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Related Experiment Videos

Clinical research: regulatory issues.

D P Wermeling1

  • 1Kentucky Center for Clinical Research and Investigator Services, University of Kentucky, Lexington 40536-0082, USA. dwermel@pop.uky.edu

American Journal of Health-System Pharmacy : AJHP : Official Journal of the American Society of Health-System Pharmacists
|February 25, 1999
PubMed
Summary
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Clinical research offices face regulatory challenges. Pharmacists are expanding their roles to manage these offices due to their expertise in Food and Drug Administration (FDA) regulations for investigational new drugs.

Area of Science:

  • Clinical research administration
  • Regulatory affairs in healthcare
  • Drug development and management

Background:

  • Institutions conducting clinical research often lack in-house expertise on regulatory compliance for investigational new drug research.
  • Federal rules and various authorities govern the complex landscape of clinical trial management.
  • Ensuring patient safety and proper billing are critical considerations in clinical research.

Purpose of the Study:

  • To describe the regulatory issues encountered by institutions in clinical research.
  • To highlight the expanding role of pharmacists in managing clinical research offices.
  • To emphasize the importance of proper management in integrated patient care and research programs.

Main Methods:

  • Review of regulatory frameworks governing clinical research.

Related Experiment Videos

  • Analysis of institutional challenges in managing investigational new drug research.
  • Examination of the role of pharmacists in clinical research administration.

    • Main Results:

    • Many institutions lack dedicated regulatory expertise for investigational new drug management.
    • Pharmacists are increasingly tasked with managing clinical research offices due to their understanding of FDA regulations.
    • Compliance with Good Clinical Practice (GCP) and other guidelines is essential.

    Conclusions:

    • Pharmacists' expertise in FDA regulations positions them to effectively manage clinical research operations.
    • Addressing regulatory complexities is vital for successful clinical research programs.
    • Integrating patient care with robust research management is crucial for institutional success.