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The Mapi Research Institute methodology is the gold standard for validation for clinical trial translation. The Mapi workflow is designed to leave no stone unturned, as each version of the translation is carefully groomed for the intended audience.

Surveys and questionnaires pose a lot of problems for translators and issues of cross-cultural balance and understanding can be of crucial importance to the success of the translation. That's why a highly-skilled team is required to properly implement this complex workflow, and there are few with the required talent. It is a great workflow though. “Many eyes keep danger at bay,” as I am wont to say. However, gold standards generally require a lot of gold. No wonder then, that the group recommending this as a best practice also sells the same service. For many organizations and budgets, this kind of standard is unrealistic.

We’ve identified twelve distinct translation steps in the Mapi model:

1. Concepts defined: The source-language document is investigated so that each item in the source can be accurately reflected in the translation. Concepts investigated by each item of the source language are analyzed to ensure they are reflected appropriately in the target languages. The source document is analyzed and concepts defined for each questionnaire item to facilitate accurate translation of concepts before translation even begins.
2. Two forward translations are completed by two independent translators.
3. The two translators and the project manager reconcile the two translations to arrive at a “consensus” version.
4. Quality control review for any additional modifications.
5. Back translation into English by a third independent translator for further assessment and quality control. Source and back translations are checked to ensure conceptual integrity. Additional modifications as required.
6. Pilot testing cognitive debriefing provides input from people representing future users of the questionnaire to assess the clarity, intelligibility, appropriateness and cultural relevance of the target language version to the target population.
7. Pilot testing clinician’s review to get input from medical experts on the translation as to the domain-specific terminology of the instrument.
8. Pilot testing harmonization: additional inputs are incorporated into a third target language version.
9. Balance analysis (required only when translating into multiple languages): this analysis compares each translation to ensure that concepts are consistently expressed in all languages and to make any changes to enhance cross-cultural correspondence. Suggested changes are then submitted to language-specific contributors for approval of translation version 4.
10. Proofreading round 1.
11. Proofreading round 2.
12. Findings report issued on delivery of final.

In many cases, all these steps are not necessary and may not even offer the best communications outcome. When there are a lot of cooks in this kitchen, each level of correction introduces an additional potential for error. Is review of this standard causing your institutional review board to throw up its hands in despair for developing an effective, cost-effective translation validation method? It does not have to be that way.

To discuss your validation requirements for clinical trial translation, please contact us at 1-800-872-6752 (+1-212-818-1102 outside the US) or [email protected].