Case report forms (also known as CRFs) are questionnaires commonly used in clinical trials for hypothesis testing and data analysis. CRFs are used by clinical trial sponsors and site personnel to collect patient information that informs the study’s efficacy and safety endpoints such as weight, height, respiration, temperature, blood pressure, pulse, date of visit and any adverse events that the patient may experience during the clinical trial. However, the type of data collected can be changed depending on the specific disease being studied and the study protocol. After the data on the CRF is captured, it is analyzed and sent to the sponsor’s database. After the clinical study is over, the CRF data is further analyzed to see the effectiveness of the drug or medical device, and the results are included in the clinical study report.
Although CRFs are traditionally paper questionnaires, electronic CRFs, or eCRFs, have become increasingly popular due to more rapid database lock, enhanced online discrepancy management, and better data quality. In addition, electronic case report forms offer the advantage of facilitating multicentric clinical studies due to more convenient administration. An eCRF also offers the advantage of being able to handle multiple large studies with similar designs.
As the world becomes increasingly global, more and more life science companies are holding clinical trials, especially Phase III trials, in regions where English is not the primary language. For multilingual clinical trials, CRFs and eCRFs play a key role in documenting clinical data that determines if the drug or medical device performed as expected. In addition, since the information in CRFs is required for AE and SAE reporting by regulatory agencies like the FDA and EMA, accurate translations of CRFs are vitally important to not only avoid wasting money through incorrectly entering data, but also maintaining regulatory compliance for clinical trials and proper safety reporting.
Given the importance of CRFs and eCRF in maintaining regulatory compliance and ensuring clinical trial outcomes, high quality and timely CRF and eCRF translation is vital for life science companies to successfully conduct multilingual clinical trials. With a network of 10,000 global linguists and subject matter experts (SMEs), CSOFT provides timely and accurate CRF and eCRF translations backed by stringent quality assurance, enabling life science companies conducting international multilingual clinical trials.