Anyone who needs a translation will likely need a back translation at one point or another. This is generally true for anyone involved in life sciences, including members of contract research organisations (CROs), clinical teams and sponsors of drug trials. Regulations are especially strict when it comes to pharmaceuticals and clinical trials. As such, Ethics Committees (ECs) and Institutional Review Board (IRBs) often require back translations as part of the Trial Master File.
But back translation is more than just a regulatory or legal requirement. It can also be used as an additional quality control tool for translations in industries where critical information is published in multiple languages. For example, legal teams use back translation to ensure conceptual equivalence and avoid any potential inconsistencies between the two languages used in the contract. Manufacturers distributing medical devices worldwide will also have IFUs back translated to make certain that the instructions are consistent with the original, eliminating potential errors.
What exactly is a back translation?
Back translation is the second step of the translation process, the first being a forward translation. While a forward translation converts the source text into the target language, the back translation converts the translated text back into the source language. So for example, if a text is translated from English into Spanish, a back translation converts the Spanish text back into English.
This back translation is carried out by an independent translator with no knowledge of the original text. The purpose of this is to compare the back translation with the original document to find any inconsistencies. If none are found, the translation is considered equivalent and accurate. Otherwise, any discrepancies between the back translation and the source text help identify issues that can then be addressed. The result is an extremely high-quality translation.
When is back translation used?
As shown above, there are two major reasons why you might request a back translation:
- To comply with legal and regulatory requirements
- To check the quality and accuracy of the translation and ensure there are no errors, which could have devastating consequences for businesses
When it comes to clinical trials, the rules and guidelines are especially strict. Both the EMA’s Guideline for Good Clinical Practice E6(R2) and the FDA’s Code of Federal Regulations 50.20, subpart B, stipulate that any written information about the trial, including informed consent forms, should be clearly understandable to the subject. They also state that IRBs and ECs should require all documents to be translated and ensure that these translations are accurate.
There is no mention of how IRBs and ECs should go about ensuring the accuracy of the translations. However, most will demand that protocols, investigator’s brochure, consent forms and all other clinical trial documents be translated by a qualified translator. They can either be a certified translator, or they can provide documentation certifying that the translation is consistent with the approved documents. They then suggest using back translation as an additional quality assurance step, which allows you to produce documents of the highest quality in all languages.
The new Medical Device Regulation also requires distributors and importers to have “in place a quality management system that includes procedures which ensure that the translation of information is accurate and up-to-date”. This information needs to be translated into all languages of the Member State where the product is to be sold. In this case, many will use back translation to ensure consistency across every language and make certain their documents comply with these regulations.
Regardless of why you might use a back translation, this additional translation process will help ensure the quality of your translation. This will ultimately streamline your project, helping move it towards success and avoiding any delays to market or negative legal consequences.