NOVIMEDGROUP — LINGUISTIC VALIDATION PROJECT BRIEF
Version 1.0 | 5 October 2026
https://www.novimedgroup.com/linguistic-validation

A reusable planning worksheet for an initial COA/eCOA project discussion.
This is an editorial planning aid, not an approved validation protocol.
Adapt it with the instrument owner and the responsible project specialists.
Do not include patient-identifiable or confidential study data in a public copy.

1. INSTRUMENT AND PERMISSIONS
Instrument name, version and intended construct:
Instrument owner and permission/contact reference:
Existing approved translations and permitted adaptations:
Person responsible for resolving licensing questions:

2. POPULATION AND CONTEXT
Target population and intended setting:
Respondent type (patient, caregiver, clinician or observer):
Literacy, accessibility and age-related considerations:
Concept definitions, recall periods and response scales to preserve:

3. LANGUAGE AND LOCALE PLAN
Source language and country:
Target language-country pairs (one pair per line):
Existing language versions and the evidence supporting reuse:
Country-specific terminology or cultural questions to resolve:

4. SOURCE READINESS
Approved source file identifier and date:
Ambiguous wording or unresolved queries:
Instructions, help text and interface strings included in scope:
Change owner and agreed source-freeze process:

5. AGREED METHODOLOGY
Required translation, reconciliation and review stages:
Back-translation and harmonization requirements, where applicable:
Instrument-owner review and approval points:
Cognitive-debriefing approach and recruitment responsibilities:
Consent, privacy and ethics requirements to confirm:
Do not select a universal participant count without considering the protocol.

6. ELECTRONIC IMPLEMENTATION
Platform, devices and modes of administration:
Approved wording-to-build version mapping:
Screens, line wrapping, response controls, branching and accessibility checks:
Who reviews screenshots and the working implementation:
Issue severity, resolution evidence and retest responsibilities:

7. EVIDENCE AND DELIVERY
Required translation history, query log and decision rationale:
Interview findings and resulting change records:
Final approved version, approval owner and delivery format:
Secure exchange channel, retention and access arrangements:
Acceptance criteria and unresolved items at handover:

8. SCHEDULE AND CHANGE CONTROL
Milestones and review turnaround assumptions:
Dependencies (permissions, recruitment, source freeze, platform builds):
Procedure when the source or instrument version changes:
Project contacts and decision owners:

READ FURTHER
Planning guide:
https://www.novimedgroup.com/resources/blog/coa-linguistic-validation-process
Cognitive debriefing:
https://www.novimedgroup.com/resources/blog/cognitive-debriefing-patient-interviews
eCOA implementation review:
https://www.novimedgroup.com/resources/blog/ecoa-translation-migration-review

You may copy and adapt this worksheet for project planning. If sharing the
blank worksheet publicly, credit NovimedGroup and link to the planning guide.