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. The content is the same as the ICH GCP Certificate with the addition of US and EU Guidelines.
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. |
