Investigator and Site Personnel Good Clinical Practice (ICH GCP) Training
Welcome
Welcome to the Investigator and Site Personnel Good Clinical Practice (ICH GCP) online training program.
This course is designed to prepare investigators and research staff for the conduct of clinical trials with human participants. It includes an overview of GCP, the principles of ICH GCP, and investigator responsibilities. Learners will also be introduced to the Australian regulatory environment, and the roles and responsibilities of the sponsor, contract research organisation, and clinical trial monitor.
The course and certificate are compliant with the TransCelerate Site Qualification and Training (SQT) Initiative, reflecting professional recognition for ICH E6 Good Clinical Practice (GCP) Training targeted to investigator site personnel.
The course was written and developed by Dominic Bailey (MClinTRes) and Danielle Santarelli (PhD).
Instructions
Please read the instructions by clicking on the tabs below.
Following these instructions will ensure that your progress is updated correctly and that your certificate displays the correct information.
If you are experiencing any issues with the course, please refer to the Frequently Asked Questions before contacting us.
The course consists of 2 lessons with a total of 16 topics and a final assessment quiz. Each topic consists of one page of learning material. Some topics contain short videos that we recommend you take the time to watch. External links should automatically open in a new tab.
You can revisit topics at any time by clicking on the course title or the lesson title above the progress bar located on the top of any course page.
At the end of each topic, click on the “Mark Complete” button in order to confirm your progress and move on to the next topic. Once you have completed all topics within a lesson, click on “Back to Lesson” and then click on the “Mark Complete” button before moving on to the next lesson.
It is important that you do not skip these steps otherwise your course certificate will not display a completion date.
Note: The complete study guide for this course can be downloaded from either of the Lesson pages (see below under “Course Content”, then look for the Download button under “Learning Materials”).
The GCP assessment quiz consists of 20 randomised questions. The questions consist of both single choice (only 1 correct answer) and multiple choice (more than 1 correct answer possible) items. The type of question is indicated in parentheses ( )’s underneath the question.
You will need to correctly answer at least 16 of the 20 questions (a score of at least 80%) to pass the course.
A results page will load upon finishing the quiz. To review your answers, click on the View Questions button. Correctly answered questions are highlighted green. Incorrectly answered questions are displayed with a red border, with the correct answers displayed in a green border.
There is no time limit. You may attempt the quiz as many times as you need to.
If you have completed all of the course lessons and topics, and received a passing grade on the quiz, a personalised course certificate will be generated.
NOTE: If you have not marked each course topic and lesson as complete, your certificate will not display a completion date. Please go back to each topic and lesson and mark them as complete. You may then re-download your certificate.
To download your certificate, return to this page to find a certificate download button below. You can also download your certificate from the Student Account page.
The certificate will expire after three (3) years from the completion date.
PLEASE NOTE: GCP course certificates will be removed from our website after 2 years. To avoid losing access, be sure to download your certificate and store it in a safe place. We recommend emailing yourself a copy for added security.
***PLEASE NOTE: GCP course certificates will be removed from our website after 2 years. To avoid losing access, be sure to download your certificate and store it in a safe place. We recommend emailing yourself a copy for added security.