A clinical trials manual from the Duke Clinical Research Institute : lessons from a horse named Jim /

A clinical trials manual from the Duke Clinical Research Institute : lessons from a horse named Jim /

Uloženo v:
Podrobná bibliografie
Hlavní autor: Liu, Margaret B.
Korporativní autor: Duke Clinical Research Institute
Další autoři: Davis, Kate (Kate G.)
Médium: Kniha
Jazyk:English
Vydáno: Chichester, West Sussex, UK ; Hoboken, NJ : Wiley-Blackwell, 2010.
Vydání:2nd ed.
Témata:
Clinical trials > Handbooks, manuals, etc.
Drugs > Testing > Handbooks, manuals, etc.
Clinical Trials as Topic > legislation & jurisprudence > United States.
Clinical Trials as Topic > ethics > United States.
Device Approval > United States.
Drug Approval > United States.
On-line přístup:Publisher description
Table of contents only
Contributor biographical information
Tagy: Přidat tag
Žádné tagy, Buďte první, kdo otaguje tento záznam!
Obsah:
  • Lessons from a horse named Jim and other events in history affecting the regulation of clinical research
  • The process : developing new drugs, biologics, and devices
  • Good clinical practice and the regulations
  • Informed consent and the regulations
  • Institutional review boards
  • Adverse events and unanticipated problems involving risks to subjects and others
  • Monitoring, audits, and inspections
  • The principal investigator, the clinical research coordinator, and the study site
  • The protocol
  • Study feasibility : reviewing a specific protocol
  • Study activities
  • Study documents/essential documents
  • Management of study drugs, biologics, and devices
  • Managing clinical trial data
  • Global health and international trials.

Podobné jednotky