[ICH-GCP Guideline: quality assurance of clinical trials. Status and perspectives]

Ugeskr Laeger. 2003 Apr 14;165(16):1659-62.
[Article in Danish]


Good Clinical Practice (GCP) is an international ethical and scientific quality standard for designing, conduction, recording and reporting trials that involve the participating of human subjects. Since 1997 the ICH-GCP Guideline has been a requirement for conducting clinical trials which should be used as documentation to the authorities. The 13 fundamental principles of the ICH-GCP Guideline for conducting clinical trials are described. Furthermore, the most essential responsibilities of the investigator, sponsor and sponsor-investigator are mentioned. Investigator-initiated trials do not need to be conducted according to the GCP-principles but after the implementation of the EU Directive 2001/20/EC this will be changed. Today the GCP-principles only apply to clinical research with drugs but within a few years the GCP-principles will probably be a requirement for all clinical research.

Publication types

  • English Abstract
  • Review

MeSH terms

  • Adverse Drug Reaction Reporting Systems / standards
  • Clinical Trials as Topic / standards*
  • Denmark
  • Drug Approval*
  • Drug Monitoring / standards
  • Guidelines as Topic
  • Humans
  • Informed Consent
  • International Cooperation
  • Quality Assurance, Health Care*
  • Research Personnel / standards
  • Research Subjects
  • Research Support as Topic