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Local packages for a multinational trial do not always need to be identical. Country-specific attachments and language needs may differ. The underlying scientific account of the same protocol should not contradict itself, however. Sponsors should distinguish legitimate localisation from an unintended change in the activities being described.
Decision framework
Identify shared scientific sources and country-specific document types first. Assess whether a local change concerns format or process, or affects an activity performed at a site. If local interpretation requires changing scientific source content, use the appropriate expert and regulatory decision route rather than concealing the issue as an ordinary translation correction.
Worked example
For example, shortening a visit description in one country's package changes the apparent timing of sample collection. The team examines the activity against its source rather than checking terminology alone. It corrects the document or initiates the relevant process if a real change is intended. Other packages are sampled for similar shifts in meaning.
Implementation checks
- Link the common source version clearly to the relevant scientific documents within each country's submission package.
- Record local differences with their rationale, classifying formatting adaptations separately from changes that affect substantive trial content.
- When a meaning-changing difference is found, define who will review the other packages that may also be affected.
Acceptance and boundaries
Accept review when local requirements are preserved and teams explain the core trial activities consistently. This example does not describe every legal requirement for national dossiers. Country expertise remains necessary, and a comment received in one setting should not automatically be assumed to apply across all participating countries.
Frequently asked questions
- Should every country use the same file?
- No. Local differences may be needed, while consistency of scientific meaning still requires assessment.
- Is every difference an error?
- No. Distinguish justified localisation from unintended substantive change.