Clinical Trial Documentation Translation

TARGMANEBI offers sponsors, contract research organisations (CROs), study sites and investigators the translation of clinical trial documentation from English into Georgian, from Georgian into English, and into Russian - with a term base, version control and a non-disclosure agreement signed before any documents are shared.

Who we work for

• Sponsors - pharmaceutical and biotechnology companies opening study sites in Georgia;
• CROs - contract research organisations that manage the documentation of Georgian sites;
• Study sites and investigators - clinics that need documents for the ethics committee, the monitor or an audit;
• Study coordinators - preparing the Georgian part of the package to be submitted to the ethics committee.

Which documents we translate

The informed consent form: the most sensitive document

Under ICH GCP E6, information about the trial must be given to the participant in language they can understand, and the text should not be overly technical. Translating a Georgian ICF therefore means meeting two requirements that pull in opposite directions:

• Legal accuracy - risks, benefits, alternatives, compensation, confidentiality and the right to withdraw from the trial must match the content of the original exactly;
• Readability - the text must be understood by a patient without medical training. In a Georgian ICF, "randomization" is not simply the word "randomization" but an explained process: "your group will be chosen at random, by a computer program".

We keep the explanations that are in the original and add nothing. Where an English term would not be understood by a Georgian patient, we use the Georgian equivalent established in the research field, and we agree any disputed cases with the sponsor or the CRO.

The format of the Georgian ICF and the signature page

The Georgian version of the ICF follows the structure of the original exactly, because the ethics committee and the monitor compare the two versions side by side:

• in the header or footer - the protocol number, version, date and site details, as in the original;
• page numbering in the "page X of Y" format, so that no page goes missing;
• the signature page - with fields for the participant, the legally authorised representative, the person obtaining consent and, where required, an impartial witness;
• checkboxes for optional consents - storage of biological samples, genetic research, future contact.

Date and time fields are written in the Georgian way (day/month/year), so that the participant does not make a mistake when signing.

The protocol and the Investigator's Brochure

The ICF is for the patient; the protocol and the Investigator's Brochure are for the investigator, the ethics committee and the regulator. Here the style is completely different: scientific, precise and terminologically strict. When translating, we pay particular attention to:

• Inclusion and exclusion criteria - a single "and" or "or" means a different patient population;
• Dosing and dose modification schemes - cycles, days, mg/m² calculations;
• The visit schedule - visit windows (± days) and the procedures at each visit;
• Efficacy and safety endpoints - primary and secondary;
• Statistical terms - intent-to-treat, per-protocol, hazard ratio, confidence interval.

The non-clinical part of the Investigator's Brochure - pharmacology, toxicology, pharmacokinetics - requires a separate layer of terminology. That is why the term base is created at the very start of the trial and agreed with the sponsor's medical team.

PRO questionnaires: when not to translate from scratch

Patient-reported questionnaires (quality of life, pain and symptom scales) are often copyrighted instruments. Many of them already have an official, validated Georgian version distributed by the licence holder. In that case no new translation is made - it would break the validation and make the trial data incomparable.

So before work begins, we check which questionnaires already have an official Georgian version and which need a new linguistic validation. If a version exists, we translate only the study-specific additions - instructions, headings, visit notes - and align them with the official version.

The quality system: back translation and version control

In a clinical trial, the quality of a translation has to be proven on paper. For this:

• Forward translation - by a translator with a medical background, using the agreed term base;
• Editing - a second specialist compares the text with the original: doses, number of visits, procedures, deadlines;
• Back translation - at the sponsor's request, an independent translator translates the Georgian text into English without seeing the original;
• Reconciliation - comparison of the back translation with the original, analysis of the differences and, where needed, correction of the Georgian text;
• Translation certificate - a signed document confirming accuracy, which ethics committees often request;
• Version control - every new version of the ICF (for example, v3.0 replacing v2.1) is translated with a comparison file, so that the ethics committee can see the changes quickly.

For the linguistic validation of PRO questionnaires, following the ISPOR recommendations, we carry out the forward translation, back translation and reconciliation stages. Cognitive debriefing interviews with patients are agreed separately with the sponsor or the CRO. The general process: quality control.

Long-term cooperation

A clinical trial runs for years, and documents arrive in waves: first the start-up package, then amendments, new ICF versions and safety reports. A single team keeps the terminology consistent throughout the whole trial. That is why:

• for each sponsor and each trial we keep a separate term base and translation memory;
• the project has a single contact person who knows the history and the versions of the trial;
• for the start-up package and large volumes we draw up a work schedule with delivery in stages, taking the date of the ethics committee meeting into account;
• urgent documents - an SAE report, a minor ICF change, a notification - are ready the same or the next day.

Confidentiality

The study protocol and the Investigator's Brochure are the sponsor's trade secrets, and source documents contain participants' health data. Both require protection:

• the NDA is signed before any documents are shared, on the sponsor's form or ours;
• only the team working on the project has access to the documents;
• the content is not uploaded to AI systems or public machine translation services;
• patient data is processed in line with the Law of Georgia on Personal Data Protection and the principles of the GDPR.

In detail: privacy policy.

How cooperation begins

Frequently asked questions

Related pages