In this, the day and age of the global coronavirus outbreak, the job of the medical translator and interpreter has never been more relevant. Resolving this global crisis involves a great deal of research and analysis, much of it in the form of clinical trials. All of the requisite research and analysis must not only be reported and published but accurately documented as well. Once all of the research from the clinical trials has been completed, the information must be made readily available.
The document translation must be completed by certified medical translators and disseminated globally in order for the research to be relevant and helpful. This is an absolutely crucial role during any medically related global crisis but the medical translation of the clinical trial documentation will ultimately be the key to bringing the COVID-19 global pandemic to a successful conclusion before it can get any worse for the people of the world.
In tandem with the need for medical translation is the localization of clinical trials, which requires additional paperwork that the medical translator must make accessible to the world.
Document Requirements for Domestic and International
According to the National Institute of Health, “One of the most common inspection findings in investigator site inspections is lack of reliable, accurate and adequate source documentation. This also happens to be the most common pitfall identified during sponsor audits. The importance of good documentation practice needs to be emphasized to investigator sites to ensure that the study results are built on the foundation of credible and valid data.”
One of the biggest concerns during the current global medical crisis is that many of the clinical trials will not be properly published at all. Of those that are, many will suffer due to the improper documentation and document recordings, and all this before medical document translation begins. Among the biggest culprits of under-reporting, clinical trials were many academic institutions where certified medical translators should be readily available, and clinical trial document requirements should not be a challenge.
A study from the US Food and Drug Administration which is responsible for the oversight and investigation of Clinical Trials in the United States, inadequate documentation records were one of the top causes of clinical trials being brought into question or having them dismissed completely.
Clinical Trial Audits were most commonly required according to the FDA because of the following reasons:
- failure to follow the investigational plan (34%)
- inadequately informed consent form (28%)
- inadequate/inaccurate records (27%)
The amount of documentation required to conduct a clinical trial is overwhelming on the best of days. Every one of the documents is absolutely relevant to the successful conclusion of the clinical trials being conducted by medical researchers.
This is especially true in terms of the current global Covid-19 pandemic. In terms of global clinical trials, translation services should work in support of the global effort, though this also requires that all of the documentation is in order, to begin with. Further, it relies on medical researchers working with a certified medical translation agency that also has the capacity to integrate and implement successful localization strategies to ensure the accuracy of the medical translations before they are distributed globally.