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Related Experiment Videos

Good clinical practices: past, present, and future

R L Goodson1

  • 1Sanofi Winthrop, Inc., New York, New York 10016, USA.

Quality Assurance (San Diego, Calif.)
|March 1, 1995
PubMed
Summary
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Clinical quality assurance, rooted in Good Clinical Practices (GCPs), ensures research integrity. Voluntary adoption of quality assurance units and auditing functions worldwide highlights its critical role in science, medicine, and ethics.

Area of Science:

  • Clinical research
  • Medical ethics
  • Scientific integrity

Background:

  • Clinical quality assurance evolved from Good Clinical Practices (GCPs).
  • GCPs provided foundational elements for quality assurance in research.
  • Historical development of GCPs spurred the creation of quality standards.

Observation:

  • The research community proactively established quality assurance units.
  • Auditing functions were voluntarily implemented to uphold high research standards.
  • Clinical quality assurance, though unregulated in the US, is globally recognized.

Findings:

  • Good Clinical Practices are integral to the clinical research process.
  • Quality assurance significantly impacts the global research community.

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  • International guidelines (EC, WHO, ICH) emphasize GCP-related activities.

    • Implications:

    • The global adoption of GCPs underscores their importance in research.
    • Standardized quality measurements are essential for reliable scientific outcomes.
    • Future clinical research will likely see increased focus on regulated quality assurance.