New Translation and Document Management Regulations under the EU Clinical Trial Regulation (CTR)

The upcoming implementation of the EU Clinical Trial Regulation (Regulation EU No 536/2014), commonly referred to as the CTR, will bring significant changes to the management of clinical trial applications in Europe starting in 2019. The CTR aims to enhance the transparency, coordination, and modernization of clinical operations, but it also presents challenges that impact document and translation processes. Therefore, providing high-quality translations becomes crucial.

Writing and Translation Process of Plain Language Summaries (PLS)

The CTR requires that a Plain Language Summary (PLS) be published within one year after the completion of each clinical trial. These summaries must be provided in the official language(s) of the country where the research was conducted. While translating into other languages is not mandatory, many companies may still choose to meet market demands by providing translations in additional languages.

To improve the quality of the PLS, the document should be written at a sixth-grade reading level, using simple language and clear sentence structures. During the translation phase, several factors must be considered, such as whether back-translation is necessary, how affiliates review translations, and the final format of the delivered documents. Selecting a partner that can transparently manage the entire translation process can effectively streamline workflows and improve document quality.

Creating an Efficient Workflow for Core Country Documents

Although the regulation allows member states to set their language requirements for application materials, companies must submit local documents for trial participants at least at the preliminary assessment stage. Previously, sponsors and Contract Research Organizations (CROs) had some flexibility in translating informed consent forms. However, under the new model, all materials must be ready before the initial deadline, increasing time pressure.

By treating translation as part of the overall document creation and translation workflow, efficiency can be significantly improved. Starting with a global English master document, content management tools can be used to eliminate redundancy, ensure the appropriate reading level, and make the document easier to translate. Subsequently, country-specific customization is carried out, followed by the translation phase. Collaborating with translation professionals experienced in clinical documentation ensures high-quality output. This end-to-end process can reduce translation costs by 30% and cycle times by 50%.

Reviewing the IMP Label Creation and Translation Process

The CTR updates requirements for the immediate and external packaging of Investigational Medicinal Products (IMPs). The efficient preparation of these labels is crucial for the timely initiation of studies, and any delays can severely affect the overall timeline. Improper management of IMP labels can become a bottleneck, especially when it involves sponsors, CROs, and other third-party vendors.

Arrow Translation has developed an efficient process management approach that covers the entire process from label creation, regulatory approval, to translation and proofreading. For a top-ten global pharmaceutical company, this process reduced overall label production time by over 60%.

Ensuring Safety Reporting Processes Comply with Standards

One of the primary reasons for implementing the CTR is to ensure patient safety. The CTR provides essential guidelines for safety reporting processes. When facing urgent regulatory feedback, meeting deadlines is crucial. Establishing efficient workflows for the translation of Serious Adverse Events (SAEs), Suspected Unexpected Serious Adverse Reactions (SUSARs), and CIOMS reports helps minimize the risk of delayed reporting and alleviates pressure on safety and pharmacovigilance teams. Bottlenecks often arise at the handoff points between CROs, sponsors, and translation agencies.

By optimizing these processes, Arrow Translation helps ensure timely safety report submissions, enabling clients to quickly respond to regulatory requirements, and enhancing patient safety monitoring across clinical trials.

◀️：Arrow Translation’s New Practices in the Translatability Assessment of Patient-Reported Outcome Measures

▶️：Arrow Translation's Cross-Language Content Strategy: Bridging Translation Gaps to Enhance User Experience