A collaboration between Critical Path Institute’s eCOA Consortium and PCE Consortium, and the International Society for Quality of Life Research (ISOQOL) with the goal of creating resources that reduce friction in processes related to the translation and licensing of COA measures. At the time of launch in August 2026, the TLM project was comprised of 11 subteams and led to the creation of over 15 resources.

The TLM authors are comprised of eCOA Consortium and PCE Consortium members representing 17 member organizations including pharmaceutical sponsors, CROs, eCOA, translation, COA licensing and sensor/medical device providers. As industry members whose daily work involves the translation and licensing of COA measures, they are our experts at identifying best practice guidance and to advise readers regarding the paths of least friction.

The translation and licensing of COAs can be complex in the context of a clinical trial. Translations requirements, coyright holder/owner expectations, license agreements, and permissions for reuse vary by vendor company and measure owner. When planning for the translation and licensing of a measure, all industry members seek to keep these tasks off of the trial’s critical path. And yet in practice, surprises and delay remain common.

Yes. These documents undergo a robust review process that includes all the members in the eCOA Consortium Coordinating Committee, PCE Consortium eCOA Subcommittee, PCE Consortium Coordinating Committee, and C-Path team. Over 150 individuals across member firms are given the opportunity to review and provide feedback on every single document. After the review cycle is complete, each document then undergoes an approval cycle by the eCOA Leadership Team and final clearance by senior members of the C-Path team.

We would like to thank the following teams for their dedication to this process:

TLM Leadership Team: Kate Zarzar, Piero Bindi, and Teresa Williams

Peer Review Team: Simone Kina, Foteini Sakellaropoulou, Hayley Simpson-Finch, Louise Simpson-Jones, and Dagmara Kulis

Sub-Team Leaders: Caroline Anfray, David Churchman, Denise D’Alessio, Kayla Doyle, Stacey Higgins, Marina Kec, Vanitha Krishna, Dagmara Kulis, Elsa Lindstrom, Shawn McKown, Emily Parks-Vernizzi

COA Measure Owner/Developer

An individual or entity who owns, creates, or adapts a COA measure. (eCOA Lexicon v4.0)

Language Service Provider

A company that offers professional translation, interpreting, and localization services.

Sponsor

In the conduct of a clinical study, a sponsor is an individual, company, institution, or organization that takes responsibility for initiation, management, and/or financing of a clinical trial, but may not actually conduct the investigation. (eCOA Lexicon v4.0)

eCOA Provider

A company that provides electronic data capture technologies and services that support the collection of patient-focused outcomes data in clinical trials.

Each document has a unique lifecycle based on the content and contributor availability. When also factoring in the month long review and approval process, documents can take anywhere from four months to twelve months to develop and publish.

Yes; more info to come soon.