Resources
Practical guidance and industry resources to support early COA planning, licensing, translation availability assessment, gap analysis and coordination across clinical studies.
Guide
Selecting an appropriate Clinical Outcome Assessment (COA) is only the beginning. Before an instrument can be used, translated, adapted or implemented electronically, study teams need to confirm the correct instrument and version, who controls the rights, which permissions apply and whether approved translations are already available.
Our practical guide covers early licensing planning, instrument and version identification, copyright and licensing considerations, existing and new language versions, electronic-use permissions, licensing scope, ongoing COA management and common licensing risks. It also explains how licensing connects with Linguistic Validation and eCOA implementation throughout the study lifecycle.
Industry
Access FDA resources concerning Clinical Outcome Assessments and patient-focused drug development, including considerations relevant to the selection, development and use of COAs in clinical trials.
Explore FDA COA Resources →
Explore EMA guidance and scientific resources relevant to the use of patient-reported and other clinical outcome measures in medicinal product development.
Explore EMA Resources →
Explore collaborative resources and initiatives relating to COA development, qualification, patient-focused drug development and the use of outcome measures in clinical research.
Explore C-Path Resources →
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