Updating Clinical Study Documentation: Translation, Consistency and Quality

Using the most of the translation process

Once the basic aspects of a translation process have been defined (scope, deadline, language pairs, etc.), it is crucial to assemble the best project team on the basis of linguistic and subject-matter expertise.

This essentially means assigning the linguists with both linguistic proficiency and deep understanding of clinical research procedures (both in general and on the target market/country) to the project. They need to understand the type, structure and purpose of any document that may be required in the course of clinical trial, as well as the specific medical, legal and (in certain cases) technical terminology used by the clinical research organizations and regulatory authorities on the target market.

Once the translation is finished and approved by all stakeholders (including the local regulatory bodies), the translated versions can be used for creation of translation assets.

Translation assets and benefits of their use

Translation assets include translation memories (segmented databases containing previously translated and approved elements in a specific language pair), termbases (databases containing translations of preferred terms in a specific language pair) and sometimes glossaries (monolingual definitions of specific terms and procedures).

The previously translated elements are the building blocks of translation assets and their benefits include:

• Lexical and stylistic consistency – every new translation is performed to match the previously used and approved style and terminology. Specific terms such as medical and pharmaceutical terminology, medical titles, names of CROs and other institutions are used consistently.
• Quality control – use of translation assets represents an additional layer of real-time quality control because linguists are able to perform their tasks on the basis of previously translated materials.
• Easy updates – any change in the source material can be easily and automatically implemented in the translated materials.
• Cost/time optimization – use of translation assets enables long-term saving of the time and resources required for translation.

Managing translation assets

Termbases can be multilingual, while translation memories are created for a specific language pair. It is, however, possible to develop several translation assets that can be used for different purposes within one account.

For example, it is possible to create separate translation memories for the materials composed by the healthcare professionals for other healthcare professionals (Investigator’s brochures, protocols and amendments, Case Report Files (CRF), various tests, instructions, reports, approvals, authorizations, etc.), the materials given to the subjects (Informed Consent Forms (ICF), advertising materials, all subject-oriented textual materials) and various legal and financial documents (agreements, insurance statements, financial documentation, etc.) and to use them for further translation of these materials accordingly in conjunction with one master termbase.

The various specific of different types of documents oriented to different stakeholders and designed for different purposes within a clinical research will thus remain consistently and appropriately translated, ultimately also optimizing the expenses and the required time of translation.

Of course, it is also possible to develop and use only one master translation memory.

Wrap-up

With the right process in place and with smart application of language technology, it is possible to address the challenges of translation in clinical research, retain consistency and quality of different types of materials, easily update the translated files and ultimately cut the translation costs.

If you want to learn more about the language technology and its use, check out our feature article How to Cut Localization Costs with Translation Technology.