Welcome to the Good Clinical Practice (ICH GCP (R3)) Online Training Course developed by Genesis Research Services.
This course is designed to prepare clinical research personnel for the ethical conduct of clinical trials. It covers the latest version of the ICH GCP guideline (ICH E6(R3)), focusing on the principles of Good Clinical Practice and the roles and responsibilities of the investigator.
The course satisfies the Minimum Criteria for Good Clinical Practice (GCP) training of investigators and site personnel (based upon ICH E6(R3)) as defined by TransCelerate BioPharma. This enables mutual recognition of GCP training and certification within the clinical research industry.
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 five lessons and a final assessment quiz. Each lesson contains a series of topics and a mini quiz.
At the end of each topic, you must click on the “Mark Complete” button to confirm your progress and move on to the next topic.
Before progressing to the final assessment quiz, please make sure that all topics, mini quizzes, and lessons are marked as complete. It is important that you do not skip these steps otherwise your course certificate will not display a completion date.
You can revisit topics at any time by clicking on the course title or lesson title above the progress bar located on the top of any course page.
After completing this training, you should be able to:
u Explain the importance of Good Clinical Practice (GCP) and the need for GCP training for all individuals involved in research with human participants.
u Identify and reference the principles of ICH GCP (R3).
u Outline the key roles and responsibilities of sponsors, investigators, and other individuals and parties involved in the conduct of clinical trials.
u Summarise the key responsibilities of investigators, as outlined in Annex 1, Section 2 of the ICH E6(R3) Guideline.
u Describe the informed consent process.
u Provide examples of key information to be communicated during the informed consent discussion and included in the informed consent materials.
u Outline the requirements for safety reporting in clinical trials.
u Identify essential records required for the conduct of a clinical trial.
u Recall the elements of good source documentation.
u Describe key concepts in trial design, conduct, and management, including quality by design, risk proportionate approaches, and data governance.
Mini Quizzes
At the end of each lesson is a mini quiz consisting of 2-3 questions. The mini quizzes serve as practice activities. You must answer at least one question correctly to complete the lesson.
Once you have passed all mini quizzes, you may attempt the final assessment quiz.
Final Assessment Quiz
The final assessment quiz will be available to attempt once all course lessons, topics, and mini quizzes have been marked as complete. The final assessment quiz consists of 20 randomised questions. You will need to correctly answer at least 16 of the 20 questions (a score of at least 80%) to pass the course.
There is no time limit to the quizzes. You may attempt the quizzes as many times as you need to.
Quizzes consist of the following types of questions and activities:
u Single choice – only one correct answer.
u Multiple choice – more than one correct answer possible.
u Ordering – place the items in the correct order.
u Matching (sorting) – match the sort elements to their associated items.
u Fill in the blank – type the correct answer in the empty space.
Once you have completed all lessons and topics and received a passing grade on the assessment quiz, a personalised course certificate will be generated.
You may download your certificate from the following pages:
NOTE: To ensure your certificate displays a completion date, you must mark each course topic and lesson as complete. You can redownload your certificate after doing this.
PLEASE NOTE: GCP course certificates will be removed from our website after 1 year. To avoid losing your certificate, please download it and save it in a safe place.
© Genesis Research Services Pty Ltd, 2025. All rights reserved.
Genesis Research Services either owns, or is licensed to use, all materials included in this course. Materials created by Genesis Research Services are protected under Australian copyright law. Copyright for any third-party content remains with the original owner.
This course is provided to registered users for the sole purpose of completing GCP training. It must not be copied, reproduced, modified, adapted, or redistributed for any other purpose without prior written consent from Genesis Research Services.
For enquiries, please contact: reception@genesisresearchservices.com
Note: The complete study guide and additional resources for this course can be downloaded from any of the Lesson pages under “Learning Materials”.
