The critical role of back translation in COAs
08 Aug 2023
4 mins
Accurate translations of Clinical Outcome Assessments (COAs) are imperative in the life sciences industry to maintain data integrity, regulatory compliance, and patient safety. In this blog post, we will delve into the significance of accuracy in COA translations and shed light on the critical role of back translation. We will also explore a real-world example in French and Spanish to highlight the importance of precise translations in COAs.
The importance of accuracy in COA translations
COAs provide essential information about product composition, quality, and safety, making them indispensable in the life sciences industry. Accurate translations are crucial for clear communication and understanding across different languages and markets. Inaccurate translations can lead to misinterpretation, regulatory issues, compromised patient safety, and reputational damage. Therefore, precision in COA translations is of paramount importance.
So where does back translation come in?
Back translation serves as a robust quality assurance process in COA translations. It involves the dual translation of the target language back into the source language to validate the accuracy and meaning of the initial translation. This step acts as a valuable checkpoint to ensure that the translated COA faithfully reflects the information provided in the original document. It helps with:
- Identifying Errors and Ambiguities: Back translation reveals potential errors, ambiguities, or misinterpretations that may have occurred during the initial translation process. Discrepancies can be detected by comparing the back-translated version with the source language, allowing for necessary corrections and ensuring precise communication.
- Maintaining Data Integrity and Consistency: Back translation helps preserve data integrity by ensuring that the translated COAs maintain the same level of accuracy and meaning as the original documents. This consistency across languages is crucial in delivering reliable information to stakeholders.
- Enhancing Regulatory Compliance: Accurate translations of COAs are essential for regulatory compliance. Back translation ensures that the translated COAs adhere to regulatory requirements, preventing misunderstandings and non-compliance that could result in costly delays or legal implications.
What kind of errors does back translation avoid?
An illuminating example that underscores the importance of accurate translations is the French word "sensible." In English, "sensible" often means "practical" or "reasonable." However, when translated to French, the term "sensible" can be misleading. In the context of COAs, "sensible" in French can refer to "sensitive" or "responsive," which conveys an entirely different meaning. This nuance emphasizes the critical role of accurate translations in maintaining the intended information and avoiding confusion or misinterpretation.
Another example that highlights the importance of accurate translations is the term "dosage." In English, "dosage" commonly denotes the prescribed amount of medication. However, the term "dosage" can be misconstrued as referring to the "dosage form" when translated into other languages.. In Mexican Spanish, for example, this in fact pertains to the physical presentation of the medication (e.g., tablet, capsule, liquid). This nuanced distinction underlines the critical role of precise translations in conveying the intended information, preventing confusion, and minimizing the risk of medication errors.
The back translation process
Subject matter experts (SMEs) with native-level proficiency in both the target and source languages are engaged to execute back translation effectively . These experts possess deep domain knowledge and expertise in the specific terminology and regulatory guidelines associated with COAs. Leveraging their linguistic skills and industry understanding, SMEs ensure accurate back translation, mitigating the risk of misinterpretation or inaccuracies.
Accurate translations of COAs are vital for maintaining data integrity, complying with regulations, and safeguarding patient safety in the life sciences industry. Back translation plays a crucial role as a quality assurance step, enabling companies to validate the accuracy and meaning of translated COAs. Partnering with language service providers like RWS that offer back translation services and employ subject matter experts ensures precise translations, reduces risks, and upholds the highest standards of quality and compliance in COAs. Diligent attention to translation accuracy fosters trust, ensures reliable information exchange, and contributes to improved patient outcomes in the life sciences industry.
At RWS, we understand the importance of a well-executed linguistic validation process and have the expertise and experience necessary to guide you through it. Our end-to-end process management, eCOA solutions team, and extensive linguistic validation experience ensure that your translations are done right. Contact us to learn more about how our team can help you navigate the complexities of linguistic validation and achieve success in your clinical trials. We are always ready to work with you to ensure that your clinical trial runs smoothly and successfully.
Dan Herron
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