28 Nov Translation of clinical trials: the essential glossary

Clinical research generates a large amount of documentation. That is why when clinical trial translation is required, a specialised medical translation agency is needed. The vocabulary used in clinical trials is not without its difficulties. Below we have selected some of the most common terms used in the translation of clinical trials.

What is clinical trial translation?

All clinical trials require the preparation of various written documents, from informed consents describing all the details of the study, clinical protocols describing the objectives, methods and organisation of the clinical trial, to reports with the results communicated by patients. These formal documents are highly specialised and complex in nature, as they involve the use of medical and technical terminology. Therefore, the professionals who prepare these documents require the services of a medical translation agency to translate these documents in order for patients to understand their content.

Glossary of Clinical Trial Translation Terms

Adverse Event: Any untoward medical occurrence in a patient or clinical research subject after being given a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. An adverse event can therefore be any unfavourable and unexpected sign (including an abnormal laboratory finding), symptom or disease temporally associated with the use of an investigational product, whether or not it is related to this product.

Good Clinical Practice (GCP): Guidance for the design, conducting, compliance, monitoring, auditing, recording, analysis and reporting of clinical trials that ensures that the data and results obtained are correct and credible and that the rights, integrity and confidentiality of trial subjects are protected.

Ethics and Review Committee (ERC): An independent body (a regional, national or supranational review board), consisting of scientific/medical professionals and non-scientific/non-medical members, whose responsibility is to ensure the protection of the rights, safety and welfare of human subjects involved in a trial, as well as to provide public assurance of this protection by, among other things, reviewing and approving (granting a favourable opinion) the trial protocol, the suitability of the investigator, the facilities and the materials and methods to be used in obtaining and documenting informed consent from trial subjects.

Scientific Research Ethics Committee (REC): An independent body made up of medical, scientific and non-scientific members, whose responsibility is to guarantee the protection of the rights, safety and welfare of the human subjects involved in a trial, as well as to ensure the scientific validity and ethical and social justification of the trial. This activity is carried out, among other things, through the review, approval and continuous supervision of the protocol of a trial and its amendments, as well as the material and methods to be used in obtaining the informed consent of the subjects participating in the trial.

Protocol: A document that describes the objective(s), design, methodology, ethical considerations, statistics, and organisation of a trial. The protocol usually also provides the background and rationale for the trial, although both may be made explicit in other documents referenced in the protocol. The term protocol also includes modifications that are made during the execution of the protocol.

The list of terms that appear in clinical trials is endless, although these are some of the most frequent ones in this type of document. Do you need a medical translation? Contact us!