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.
Introduction to Clinical Development/Clinical Research
Objectives of Clinical Research
What is a clinical trial?
Stages of Clinical Research
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
Eudralex Volume 10
EU Clinical Trials Directive
EU GCP Directive
GMP Directive and Annexe 13
EU Guidelines and Recommendations
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.
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