Description

There are a wide range of guidelines and regulations in clinical research. This module introduces the background and history to clinical research guidelines and regulations and explains the difference between a guidelines and a regulation. The module progresses by looking in detail at the relevant guidelines and regulations and provides an essential foundation for anyone involved or wanting to be involved in clinical research.

Who is the Module Designed For?

The course is also essential for anyone working in clinical research and clinical trials who is not familiar with the guidelines and regulations they should be following. This course is designed for anyone wishing to pursue a career in clinical research (including the roles of CRA, CTA, study nurse) whether in a pharmaceutical company, contract research organisation or in a health service/academic setting. The course provides certification of the completion of GCP and Essential Guidelines Training.

Course Content

Background

• History of Clinical Trial Legislation
• Code of Federal Regulations
• ICH GCP

Overview of ICH GCP

• Roles and Responsibilities
• IRB/IEC
• Investigator
• Sponsor
• Monitor
• Protocol and amendments
• Investigators Brochure
• Essential Documents
• Ultimate responsibilities under ICH

Europe

• EU Clinical Trials Directive
• EU GCP Directive
• GMP Directive and Annexe 13

The USA

• FDA Code of Federal Regulations Title 21 Part 312 
• FDA 21 CFR part 11

What Prior Knowledge is Needed?

It is useful but not essential to have completed the module Introduction to Clinical ResearchThis previous module provides a good overview of the industry and the various stages of clinical research.