Poor or inconsistent translations in clinical trials create real risks – participants may misunderstand informed consent, dosing instructions, or how to report adverse events, which can endanger safety and produce unreliable data. Regulators may also reject or delay submissions if documents aren’t linguistically and culturally appropriate, leading to costly rework and lost time.
Understanding and applying translation requirements – qualified life sciences translators, documented workflows, linguistic validation, and cultural adaptation – prevents these problems. Clear, validated translations improve participant engagement, reduce protocol deviations, strengthen audit trails, and increase the likelihood of reliable study outcomes. This article will cover everything you need to know about translation requirements for clinical trials, so you can maintain compliance and gain more valuable trial data.
What Components of a Clinical Trial Need to Be Translated?
Below are some of the common documents and materials that need to be translated for clinical trials:
- Informed consent forms (ICFs)
- eConsent interfaces
- Participant information sheets and FAQs
- Patient-reported outcome (PRO) questionnaires and assessments
- Recruitment materials and advertisements
- Dosing instructions, medication guides, and patient leaflets
- Adverse event reporting instructions for participants
- Site training materials, slide decks, and SOPs for study procedures
- IRB/ethics committee submissions and responses
- Contracts, clinical trial agreements, and subject privacy/HIPAA authorizations
- Instructions for use (IFU) for medical devices and kit inserts
- IMP labeling, packaging, and pharmacy dispensing instructions
7 Most Important Translation Requirements for a Successful Clinical Trial
Below are 7 important translation requirements for successful clinical trials, all of which our team at Conversis can assist you with:
1. Qualified Medical Translators
Use qualified translators who have demonstrable experience with clinical terminology and trial documents. This approach catches both linguistic errors and clinical misinterpretations – preserving language nuance, clinical intent, and patient safety. Ideally, you should partner with a language service provider (LSP) that holds certifications such as ISO 9001 and 17100, as this demonstrates their commitment to quality translation and best practice.
2. Clear Source-Language Control
Designate one approved master document and enforce that all translations originate from that version. Maintain a change log so every amendment, annotation, and decision is traceable; this prevents conflicting translated versions at sites and avoids regulatory issues during inspections.
3. Linguistic Validation & Cognitive Debriefing
For consent forms, PROs, and any instrument measuring participant responses, perform formal linguistic validation: forward translation, reconciliation, back-translation (where appropriate), and cognitive interviews with target-language participants. These steps test comprehension and conceptual equivalence so scores and consent are meaningful and comparable across populations.
4. Cultural Adaptation
Adjust idioms, examples, units, date/time formats, and culturally-sensitive references rather than translating literally. Cultural adaptation reduces confusion or offense, improves recruitment and retention, and ensures that questions measure the same construct in different settings.
5. Regulatory & Ethics Compliance
Identify regulatory and IRB/ethics committee rules early on – some jurisdictions require translations of the full protocol, consent, recruitment copy, or specific appendices for submission. Build submission checklists and include timelines for translated documents so approvals and site activation aren’t delayed.
6. Independent Linguistic Review
This is where back translation is often deployed to help identify subtle shifts in meaning for critical materials – such as ePRO items or regulatory text. Alternatively, two independent linguistic reviews can offer an equally robust and often more efficient approach.
7. Quality Assurance, Certification, & Audit Trail
Implement quality assurance steps, such as bilingual editing, reviewer sign-off, and certification of final deliverables where required. Keep auditable records of translators used, reviewer comments, version histories, and approval dates to demonstrate compliance during regulatory submission reviews.
How Can You Ensure These Requirements Are Met?
Language service providers like Conversis act as the single operational partner that designs and delivers end-to-end language support across a clinical trial. An experienced LSP can handle each of the tasks in the previous section with both exceptional accuracy and efficiency. By centralizing project management, technical tools, and documented processes, an LSP keeps translations consistent, auditable, and aligned with regulatory expectations throughout the study lifecycle.
Benefits of Partnering With a Language Service Provider
- Extensive Expertise: Partnering with a specialist LSP gives you access to translators and reviewers who specialize in clinical content, regulatory language, and patient-facing materials, therefore reducing errors and preserving clinical intent.
- Time-Saving: Centralized workflows, distributed tasks, and experienced project managers accelerate turnaround times for translations and amendments.
- Cost-Effectiveness: Translation memories, glossaries, and repeatable workflows reduce costs over the life of a program and minimize expensive rework from e.g. regulatory queries.
- Multi-Language Support & Scalability: Ability to cover many languages, dialects, and locales simultaneously and scale up quickly for multi-national trials or quick-turnaround amendments.
- Regulatory Compliance & Audit Readiness: Controlled documentation, certification, credentials, and an auditable trail that helps satisfy IRB/EC and regulator requirements.
What Regulations Must Clinical Trial Translations Adhere To?
Here are some of the main regulatory bodies that shape translation expectations for clinical research, and information on how their rules promote transparency and protect participants:
U.S. Food and Drug Administration (FDA)
The FDA requires that written and oral information given to trial subjects be understandable and complete; its recent informed-consent guidance emphasizes clarity and documentation of consent processes. These expectations mean sponsors must ensure translations of consent and other participant-facing materials are accurate, comprehensible, and auditable.
European Medicines Agency (EMA) & EU Clinical Trials Regulation (EU CTR)
The EMA implemented the EU CTR (Regulation (EU) No 536/2014), which then introduced the Clinical Trials Information System (CTIS) and stronger transparency rules. The CTR and related guidance require that participant-facing documents be available in the language(s) of trial participants and establish harmonized submission and public-reporting requirements across all member states.
International Council for Harmonisation (ICH) & Good Clinical Practice (GCP)
ICH GCP E6 (R3) sets the international standard for protecting trial participants and ensuring data integrity; it explicitly states that information given to subjects must be non-technical and understandable, which emphasizes the need for high-quality, validated translations and linguistic checks.
Why These Regulations Matter
Together, these regulations aim to ensure that participants truly understand what joining a trial entails, that safety information is consistently communicated, and that trial results are reported transparently and reliably. High-quality, validated translations are therefore a practical requirement for protecting participants, maintaining data integrity, and meeting regulatory expectations.
Partner With Conversis to Streamline Your Clinical Trial Translations
Make your next clinical trial simpler and safer with Conversis. Backed by industry accreditations and over 3,000 specialist linguists, we combine exceptional expertise with AI-powered workflows to deliver faster, more consistent, and fully-auditable translations that regulators – and participants – can trust.
For more information about what’s involved in our translation services and how we can help you, please get in touch with our team today.
