Medicine, Pharmaceuticals and Clinical Trial Translation

The second feature is that most of these documents belong to an application or an approval process. A marketing authorisation dossier has to be complete and internally consistent in the form in which it will be submitted to the regulator; clinical trial documents, for their part, have to be ready for the study to begin. Timetable and accuracy are watched at the same time.

The typical set of documents

The documents in this field fall into two large groups: marketing authorisation and clinical research. Each document has a different reader; some are addressed to a regulatory specialist, some to a physician, some directly to the patient.

The level at which each of these documents is approved is gathered together in our document guide. Authorisation dossiers often run to hundreds of pages, and using the same term in the same way from one module to the next matters as much as accuracy on any single page.

Where does the terminology risk concentrate?

In medical terminology the risk arises from the very existence of standard dictionaries: the names of symptoms and adverse events are matched to particular terminology systems, and free translation is not accepted. The translator has to write a symptom not in words of their own but with its recognised equivalent. Then again, the everyday and the clinical senses of the same word diverge; “reaction”, “indication” and “contraindication” cannot be translated on everyday intuition.

The second risk is the expression of doses and units. An error in milligrams, in millilitres, in the frequency of administration or in the route is a safety problem outright. The third area is consent texts: consent presumes that the patient has genuinely understood the risk, and in a language that is not understood, readability comes before richness of terminology.

The regulatory context

Pharmaceuticals and clinical research are bound up with regulatory frameworks both domestic and international. The headings to keep in view in translation are these:

• In Türkiye, medicines and medical devices sit within the regulatory framework of TİTCK, and in application documents institutional terminology is expected to sit consistently with official usage.
• For international applications, alignment with the document formats and terminology of authorities such as the EMA or the FDA carries weight.
• In clinical trial documents, the standard wording used within the framework of the ethics committee and of good clinical practice must be preserved.
• In consent forms and patient documents, readability is part of what the regulator expects.

TİTCK, the EMA and the FDA are real institutions; the process that applies to any given document, however, varies with the case in hand. Official sources should be taken as the basis for current requirements.

Interpreting in the clinical setting

Translation in this field is not always confined to written documents. Clinical trial visits, informed consent discussions, audit meetings and patient consultations all call for interpreting. This service has a discipline of preparation quite unlike written translation: before the meeting, the interpreter has to be introduced to the terminology of the protocol and of the file. An unprepared interpreter stumbles at the most critical moments.

Medical interpreting has a rule peculiar to itself: the interpreter does not summarise. Every simplification between what the participant or the patient says and what the physician hears means information lost; by the same token the physician’s explanation is carried across without being cut short. The second rule is the boundary of the role: the interpreter does not steer the conversation, does not offer a medical opinion and does not decide on the patient’s behalf. Holding that boundary is necessary both ethically and for the validity of the process.

Tying written and spoken work to the same termbase secures consistency. Where the team that translated a study protocol also takes part in the visits for that same study, uniformity of terminology is preserved and the uncertainties that arise in discussion are reduced.

Why specialist translation is needed

In medical translation, a translator without knowledge of the field can produce a text that is grammatically correct but clinically wrong. A team that knows the standard terminology systems, the architecture of an authorisation dossier and the readability expected of consent forms preserves both safety and consistency. In this field a check by a second specialist is, for most document types, not a preference but a requirement.

Relying on raw machine output is particularly risky here; a dose, a unit or a negative construction can be quietly broken in an automated translation. That is why the last word in medical texts belongs to a human specialist – again, for most document types a requirement rather than a preference.

A check by a second specialist is an established practice as well. In texts that reach the patient directly, consent forms and leaflets above all, whether a reader genuinely understands the text is assessed with a separate pair of eyes. A team at home in standard terminology and in the clinical context can carry out that check to some purpose.

How we work

On the pharmaceutical and research side, the first step in a working relationship is to separate the documents that need a second check from those that need a fast flow. Authorisation dossiers and short safety notifications move at different speeds; once that distinction is drawn at the outset, urgent notifications arrive on time and critical dossiers get the scrutiny they deserve.

For organisations carrying a continuous authorisation and pharmacovigilance load, the framework model is the right fit: the glossary, the second-check flow and the delivery times are set up once. A single protocol or consent translation can be run on a project basis. Our scope of service is set out on the translation services page, and for an arrangement at organisation level we suggest the quote form.

This content gives the general framework; the details specific to a given procedure may differ. We recommend obtaining confirmation from an official source before you proceed.