Helping developers and copyright holders provide timely, accurate support

Providing responsive and practical support to licensees is one of the most effective ways to protect the scientific integrity of a Clinical Outcome Assessment (COA). When licensees encounter barriers, delays, or uncertainty, they may unintentionally introduce modifications, develop alternative versions, implement the instrument incorrectly or even remove the COA from their protocol. Efficient support helps ensure that COAs are used as intended while maintaining validity, reliability, and regulatory acceptability.

This document explains why licensee support matters, how modifications can affect validity, and how developers, copyright holders, Mapi Research Trust (MRT), and licensees can work together to achieve successful outcomes. MRT is committed to supporting developers and copyright holders throughout this process, acting as a collaborative partner to help address licensees’ needs while safeguarding the scientific integrity and validity of the instrument.

Providing timely support to licensees creates value for everyone involved. It helps:

✅ Preserve scientific validity

✅ Protect copyright and authorship

✅ Reduce the risk of inappropriate modifications

✅ Increase consistency across studies and settings

✅ Support regulatory expectations

✅ Improve the visibility and adoption of the instrument

Licensees are often operating under tight study timelines. We therefore highly recommend providing an initial response within five business days, even if additional time is needed to review the request fully. When guidance is unavailable or delayed, licensees may make independent decisions that can ultimately compromise the integrity of the measure or discourage its use. Proactive support helps prevent problems before they occur.

A delayed response can have consequences that extend well beyond a single inquiry.

Potential impacts include:

• Study start-up delays
• Delays in licensing and implementation
• Duplicate translation efforts
• Incorrect scoring approaches
• Development of unauthorized derivatives
• Increased regulatory questions
• Modification requests by regulatory authorities
• Additional costs for sponsors and researchers
• Removal of the COA from the study protocol and selection of an alternative instrument

In many cases, early feedback from the copyright holder can prevent weeks or months of corrective work.

Many licensees assume that small adjustments do not affect a COA's validity. In reality, even seemingly minor changes may alter what the instrument measures. Changing wording, response options, translations, or electronic versions can affect the integrity of the instrument and does require permission from the copyright holder.

Examples of modifications that may affect the scientific integrity of a COA include, but are not limited to:

❌ Rewording items to "simplify" language

❌ Altering response scales

❌ Altering the recall period

❌ Removing or adding instructions

❌ Shortening the questionnaire

❌ Combining items

❌ Creating new electronic versions without appropriate review

These changes may affect:

• Content validity
• Measurement equivalence
• Comparability of study results
• Regulatory acceptability
• Published evidence supporting the instrument

Mapi Research Trust serves as a bridge between developers/copyright holders, and licensees. We reduce the administrative and operational burden on developers and copyright holders while ensuring that inquiries and requests are managed consistently and efficiently.

Key support activities include:

• Obtaining approval from copyright holders in case of modification request
• Responding to licensees’ inquiries, including questions related to conditions of use, available language versions, scoring and interpretation.
• Managing licensing activities, including the review and processing of license requests, along with licensing agreement execution.
• Distributing existing language versions.
• Coordinating requests for new translation development and overseeing the associated processes.
• Supporting electronic migration projects to help ensure the faithful implementation of COAs in digital formats.
• Facilitating the development and distribution of eBooklets.
• Providing access to scientific scoring expertise through MRT's specialized scoring team when required.

As a developer or copyright holder, your support helps:

✅ Facilitate the appropriate use of your COA.

✅ Keep studies on track by providing timely guidance on proposed modifications.

✅ Protect scientific integrity by ensuring that changes are reviewed before they are implemented.

✅ Reduce delays and additional costs by addressing questions early, before they become larger operational or scientific issues.

✅ Promote consistency across studies by providing licensees with clear, authoritative guidance.

✅ Enhance the reputation and long-term value of the instrument through positive licensee experiences and successful implementations.

✅ Build stronger partnerships with licensees by acting as a trusted scientific advisor.

Supporting licensees is one of the most effective ways to protect a COA. Timely collaboration helps studies stay on track, prevents inappropriate modifications, and ensures that scientific integrity is maintained for the benefit of all stakeholders.

Protecting a COA goes beyond managing intellectual property and access rights. It also means ensuring the instrument is used as intended to generate reliable, meaningful, and comparable data across studies and populations.

Developers, copyright holders, MRT, and licensees share a common goal: generating high-quality evidence. Through collaboration, timely communication, and practical guidance, they can reduce implementation challenges, protect validity, and support successful research outcomes.

Ultimately, supporting licensees is an investment in the long-term integrity, credibility, and impact of the instrument. By working together, stakeholders can enable efficient study execution while safeguarding the quality and reputation of the COA.