Introduction

Clinical trials are essential for determining the safety and efficacy of new drugs or medical devices. These trials also produce a significant volume of documentation that must then be translated into various languages. Given the stringent safety and regulatory requirements in this field, accurate and high-quality translations are critical. What are some of the challenges that clinical research organizations face when translating clinical trial documents? How can these organizations and other stakeholders get the best possible translation results? In this blog post, we’ll look at some of the typical documents used in clinical trials that need to be translated, challenges during the translation process, the five keys to successful clinical trial document translation, and how to select the right translation provider.

What are some of the most common clinical trial documents?

There are many different types of documents associated with clinical trials, and because of the international nature of most trials, many of these documents need to be translated. Although there are different types of clinical trials, some of the most commonly required documents include:

 

• Trial protocols: These documents outline the objectives, methodology, and organization of the clinical trial. Protocols provide an important framework for conducting the trial.
• Informed consent forms (ICF): Study participants must give their consent to participate in the clinical trial, and this consent must be based on all of the relevant information. ICFs should be written in plain language to ensure they are understood by all trial participants.
• Study monitoring plan: These plans ensure that the trial adheres to all regulatory requirements and ethical guidelines.
• Adverse event reporting: Prompt and accurate reporting of adverse events is crucial for patient safety and trial integrity.
• Case report forms (CRFs): CRFs meticulously document patient data throughout the trial, providing vital information for analysis.
• Patient-reported outcomes (PROs): Patient-reported outcomes (PROs) are records kept by the patients themselves, covering aspects like symptoms, care satisfaction, and overall well-being. PROs can provide important information about side effects and aid in tailoring optimal care plans.

 

The one feature that all of these documents have in common is their complex medical and technical nature, which can present hurdles during the translation process.

Challenges of clinical trial translations

Translating clinical trial documentation poses a unique set of challenges beyond those encountered in typical translation projects. Here are some of the key challenges:

 

• Complex terminology: Clinical trials involve a wide range of specialized technical and medical terms that must be translated accurately and consistently.
• Volume: The sheer volume of documents associated with a clinical trial can be overwhelming, requiring efficient translation and project management processes and workflows.
• Cultural sensitivity: The human element is paramount in clinical trials. Translators must be attuned to cultural nuances to ensure the translated documents resonate with participants and accurately convey essential information.

The five steps to high-quality clinical trial translations

Above all, translations of clinical trial documentation must be accurate. Even minor errors can have a significant impact on patient safety, regulatory compliance, and the overall validity of the trial. Here are five key quality control aspects to ensure the best possible translation of clinical trial documentation:

 

• Work with qualified translators who have experience with medical and clinical translation to ensure the best results. This is not a subject area where a translator can learn on the fly.
• Use terminology management tools to ensure the consistency and accuracy of technical terms. Wrong or inconsistent technical terms can result in confusion or safety issues.
• Implement a rigorous quality control process with two or three translators translating, editing and, where appropriate, proofreading the translations.
• Manage large volumes while maintaining quality and meeting deadlines. Because of the large amount of documents that clinical trials produce, it is best to work with a translation partner with offices in multiple time zones to ensure quick responses and, where necessary rolling deliveries.
• Stay attuned to the cultural nuances of the translated documents. Translation is more than the mere transfer of words. They must also be culturally appropriate to ensure the highest level of comprehension among study participants.

 

In addition, a certificate of accuracy will provide further evidence of the accuracy and quality of the translation. Such certificates should generally be provided free of charge.

Finding and working with a translation partner

Because of the complex nature of clinical trial documents, it is essential to work with a translation partner with proven expertise in this domain. The ideal partner should have the following qualifications:

 

• Extensive experience translating clinical trial documents and life sciences materials.
• A deep understanding of medical terminology and the relevant regulatory requirements.
• A team of native-speaking translators with expertise in the target languages and cultural backgrounds of the trial participants.
• Rigorous quality control processes, including a multi-step review and terminology verification.

 

Because of the highly sensitive and complex nature of clinical trial documents, quality control is paramount. Following these steps will help maintain the integrity of the translation process and ensure the highest-quality translation results.

Conclusion

Working with an experienced translation partner is essential when translating clinical trial documentation. A suitable translation provider will know how to tackle terminology, have substantial experience working with the relevant documents, and have an understanding of the target culture to ensure the most appropriate translations. They should also have rigorous quality control processes to reduce the risk of errors to as close to zero as possible.

 

Contact GLS to see how we can help you with your clinical trial document translations. We have more than 40 years of experience working with some of the biggest names in the pharmaceutical and healthcare industries to provide the highest level of quality, accuracy, confidentiality.

 

By Jim Cohen