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Quality Assurance in Clinical Trial Translation

Good translation starts with good translators, naturally, but the devil is in the validation. Proper quality assurance methodology is what separates professional translation from an amateur effort, especially when it comes to clinical trial translation.

Ensuring a good translation outcome for trial participants is best accomplished as it is for other demanding audiences. The ABCs of professional translation project management, where quality control and efficient workflow go hand in hand, are as suitable for Institutional Review Boards (IRBs) as other quality intensive clients, where accuracy and confidentiality are paramount. This ISO-compliant process generally consists of six or seven steps:

1. Intake with development of glossary, translation memory, style guide and letter of engagement defining the project. Any conceptual or cross-cultural balance issues for multilingual projects can be incorporated into the style guide.

2. Translation by an experienced industry specialist who is qualified before engagement and evaluated after.

3. Edited by an experienced and knowledgeable editor who is qualified and evaluated.

4. Third-party edit and analysis produce a findings document proof; then, review by a trained validation team, which can include a language manager, clinicians and/or end users. This step is often omitted.

5. Harmonization of the consensus document and proof for submission to the validation team.

6. Review by the validation team, which may include bilingual staff, clinicians and end users trained in the basics of translation validation. Clients who do not have the resources to validate on their own may outsource this process.

7. Harmonization of the translation/validation final, proof and delivery.

In addition to the usual certifications of accuracy, QA workflow can be certified and documented via ISO accreditation or other applicable certification process. Due diligence ensures a defensible process and the safety and knowledgeable consent of clinical trial participants.

The key elements to success for clinical trial translation quality assurance, or of any translation quality assurance process, is that standardized and measurable processes are used to qualify and evaluate team member skills and performance, and that feedback at every stage of the process identifies, corrects and prevents error in a documented process of continual improvement.

This far more efficient process will produce comparable results at a fraction of the time and cost of the MAPI institute methodology and is far superior to much of the translation now supervised by IRBs.

To discuss your requirements for clinical trial translation quality assurance, please contact us at 1-800-872-6752 (+1-212-355-4455 outside the US) or

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