Terminology

Question 1

International Conference on Harmonization (ICH)

(FDA Definition)

Answer 1

A document that makes recommendations on information that should be included in a core clinical study report of an individual study of any therapeutic, prophylactic, or diagnostic agent conducted in human subjects

Question 2

Good Clinical Practice (GCP)

Answer 2

A standard for the design, conduct, performance, monitoring, auditing, recording, analysis, and reporting of clinical trials or studies

Question 3

International Council for Harmonization

(UT Definition)

Answer 3

International ethical and scientific quality standard for designing, conducting, recording, and reporting trials that involve human subjects

Question 4

ICH E8

Answer 4

Provides overall guidance on the clinical development lifecycle, including designing quality into clinical studies, considering the broad range of clinical study designs and data sources used

Question 5

ICH E6 (R2)

Answer 5

An international quality standard that is provided by the ICH; provides a unified standard for the European Union, Japan, and the United States to facilitate the mutual acceptance of clinical data by the regulatory authorities in these jurisdictions

Purpose:
> Harmonize technical procedures and standards
> Improve quality and speed time to market
> In 1997, the FDA endorsed the GCP Guidelines developed
> Used as a guidance for the FDA/NIH