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:
鈥nderstand the principles of GCP
鈥e able to define the different phases of clinical research
鈥nderstand ethical and regulatory requirements of clinical trials
鈥e able to describe the order of events in setting up and running a clinical trial
鈥e able to list and understand the purpose of the various documents required for a clinical trial
鈥ppreciate the interplay between different functions within the sponsoring company when running a clinical trial
鈥now the importance of safety reporting within clinical trials
鈥e 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 鈥淕ood Clinical Practice鈥� 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:
鈥nderstand the principles of GCP
鈥e able to define the different phases of clinical research
鈥nderstand ethical and regulatory requirements of clinical trials
鈥e able to describe the order of events in setting up and running a clinical trial
鈥e able to list and understand the purpose of the various documents required for a clinical trial
鈥ppreciate the interplay between different functions within the sponsoring company when running a clinical trial
鈥now the importance of safety reporting within clinical trials
鈥e 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 鈥淕ood Clinical Practice鈥� course.
