Course Scope
This course provides an introduction to the clinical trial process and the requirements of Good Clinical Practice GCP. The course will cover each section of ICH-GCP so that participants become familiar with all the guidance. The practical requirements around running a trial to GCP standard will also be covered.
Overview:
At the end of the course you will:
•Understand the principles of GCP
•Be able to define the responsibilities of each party involved in a clinical trial
•Understand ethical issues surrounding informed consent
•Be familiar with each section of ICH-GCP and its contents
•Be able to list and understand the purpose of the various documents required for a clinical trial
•Be able to evaluate your own practice to determine GCP compliance
Who should attend:
The course is suitable for people who have recently started working in clinical trials to ICH-GCP standards. This may be from a sponsor company/sponsor representative e.g. clinical trial leader, study monitor; an investigative site e.g. study physician, study nurse, study coordinator; or review body e.g. hospital research and development committee. The course is also suitable for those who have been previously trained in GCP requiring a refresher.
This course provides an introduction to the clinical trial process and the requirements of Good Clinical Practice GCP. The course will cover each section of ICH-GCP so that participants become familiar with all the guidance. The practical requirements around running a trial to GCP standard will also be covered.
Overview:
At the end of the course you will:
•Understand the principles of GCP
•Be able to define the responsibilities of each party involved in a clinical trial
•Understand ethical issues surrounding informed consent
•Be familiar with each section of ICH-GCP and its contents
•Be able to list and understand the purpose of the various documents required for a clinical trial
•Be able to evaluate your own practice to determine GCP compliance
Who should attend:
The course is suitable for people who have recently started working in clinical trials to ICH-GCP standards. This may be from a sponsor company/sponsor representative e.g. clinical trial leader, study monitor; an investigative site e.g. study physician, study nurse, study coordinator; or review body e.g. hospital research and development committee. The course is also suitable for those who have been previously trained in GCP requiring a refresher.
