Good practice of clinical drug trials /

Bibliographic Details
Main Author: Spriet, Alain
Other Authors: Dupin-Spriet, Thérèse
Format: Book
Language:English
Published: Basel ; New York : Karger, [1992]
Subjects:
Table of Contents:
  • Introduction
  • Bad clinical practices
  • Good clinical practices
  • Protection of participants
  • Writing the protocol
  • Designing the case report forms
  • Monitoring of clinical trials
  • Data management
  • Drug manufacturing
  • Drug packaging
  • Drug labelling
  • Test drug: in use
  • Clinical laboratory data
  • Adverse events
  • Trial report
  • Filing and archiving
  • Audit and inspection.