Course Scope
This course provides an introduction to the clinical trials process and the requirements of Good Clinical Practice (GCP).
The course will walk through the clinical trials process from start to finish and focus on the ethical/regulatory/documentation requirements as well as the practical aspects of clinical trials. Practical exercises will help bring into focus the logistics involved in running a clinical trial.
Overview:
At the end of the course you will:
•Understand the principles of GCP
•Be able to define the different phases of clinical research
•Understand ethical and regulatory requirements of clinical trials
•Be able to describe the order of events in setting up and running a clinical trial
•Be able to list and understand the purpose of the various documents required for a clinical trial
•Appreciate the interplay between different functions within the sponsoring company when running a clinical trial
•Know the importance of safety reporting within clinical trials
•Be able to define a Serious Adverse Event and a SUSAR
Who should attend:
The course is suitable for people who want a basic introduction to clinical trials and GCP. This may be people who work in a GMP/hospital environment with Investigational Medicinal Products who want a greater understanding of the clinical trials process and documentation requirements. The course is also suitable for those who are about to start a role in clinical research but have not had any formal training. This course provides an introduction to GCP, a more in-depth look at GCP is provided in the “Good Clinical Practice” course.
This course provides an introduction to the clinical trials process and the requirements of Good Clinical Practice (GCP).
The course will walk through the clinical trials process from start to finish and focus on the ethical/regulatory/documentation requirements as well as the practical aspects of clinical trials. Practical exercises will help bring into focus the logistics involved in running a clinical trial.
Overview:
At the end of the course you will:
•Understand the principles of GCP
•Be able to define the different phases of clinical research
•Understand ethical and regulatory requirements of clinical trials
•Be able to describe the order of events in setting up and running a clinical trial
•Be able to list and understand the purpose of the various documents required for a clinical trial
•Appreciate the interplay between different functions within the sponsoring company when running a clinical trial
•Know the importance of safety reporting within clinical trials
•Be able to define a Serious Adverse Event and a SUSAR
Who should attend:
The course is suitable for people who want a basic introduction to clinical trials and GCP. This may be people who work in a GMP/hospital environment with Investigational Medicinal Products who want a greater understanding of the clinical trials process and documentation requirements. The course is also suitable for those who are about to start a role in clinical research but have not had any formal training. This course provides an introduction to GCP, a more in-depth look at GCP is provided in the “Good Clinical Practice” course.
