ICH Step 4 Guidelines
 

ICH Harmonised Tripartite Guideline for Good Clinical Practice (with EC Directive)

  • Contains full text of the principles of ICH GCP, updated 1997
  • Absolutely essential

ISBN 1-874409-74-9


ICH Harmonised Tripartite Guideline for Good Clinical Practice

  • Contains full text of the principles of ICH GCP, updated 1997
  • Absolutely essential

ISBN 1-874409-47-1


ICH Harmonised Tripartite Guideline for General Considerations for Clinical Trials

  • The general principles and development methodology is neatly and concisely presented
  • Full ICH text reproduced in a very readable format

ISBN 1-874409-91-9


ICH Harmonised Tripartite Guideline for Data Elements for Transmission of Individual Case Safety Reports

  • Guidelines presented in a concise and structured manner
  • Easy to read with full ICH text transcript

ISBN 1-874409-02-1


ICH Harmonised Tripartite Guideline for Statistical Principles for Clinical Trials

  • Full ICH consideration text.
  • Clearly presented and annotated for easy referencing

ISBN 1-874409-07-2


Russian Translation of ICH GCP Guidelines

This booklet is a translation of the ICH GCP guidelines, which provides a model for the EU, Japan and USA on how to achieve mutual acceptance of clinical trial data by regulatory bodies.

ISBN 1-874409-73-0