By the end of the course you will:
鈥nderstand the principles of GCP
鈥efine the different phases of clinical research
鈥nderstand ethical and regulatory requirements of clinical trials
鈥escribe the order of events in setting up and running a clinical trial
鈥ist and understand the purpose of the various documents required for a clinical trial
鈥nderstand the interplay between different functions within the sponsoring company when running a clinical trial
鈥ppreciate the importance of safety reporting within clinical trials
鈥efine 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.
鈥nderstand the principles of GCP
鈥efine the different phases of clinical research
鈥nderstand ethical and regulatory requirements of clinical trials
鈥escribe the order of events in setting up and running a clinical trial
鈥ist and understand the purpose of the various documents required for a clinical trial
鈥nderstand the interplay between different functions within the sponsoring company when running a clinical trial
鈥ppreciate the importance of safety reporting within clinical trials
鈥efine 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.
