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Understanding and Addressing Regulatory Concerns in Research

  • Jason L. Koh
  • Denise Gottfried
  • Daniel R. Lee
  • Sandra Navarrete
Chapter

Abstract

Regulatory considerations must be carefully evaluated prior to conducting clinical research to maximize time and money while remaining compliant with set forth regulations and guidelines. Each country has their own regulations, but many regulatory bodies are working together to become more efficient in their processes. For example, the objective of the International Conference on Harmonisation is to provide a standard in which different countries have mutual acceptance of clinical data and thus a streamlined review process. The new researcher should be familiar with the regulatory agencies that are working together and those that have stand-alone regulations to ensure that the research meets applicable health, safety, and ethical standards. Further, to ensure the appropriate approval pathway and to develop a robust and compliant clinical study, an overview of international regulatory considerations during all phases of research is discussed.

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Copyright information

© ISAKOS 2019

Authors and Affiliations

  • Jason L. Koh
    • 1
    • 2
  • Denise Gottfried
    • 3
  • Daniel R. Lee
    • 4
  • Sandra Navarrete
    • 5
  1. 1.Department of Orthopaedic SurgeryNorthShore University HealthSystemEvanstonUSA
  2. 2.University of ChicagoChicagoUSA
  3. 3.TekTeam, LLCPalo AltoUSA
  4. 4.Scaffold Biologics, Inc.San AntonioUSA
  5. 5.Independent ConsultantAustinUSA

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