1. INTRODUCTION

GCP is not one set of safety standards, issued by one regulatory agency, or found in one document. Rather, the GCP standard has evolved over time, is recognised by regulatory agencies around the world, and includes the procedures by which drugs and devices are approved for human use.

This GCP and basic ethics training package for investigators contains 8 units. It is not necessary to take the Quiz if you have recently completed a GCP training course. However, we would recommend that you would browse the course to re-familiarise yourself with pertinent topics. Otherwise, to receive the training certificate, passing the GCP quiz with a score of 75% or higher is a mandatory requirement. Upon successful completion of the GCP quiz and submission of the 'Certification of Own Work', you will be provided with a 'Trial Coordinating Centre GCP training certificate' (Certificate of completion).

THE FULL TRAINING PACKAGE WILL PROVIDE YOU WITH THE FOLLOWING (follow the links on the buttons below):

1 Identify the reasons why Good Clinical Practice is required in clinical research

2 Identify the ethical principles which govern clinical research

3 Define the regulations and guidelines applicable to clinical research

4 Describe Investigator's responsibilities in conducting clinical research

5 Describe the informed consent process and documentation requirements; identify exceptions to the general rules and know the proper procedures in such exceptional situations

6 Prepare for successful monitoring visits and site audits by sponsors and regulatory bodies

7 Describe the ethical considerations in planning, designing, conducting and reporting clinical trials

8 Specify which organisation / regulatory agency is responsible for overseeing the conduct of clinical trials in the participant's own county.

9 Describe clinical trial close-out procedures and legal requirements