Clinical Outcome Assessment Translation Requirements

DocumentTranslationsAudience: COA Measure Owner/Developer, eCOA Provider, Language Service Providers, Sponsor

Overview

This resource provides a framework for gathering, documenting, and communicating the requirements related to the translation of clinical outcome assessments, specifically in support of electronic implementation workflows, and will guide the documentation of measure licensing and review requirements, and facilitate efficient coordination between all stakeholders. 

Key Details

RESOURCE TYPE Requirements Document, Template
PRIMARY USE Capturing and standardizing COA translation, linguistic validation, and eCOA implementation requirements across stakeholders and studies.
RELEVANT WORKFLOW AREAS Study Start Up, Requirements
RELATED TAGS Linguistic Validation, Requirements, Translations