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COA Pre-Publication Checklist: Key points to check before release
Publishing information on your Clinical Outcome Assessment (COA), especially in peer-reviewed journals, is more than a scientific achievement - it is a critical moment where every decision shapes copyright ownership, control of access, version management, and the long-term integrity of your work.
At this pivotal stage, every decision matters.
With its recognized expertise, Mapi Research Trust supports developers through this complex process, helping safeguard intellectual property, maintain control, and maximize the value of your COA assets.
Drawing on two authoritative sources - the ISOQOL TCA‑SIG Reflection Paper on PRO copyright and the 2024 Mapi Research Trust Whitepaper on copyright risks, this checklist summarizes the critical steps every developer should take to protect their instrument and avoid unintended consequences.
Use this checklist to safeguard your work.
ESSENTIAL CHECKS BEFORE TAKING YOUR WORK TO PUBLICATION | |
1. Confirm Copyright Ownership Before You Publish Before submitting an article, confirm: | |
¨ | Who currently owns the copyright (developer, co‑developers, sponsor, employer, etc.). |
¨ | Whether past agreements (employment, funding, collaboration) have assigned rights elsewhere. |
¨ | Whether translations or digital versions have additional copyright holders involved. |
¨ | Whether agreements exist around derivative works (translations, e‑versions). |
⚠ | If you are not the copyright owner, it is essential to obtain formal authorization before publishing any information related to the COA. Please note that the COA itself must not be included within the publication. |
2. Avoid Publishing the Full Instrument in the Journal | |
¨ | Do not publish the questionnaire in full in the article. |
¨ | If you must publish the questionnaire:
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3. Understand What Rights a Publisher May Acquire | |
¨ | Most journals require developers to sign copyright transfer agreements. Seek legal advice to review these, to ensure that there is no transfer of instrument rights to the journal. |
¨ | If the journal offers a Creative Commons license, please refer to the following website to review the applicable terms and conditions: https://creativecommons.org/cc-licenses/. |
¨ | If publication of a full instrument is unavoidable, ensure the publication contract explicitly states that copyright remains with the original copyright owner. |
4. Register Copyright Where Possible | |
¨ | Although copyright often exists automatically upon creation, formal registration provides stronger legal protection. |
¨ | Seek advice from qualified legal counsel or an intellectual property attorney regarding the appropriate procedures and requirements for registering copyright. |
¨ | Consider registering the questionnaire/items, scoring manuals, user guides, electronic formats, etc. |
Disclaimer: This checklist is provided for general informational purposes only and reflects suggested practices. It does not constitute legal advice and should not be relied upon as such. Consult qualified legal counsel or an intellectual property attorney for advice tailored to your specific situation, particularly in cases of uncertainty.
For more information on safeguarding your instrument prior to publication, or for support in the process, please reach out to our experts.
1. Anfray C, Arnold B, Martin M, Eremenco S, Patrick DL, Conway K, Acquadro C; ISOQOL Translation and Cultural Special Interest Group (TCA-SIG). Reflection paper on copyright, patient-reported outcome instruments and their translations. Health Qual Life Outcomes. 2018 Dec 5;16(1):224. doi: 10.1186/s12955-018-1050-4. PMID: 30518380; PMCID: PMC6282242.
2. Mapi Research Trust (2024). Clinical Outcome Assessments (COAs) and copyright: How to mitigate risks of infringement and misuse in clinical research and practice.