Clinical Trial Protocols and Consent Forms - Translated for Ethics Committees, Regulators, Investigators and the Patients Who Sign

The clinical trial document set

A clinical trial generates documents for four readers. For the ethics committee and the regulator: the protocol and its synopsis, the investigator's brochure, the informed consent form and patient information sheet, the recruitment materials, the insurance certificate, the investigator's CV and the site's documents, submitted in Georgian with the English originals; for the investigators and site staff: the protocol, the brochure, the case report forms, the study manuals and the training materials, used in English at most Georgian sites but translated where staff need them; for the patients: the consent form, the information sheet, the patient diary, the questionnaires and quality-of-life instruments, the study card and the recruitment materials, all in Georgian and, for Georgia's minority communities and foreign patients, in Russian, Azerbaijani, Armenian or another language; and for the sponsor and the CRO: the site's local documents translated back into English - the ethics committee's opinion and correspondence, the regulator's authorization, the site agreement, source documents and SAE reports. We translate every category with physician and pharmacist translators who know Good Clinical Practice, the ICH guidelines and the regulator's requirements.

Informed consent: back-translation and reconciliation

The informed consent form and patient information sheet are the documents a patient reads before agreeing to take part, and the ethics committee reads them for comprehensibility as well as accuracy: the study, its risks and its alternatives must be explained in plain language at a reading level the patient can follow, in the patient's language, without technical terms the source uses for investigators. International sponsors and Georgian ethics committees require a back-translation process for these documents: the English source is translated into Georgian by one medical translator, translated back into English by a second translator who has not seen the source, and the two English versions are compared and reconciled by a reviewer, with every discrepancy documented and resolved in the Georgian text, and a certificate of translation and reconciliation issued for the submission. We run this process for consent forms, information sheets, patient diaries, questionnaires and patient-reported outcome instruments (for which the instrument's owner may also require linguistic validation with cognitive debriefing, which we coordinate), and we deliver the reconciliation report in the sponsor's format.

Protocols, investigator brochures and the regulator

Protocols and investigator brochures are long, technical and revised repeatedly, and the ethics committee and the regulator read the Georgian versions against the English. We translate protocols with the study design, objectives, endpoints, eligibility criteria, procedures, schedule of assessments, statistical methods and safety reporting rules rendered in the terminology Georgian clinicians and the regulator use, with abbreviations and defined terms consistent throughout and across the brochure and the consent form, and we translate protocol amendments as tracked changes against the previous Georgian version so that the committee sees exactly what changed. Investigator brochures are translated with pharmacist translators for the pharmacology, toxicology and clinical data sections and physicians for the clinical guidance. Submissions to the Georgian regulator and ethics committees follow their templates and language requirements, and we prepare the translated set in submission order with the certificates of translation the committee requires.

Safety reports, source documents and site correspondence

During the trial, documents flow in both directions on deadlines set by GCP and the protocol. Serious adverse event reports and SUSAR notifications from Georgian sites are translated into English for the sponsor within the reporting timelines; source documents - hospital records, laboratory reports, imaging - are translated for monitors and auditors; the ethics committee's opinions, queries and annual review correspondence are translated for the sponsor; protocol deviations, monitoring visit reports and audit findings are translated as required; and the regulator's authorization, amendments and end-of-trial notification are translated for the trial master file. We translate these with the same medical team that translated the protocol, from the trial's glossary, on the trial's timelines, and we provide interpreters for sponsor and CRO visits, investigator meetings and audits at Georgian sites.

Version control, glossaries and quality

Clinical trial translation is managed as much as it is written. Each document carries a version and date that must match the sponsor's version control; each trial has a glossary of defined terms, drug names, procedures and abbreviations, agreed with the sponsor's medical writer or the principal investigator at the start and enforced across every translator and every document with translation memory; each patient-facing document has a documented back-translation and reconciliation; each delivered document has a certificate of translation naming the translator's qualification; and the whole set is stored so that a monitor or auditor can trace every version. Our process follows the sponsor's SOPs where the sponsor has them and our own GCP-aligned procedure where it does not, and it is documented for inspection. Trial documents are handled under NDA on secure platforms with restricted access.

Pricing, timing and how to order

Clinical trial documents are priced per page at the medical tariff, with back-translation and reconciliation priced as a process per document, linguistic validation with cognitive debriefing as a project, and framework rates for sponsors and CROs with ongoing trials; certificates of translation are included, and notarization is added where a committee or the regulator requires it. A consent form with back-translation and reconciliation takes three to five business days; a protocol one to two weeks depending on length; amendments and safety reports on the trial's timelines.

To order, send the document set with its version numbers on email, and tell us the sponsor's SOPs, the ethics committees and the submission date; we reply within the hour with a fixed quote, the medical team, the process for each document category and a schedule aligned with the submission. Delivery is by email or on the sponsor's platform in the original format, with certificates of translation and reconciliation reports in the sponsor's templates.

Frequently asked questions

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