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	Nghiên cứu Giai đoạn IV Đa trung tâm	Nghiên cứu đoàn hệ đa trung tâm
Lĩnh vực	Dịch tễ học	Dịch tễ học
Họ	Process / pipeline	Process / pipeline
Năm ra đời	1980s–1990s (formalized with post-marketing requirements in modern drug regulation)	Mid-to-late 20th century (widespread adoption 1970s–1990s)
Người khởi xướng	Regulatory agencies and pharmaceutical industry (ICH E2E, FDA, EMA post-marketing frameworks)	Developed incrementally through large collaborative epidemiological projects (e.g., Framingham Heart Study consortium expansions, 1948 onward; EPIC study, 1992)
Loại	Observational or interventional post-marketing study	Observational longitudinal study
Công trình gốc	Strom, B. L., & Kimmel, S. E. (Eds.). (2005). Textbook of Pharmacoepidemiology. John Wiley & Sons. ISBN: 978-0470029619	Rothman, K. J., Greenland, S., & Lash, T. L. (2008). Modern Epidemiology (3rd ed.). Lippincott Williams & Wilkins. ISBN: 978-0781755641
Tên gọi khác	multicenter post-marketing study, multicenter pharmacovigilance study, multi-site phase IV study, post-authorization safety study	multisite cohort study, multi-centre cohort, collaborative cohort study, pooled cohort study
Liên quan	6	6
Tóm tắt	A multicenter Phase IV study is a post-marketing surveillance investigation conducted simultaneously at two or more clinical or research sites after a drug, device, or intervention has received regulatory approval. By pooling real-world data from diverse patient populations and geographic regions, it detects rare adverse events, evaluates long-term effectiveness, characterizes safety in subgroups, and fulfills regulatory post-authorization commitments that single-site studies cannot achieve.	A multicenter cohort study follows defined groups of participants at two or more geographically or institutionally distinct sites over time to estimate incidence, identify risk factors, and quantify associations between exposures and outcomes. By pooling data from multiple centers, it achieves statistical power and population diversity that single-site designs cannot match, making it the workhorse of large-scale epidemiological and clinical research.