Description
This ICH E6 GCP Investigator Site Training meets the Minimum Criteria for ICH GCP Investigator Site Personnel Training identified by TransCelerate BioPharma as necessary to enable mutual recognition of GCP training among trial sponsors. This is clearly stated on the certificate provided on successful completion of the course.
The investigational site has a key role to play in clinical research. This module introduces the clinical trials process and covers the key GCP requirements and responsibilities for investigators and investigational site staff. The module also covers other 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 essential for investigators and investigational site staff working in clinical research and clinical trials, particularly those who are not familiar with the guidelines and regulations they should be following. The course provides certification of the completion of GCP for Investigators and Investigational Site Staff Training.
Course Content
Introduction to Clinical Development/Clinical Research

Objectives of Clinical Research

What is a clinical trial?

Stages of Clinical Research

Generic Products
Background to Clinical Trials Regulation
ICH GCP including R2 (The GCP Addendum)

Overview and principles of ICH GCP

Roles and Responsibilities, with emphasis on investigator responsibilities

Protocol and amendments

Investigators Brochure

Essential Documents
EUROPE

Eudralex Volume 10

EU Clinical Trials Directive

EU GCP Directive

GMP Directive and Annexe 13

EU Guidelines and Recommendations
THE USA

FDA Code of Federal Regulations Title 21

FDA CFR 21 Part 312

FDA 21 CFR part 11
Audit and Inspection
Fraud and Misconduct
What Prior Knowledge is Needed?
No prior knowledge is necessary, this module covers the key aspects investigators and investigational site staff need to be aware of.
Over 10,000 users have completed PharmaSchool Online Modules & Packages. They are globally recognised as providing cost effective, high quality and relevant training and certification to new and existing clinical researchers. The modules have been used in over 50 countries by the full range of clinical research and clinical trial roles.
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