Overview

The majority of Clinical Trials are international and run in multiple countries, so in order to make their conduct successful many trial-related documentation needs to be translated, reviewed, and delivered on time.

The key outcome of each translation project is that the translated documents/materials are accurate and completely convey the content and meaning of the source documents.

Prior to initiating the translation process of any documentations, the Translation Project Manager analyzes and confirms the Customer`s specifications for the translation and CRG’s capability to meet them, determining whether all the necessary human, technical, and technological resources are available.

Aim

The aim of this article is to describe the process of managing translation projects at CRG from the moment they are awarded by a Customer to the agreed completion of the project. At CRG all translation processes are organized and running as per ISO 17100:2015 “Translation services — Requirements for translation services”.

Definitions used in this article

Computer-Assisted Translation (CAT) Tool – a software used by human translators, revisers, reviewers, and others to facilitate their work.

Certificate of Translation Accuracy (usually abbreviated as CoT) – a written statement certifying that the translation has been completed by an experienced, qualified, and competent professional translation team and that the translated text truly reflects the content, meaning and the style of the original text and constitutes in every respect a complete and accurate translation of the original documents.

Domain – a subject field, sphere of knowledge or activity having its own specialized culture, social context, and linguistic characteristics.

Subject Matter Experts (SMEs) – are those individuals with specific expertise and responsibility in a particular area or field.

Source language – a language of the content to be translated.

Target language – a language into which source language content is translated.

Term base – a database containing single words or expressions related to a specific subject. Terms in term bases are often bilingual or even multilingual.

Translation memory – a database in CAT tool that stores sentences, paragraphs or segments of text that have been translated before. Each entry, or segment, in the translation memory includes the original source language and its translation, known as the “target”.

Translation project (process) lifecycle

The process lifecycle is a sequence of the process stages (key and supporting tasks) which illustrates the whole process from the beginning to its closure (see below). The SME review stage is not mandatory and could be requested by the Customer.

Perform the Translation

The Translator performs the translation of the source document(s) in accordance with the purpose of the translation project, including the linguistic conventions of the target language and relevant project specifications. To complete the translation, the Translator makes use of translation glossaries and translation memories, when available, to make sure that standardized and agreed translation terms are used.

Review the Translation

The Reviewer performs the review of the translation, as per the timelines communicated by the Translation Project Manager.

To complete the verification, the Reviewer examines the translation against the appropriate source document(s) (i.e., the original English source document) for any errors and other issues, and its suitability for purpose. The review is performed for the language flow, the edibility of the translated document(s), in order to confirm that the translation is accurate and completely conveys the content and meaning of the source document(s).

Perform the SME Review

The Subject Matter Expert carries out a translation validation to assess the suitability of the target language content for the agreed upon purpose and domain.

Errors identified during translation review process

All errors could be divided into such categories: Accuracy, Language, Terminology, Style, Country and Functional.

They are also further classified as Minor, Medium and Major as per corresponding CRG criteria.

Perform a Final Verification

The Translation Project Manager performs a final verification of the translation against the project specifications indicated in the Customer-CRG agreement concerning the document(s) formatting. If the final verification indicates any deficiencies in meeting these specifications, the Translation Project Manager makes corrections in the target document formatting.

Issue a CoT

The Translation Project Manager issues and signs a CoT and adds it to the package with the translated document(s).

Deliver the Translation

The Translation Project Manager delivers the translated document(s) to a Customer by means and in the format indicated.

CRG in-house translation services

Carpathian Research Group capabilities

Carpathian Research Group as a Clinical Research Organization provides professional translation services and helps our Customers to successfully achieve Clinical Trial goals and objectives. Information on translation services could be found at https://translate.crg.global/