Q1169. How to process phase 1-3 clinical trial report translations?

Answered by the NYC Visa & Translation certified translation team

Phase 1–3 clinical trial reports for Thai FDA submission follow the ACTD/CTD structure, and the translation practice is shaped by the reports' role as regulatory evidence of safety and efficacy. The document set: the clinical study reports (the full CSR with its protocol, statistical analysis plan, and results), the investigator's brochure, the informed consent documents, and the ethics committee approvals — for multinational trials including Thai sites, the Thai site's documents go into the global dossier in English; for foreign trials supporting Thai registration, the reports are submitted with Thai summaries or full translations per the Thai FDA's requirements for the specific filing. Translation rules that matter: the efficacy and safety results are the evidentiary core — the statistical outputs (the endpoints, the confidence intervals, the p-values) are transcribed exactly with the analysis populations identified; the adverse event tables use MedDRA terminology (the standard medical dictionary for regulatory activities — its terms have settled translations); and the protocol deviations and the data integrity statements are compliance text translated completely. Points that matter: the informed consent forms for Thai subjects are translated into Thai with back-translation validation (the ethics committees require it — the consent must be genuinely understandable at the subjects' literacy level); the trial's registration records (ClinicalTrials.gov, the Thai clinical trials registry) are part of the transparency set; and the GCP compliance statements anchor the report's acceptability. Practice points: the CSRs are long (hundreds of pages with appendices) — scope the translation with the regulatory affairs team on what the specific filing requires; and maintain the MedDRA and protocol terminology consistently across the trial's document family.