Investigator Brochure研究者手册
An Investigator's Brochure is a document that compiles clinical and nonclinical data on an investigational product, including formulation details, pharmacology, toxicology, pharmacokinetics, and prior human experience from completed and ongoing studies. It provides investigators, regulatory authorities, and ethics committees with the information needed to assess potential risks, follow dosing guidance, manage expected adverse reactions, and conduct the clinical trial safely.
Angel Translation editorial reference · Confirm the rendering against your source and approved project terminology.
Check source meaning → confirm the preferred term → record approved variants and references.
Where this term appears
In translation and localization, Investigator's Brochure content appears in clinical trial applications, ethics committee submissions, site initiation packages, and investigator-facing documents. Translators also work with toxicology findings, reference citations, dose units, and safety narratives and tables, and must keep terminology aligned with the protocol, informed consent form, and clinical study report.
Translation checks
A common mistake is translating “investigator” as “surveyor” or “researcher” instead of the accepted role title in local clinical trial regulations. Inconsistent rendering of toxicology terms or units such as mg/kg can also make nonclinical safety information unreliable, create confusion in serious risk assessment, and delay regulatory and ethics committee approval.
Keep the term aligned across your files
Check intended use, warnings, document versions and approved terminology with the project team. Translation supports documentation; it does not establish product approval or regulatory acceptance.
Provide approved terms and previous translations with the source files. Agree how variants, ambiguous wording and revisions will be reviewed. Terminology maintenance and any termbase handback are confirmed in the project scope. See the 8-step AI + expert workflow.
Related document experience
NIPRO Medical (Hefei)
Chinese → EnglishMedical-device registration files and technical specifications, in volume.
Read the published project →
Walvax Biotechnology
Chinese → EnglishVaccine-production process documentation, SOPs, quality-control standards and microbiology-testing procedures.
Read the published project →Published scope shows related industry experience; it does not confirm that this specific term was used or reviewed in the project.
Working on life science documentation?
Include the source and target languages, file types, intended use, deadline and any approved termbase. Agree handling before sending sensitive files. Acknowledged in 4 hours, quoted in 24.
Prepare an inquiry email →Life Science solutions →File handling →A glossary entry is not an official standard or evidence of regulatory acceptance. Confirm current requirements for your project separately.