Description
There are a wide range of guidelines and regulations in clinical research. This module is designed for those individuals who require a documented knowledge of ICH GCP. The Course Manual guides you through ICH GCP in preparation for the examination. Successful completion (pass mark is 60%) of the exam will earn you an ICH GCP Certification. The manual and the examination are all included within the one price.
Who is the Module Designed For?
The course and certification is for anyone who needs ICH GCP Certification for their job role or prospective career. The content is the same as the GCP and Essential Guidelines Module with the exception of US and EU Guidelines not being included in this.
Course Content
Background
 History of Clinical Trial Legislation
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
Examination and Certification |
