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Good Clinical Practice

This document provides an overview of readings and learning objectives for a lesson on good clinical practice (GCP) requirements. It discusses FDA regulations and ICH GCP guidelines for clinical trials. The lesson will compare FDA and ICH requirements on topics like responsibilities of sponsors and investigators, and regulations on investigational new drugs. Students are assigned a project to choose 4 topics and compare the similarities and differences in how FDA regulations and ICH guidelines approach those topics.

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tarak577
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287 views4 pages

Good Clinical Practice

This document provides an overview of readings and learning objectives for a lesson on good clinical practice (GCP) requirements. It discusses FDA regulations and ICH GCP guidelines for clinical trials. The lesson will compare FDA and ICH requirements on topics like responsibilities of sponsors and investigators, and regulations on investigational new drugs. Students are assigned a project to choose 4 topics and compare the similarities and differences in how FDA regulations and ICH guidelines approach those topics.

Uploaded by

tarak577
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as PDF, TXT or read online on Scribd
  • Weekly Readings Overview: Provides a summary of the week's readings including FDA regulations, investigational drug applications, and GCP sections.
  • Learning Objectives: Outlines learning objectives focusing on GCP requirements, differences between FDA and ICH guidelines, and the week's project.
  • GCP and Regulations Overview: Discusses the importance of FDA regulations and ICH GCP guidelines in clinical trials.
  • GCP Comparison Project: Describes a project focused on comparing FDA and ICH requirements based on selected topics.

Good Clinical Practice

This week’s readings:

• FDA Regulations Overview - Hirschfield PPT [30 slides]


• 21 CFR 312 - Investigational New Drug Application (IND), Subpart D –
Responsibilities of Sponsors and Investigators [9 pages]
• ICH-GCP E6 sections 4 and 5, pp 83-93

Clinical Research Regulations 1


Good Clinical Practice
Learning Objectives:

Discuss the GCP requirements associated with FDA regulations (21 CFR)
and ICH guidelines (E6)
Cite the differences and similarities between FDA and ICH GCP
requirements
Discuss This Week’s Project – GCP Comparison

Clinical Research Regulations 2


Good Clinical Practice
• FDA regulations are the law for trials in the US
• ICH GCP Guidelines (E6) have been accepted by most countries in the
world
• The FDA considers ICH GCP to be the Agency’s current thinking on
GCP

Clinical Research Regulations 3


Good Clinical Practice
Project – GCP Comparison

Read the Paul Below article discussing differences between FDA and
ICH
Choose 4 of the 6 topics
Compile your comparison and discuss the similarities and differences
between FDA and ICH for the 4 topics that you selected

Clinical Research Regulations 4

Good Clinical Practice This week’s readings: • FDA Regulations Overview - Hirschfield PPT [30 slides] • 21 CFR 312 - Investig
Good Clinical Practice Learning Objectives: Discuss the GCP requirements associated with FDA regulations (21 CFR) and ICH gu
Good Clinical Practice • FDA regulations are the law for trials in the US • ICH GCP Guidelines (E6) have been accepted by mos
Good Clinical Practice Project – GCP Comparison Read the Paul Below article discussing differences between FDA and ICH Choos

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