Delivering Translated Informed Consent Forms Ahead of the Timeline
Enhancing Patient Understanding and Safety
Overview
Linguamatics efficiently handled the translation of over 30 Patient Consent Forms (ICFs) into 13 languages within a span of 8 days, successfully delivering ahead of schedule. This task was crucial for complying with the EU Clinical Trials Regulation (EU CTR) for a major pharmaceutical company, ensuring prompt and precise EU-CTR submissions.
Solution
Language solutions
Industry
Pharmaceuticals Clinical Research Organizations (CRO)
The problem
The EU Clinical Trials Regulation (EU CTR) set forth comprehensive requirements for translating clinical trial documents. These guidelines emphasized the necessity of informed consent in clinical trials, which included the use of ICFs to ensure participants were properly informed and protected throughout the trial.
Accurate translations were essential to meet the diverse requirements of various local authorities, preventing regulatory approval delays. Any inaccuracies or delays could result in the trial application being rejected.
The solution
Effective and transparent communication between the client and the Linguamatics team was pivotal to the project's success. Linguamatics confronted these challenges with a thorough language solutions framework designed to satisfy the rigorous demands of the EU CTR:
- Regulatory Compliance: Precise translation of essential documents into multiple languages as required by 13 Member States.
- Patient Safety: Layperson translations ensured that consent forms were clear, enabling participants to fully understand the risks and benefits involved.
- Quality Framework: A stringent quality framework that facilitated the delivery of translations within tight deadlines while maintaining high standards of accuracy and reliability.
Results
Linguamatics addressed EU CTR compliance through a strong language solutions framework, prioritizing regulatory adherence, patient safety, and quality. They successfully translated 30+ ICFs into 13 languages in under 8 days, securing timely approvals, enhancing patient understanding and safety, and improving operational efficiency. The trial’s participants received the crucial information needed to make informed decisions regarding their involvement in a CNS clinical trial.