IRB review of adverse events in investigational drug studies

IRB. Nov-Dec 1997;19(6):1-4.
No abstract available

MeSH terms

  • Consent Forms
  • Cost-Benefit Analysis
  • Drug-Related Side Effects and Adverse Reactions*
  • Drugs, Investigational*
  • Ethical Review*
  • Ethics Committees*
  • Ethics Committees, Research*
  • Ethics*
  • Federal Government
  • Government
  • Government Regulation
  • Human Experimentation*
  • Humans
  • Informed Consent
  • Mandatory Reporting
  • Research Personnel
  • Research Subjects
  • Risk
  • Risk Assessment
  • Social Control, Formal
  • United States
  • United States Food and Drug Administration

Substances

  • Drugs, Investigational