Translations for Clinical Research
As the translation department of the contract research organisation MEDICRO GmbH, we specialise primarily in the translation of all kinds of texts surrounding clinical research and medicine. In today’s globalised world, a wide range of documents has to be translated for clinical trials. On this page you will read about the typical types of texts from this field.
Patient information sheets and informed consent
The patient information sheet contains all the information that could be of interest to potential study participants. Since it is mainly for individuals that are not medical specialists, having a suitable linguistic style for the patient information sheet is especially important. Thus, care must be taken that it is formulated clearly and intelligibly.
This also applies to the accompanying informed consent. It is one of the most important documents that have to be prepared for the conduct of a clinical study. There are different informed consents for various countries, age groups, participants or even their dependents or guardians. In particular, informing the patients about confidentiality, data protection, possible risks and the course of the study is at the forefront here.
Aside from the content, the ethics committees review the linguistic style of the submitted texts. As a result, the layman friendly translation of these documents has particular importance. Even adapting to the Austrian and Swiss standards is of course possible with us.
Protocols and Synopses
A protocol (also known as a study protocol) or clinical investigation plan must be developed for every clinical study and parts of it need to be translated for submission with the competent authorities. The document contains core information on the planned study, such as the sponsor’s details, name of the investigator, information on the statistical approach and the study design. For the approval of a clinical study in Germany, a German synopsis is required.
The protocol is reviewed by the competent ethics committees as well as the competent authorities. These institutions also need to be informed if the protocol is amended following approval.
Regulatory submissions and approvals
Every submission requires regular correspondence with ethics committees and competent authorities. This includes cover letters that are enclosed with notifications and announcements, as well as formal deficiency notifications or positive assessments and approvals from the authorities and ethics committees. These letters must often be translated into English for the sponsor. Are your documents especially urgent? Then why not use our 24-hour turn-around service, established especially for short texts.
Package Leaflets
Without a doubt, every patient has held a package leaflet in their hands at some point and has asked themselves at the sight of the numerous side effects whether they should really take the drug. However, this detailed description of all known side effects is a legal requirement. Additionally, it is specified that the texts needs to be compiled in universally comprehensible German.
Patients Cards, Diaries, etc.
The participants of a clinical study should always have a patient card with themselves over the duration of the study. This document informs treating physicians that the patient is participating in a study and it contains the contact details of the responsible study physician, so that he/she can be reached at all times. Sometimes it is also necessary for the patients to keep a diary in which they regularly record data, such as blood pressure or the time of taking the study drug.
Summary of Product Characteristics (SPC)
The summary of product characteristics contains information on all important properties of a drug. What exactly needs to be included is regulated by the Directive 2001/83/EC. For this reason these texts are highly standardized. So, for example, there is a fixed information order and established headings. Later on, the package leaflet is compiled based on the SPC.
Contracts
Agreements and contracts are also an important element of clinical trials. We are happy to support you in the translation of investigator agreements, study nurse agreements, equipment loan contracts or also agreements with the trial site.
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