Planning Turkish clinical trial translations starts with a clear document inventory, an agreed source version and a defined review process. For sponsors, CROs and study teams working with sites in Türkiye, these decisions help establish a realistic translation scope before files enter production.
Use this checklist to prepare a translation brief for English-to-Turkish or Turkish-to-English clinical research documents. It is a project-planning guide; your study team should confirm the applicable submission requirements and document approvals separately.
1. Identify the documents and their intended readers
List each document by title, purpose, audience and language direction. A protocol, a participant information sheet and a site instruction sheet serve different readers, so the translation brief should explain how each file will be used.
- Study documents: protocols, synopses, amendments and supporting materials included in the agreed scope.
- Participant-facing materials: information sheets, consent forms, diaries and instructions.
- Site materials: study manuals, training documents and operational communications.
- Ethics and regulatory correspondence: the specific documents identified by the responsible study team.
- Safety and pharmacovigilance materials: clearly identified document types, deadlines and review responsibilities.
This is a scoping list, not a statement that every document requires translation in every study. For questionnaires or licensed instruments, check whether an authorised Turkish version exists and what permissions or adaptation procedures apply before commissioning new work.
2. Confirm the source version before translation begins
Provide the approved source files wherever possible. Record the document identifier, version number and date, and identify any files that are still being revised. Include editable originals alongside reference PDFs when available.
For example, if a protocol amendment changes terminology used in a participant information sheet, flag both files in the brief. An illustrative change log can record the affected section, source change, translation status and reviewer decision. This helps the team track related updates without assuming that an earlier translation remains current.
3. Supply terminology and reference materials
Share approved study terminology, abbreviations, previous translations and any sponsor style guide. State which references take precedence if they conflict, and nominate a contact who can resolve terminology queries.
Participant-facing wording also needs a clear brief about the intended reader. Review readability alongside meaning, while preserving the substance of the approved source. Any proposed change to that substance should be referred to the responsible study team.
4. Agree the review and quality-control scope
Define the checks and deliverables before production starts. Depending on the material and agreed scope, these may include translation, bilingual revision, terminology checks, proofreading and a final layout check. Identify who reviews the Turkish text and who authorises release.
If back translation is requested, confirm the documents covered, the comparison process and who will resolve differences. Back translation is a distinct task; it should not be presented as interchangeable with proofreading or as a complete linguistic-validation process.
5. Plan file handling and delivery
Agree how files will be transferred, who needs access and which deliverable formats are required. Start the quotation process with document types, approximate volume, language direction and timing. Where confidential material is needed for a detailed assessment, agree an appropriate transfer route first.
- Required delivery date and any staged deliveries.
- Time reserved for queries, study-team review and final corrections.
- Clean files, tracked changes or bilingual versions, as applicable.
- Document naming, version labels and formatting expectations.
- Ownership of final approval and subsequent amendments.
A concise brief you can send to your translation partner
Include: document list; source and target languages; audience and intended use; source version and date; approximate volume; reference materials; review requirements; delivery formats; deadline; and a nominated reviewer. Clearly mark any unresolved questions.
A complete brief also makes proposals easier to compare: translation, revision, back translation, formatting and amendment work should be identifiable within the agreed scope.
Discuss your clinical translation requirements with Dilde
Dilde supports clinical research translation projects with terminology-aware workflows and a defined review scope. We can discuss support for a specific document package, additional capacity or an alternative language-service resource alongside your existing arrangements.
Request an initial scope assessment with your document types, language pair and target date. Translation and any pilot work are quoted against the agreed scope. Contact Dilde to discuss your project.