Clinical Investigation Plan临床研究计划
A clinical investigation plan is the protocol document that defines the rationale, objectives, design, methodology, monitoring, and statistical considerations for a medical device clinical investigation. It appears in clinical evaluation and regulatory submissions for medical devices and must be approved by ethics committees and, where applicable, competent authorities before the investigation begins.
Updated
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, the CIP appears in medical device clinical investigation applications, ethics submissions, and investigator site documentation. Translators may adapt the plan for multiple study sites, patient consent materials, or monitoring plans, and must align terms with the device description and risk documentation.
Translation checks
A common error is translating “clinical investigation plan” as a generic study schedule or business plan, losing its regulatory role as the controlling protocol. Merging CIP terminology with drug trial protocol terms can also create confusion about device endpoints, investigational device status, or safety reporting.
Chinese document application
Clinical Investigation Plan in context · clinical plan
- English source
- Use the current clinical investigation plan.
- Chinese rendering to review
- 使用现行临床试验方案。
Illustrative wording only. Confirm the rendering against the actual source and approved project terminology.
Check the distinction in context
The approved project terminology may distinguish a clinical investigation from another kind of study. Follow that context and preserve plan version, visit names and linked forms. The translated title does not establish approval of the investigation or permission to begin it.
Check the returned Chinese file
Compare the Chinese plan title, version field and schedule caption. They should identify the same study document, while a related participant form keeps its own document identity and revision in the delivery inventory.
Prepare the connected files
Include the plan revision, schedule and companion-file list. Ask the sponsor or responsible owner to confirm terminology and any market-specific document requirements.
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
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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.