4_2.jpeg
    New whitepaper

    COAs and copyright: How to mitigate risks of infringement and misuse in clinical research and practice

  • News & Events
    News & Events

    Stay informed with our latest news and check all our upcoming events. SUBSCRIBE to get email updates.

    Read More
    hero_5_1.jpeg
    News
    Hero_5_2.jpeg
    Conferences
    Hero_5_3.jpeg
    Webinars
  • About us
    About us

    Mapi Research Trust is a non-profit organization dedicated to improving patients’ quality of life by facilitating access to Clinical Outcome Assessments(COAs).

    Read More
    hero_6_1.jpeg
    Team

    A global team of multi-disciplinary experts

    hero_6_2.jpeg
    Experience

    Collecting & Processing Patient Centered Outcomes information for more than two decades

  • Contact
  1. Home
  2. Resources
  3. Blog
  4. Clinical Outcome Assessments' copyright

Clinical Outcome Assessments' copyright: impacts on clinical trials and how to obtain permission for use

  • 12 July 2023

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”.
In this section
In this section
  • Blog
  • Publications
    • PROQOLID
    • PROLABELS
    • Literature Review
    • Intellectual Property, copyright issues, and distribution of Patient-Centered Outcomes
    • Translation & Linguistic validation
    • Therapeutic areas
      • Digestive health, gastroenterology, metabolism
      • Endocrinology
      • General
      • Gynecology
      • Hematology
      • Infectious disease, immunology, vaccines
      • Ophthalmology
      • Pain
      • Psychiatry-psychology
      • Rare Diseases
      • Respiratory
      • Rheumatology–musculoskeletal disorders
      • Urology
    • Cochrane HRQoL Methods Group
    • Development projects
    • Education
    • ERIQA/PRO harmonization
    • IQOD
  • Useful links
  • Webinar recordings
  • Whitepapers
    • Whitepaper | COAs and copyright
    • The COA licensing process: How to prepare for success
    • Whitepaper | Digitizing COAs: A streamlined approach to approval

Related information

Blog

Licensing of COAs, best practices

Webpage

End-to-end services in the field of COAs

Site Branding
    ICON plc
  • Contact
  • About Us
For Clients
  • Services
  • Resources
  • ePROVIDE™
News & Events
  • News
  • Conferences
  • Webinars
Socials
  • Linkedin

Legal Footer

  • © 2025 Mapi Research Trust
  • Disclaimer
  • Privacy
How can we help?
  • All
Popular search terms:
  • COVID-19
  • Site & Patient Recruitment
  • Oncology
  • Medical Device
  • Real World Evidence
  • Decentralised & hybrid clinical trials
  • Digital Disruption