Welcome to the Investigator and Site Personnel Good Clinical Practice (ICH GCP) online training program.
The intent of this training program is to define the Minimum Criteria for Good Clinical Practice (GCP) training of investigators and site personnel (based upon ICH E6 R2) to enable the mutual recognition of GCP training within the Australian clinical research industry. To satisfy these Minimum Criteria, the training includes GCP overview, the principles of ICH GCP and investigator responsibilities.
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.
To begin a unit, click the unit title. You will be taken to a content page, which you should read through carefully. Some units contain short videos that we recommend you take the time to watch. External links should automatically open in a new tab.
You can view and complete the course units in any order, however, we recommend that you progress through the units in the default order. At the end of each unit page, you will need to click the "Mark as Completed" button in order to confirm your progress.
You can revisit completed units at any time by returning to this page via the Genesis site menu at the top of the page, or by using the Course Progress widget located on the right side of each unit page. Click on the plus (+) sign to expand a module and view the complete list of units. Completed units will be coloured green. To move onto the next unit or revisit the previous unit, click the "Next Unit" or "Previous Unit" buttons located at the bottom of the unit page.
Assessment & Certificate
Unit 13 (Module 2) is the GCP assessment quiz. You will need to correctly answer at least 16 of the 20 questions (a score of at least 80%) to pass the course. The quiz may be reattempted.
After successful completion of the assessment quiz, you will receive an email with your result.
The course administrator will review your result and issue you with a personalised GCP training certificate via email. Please be aware that it may take up to 2 business days to receive your certificate.
|Module 1||Investigator and Site Personnel Good Clinical Practice - Introduction|
|Unit 1||Introduction to Clinical Trials|
|Unit 2||Good Clinical Practice – An Overview|
|Unit 3||The Australian Regulatory Environment|
|Unit 4||Roles and Responsibilities|
|Module 2||Investigator and Site Personnel Good Clinical Practice - The Principles of ICH GCP|
|Unit 1||Investigator Qualifications and Agreements|
|Unit 3||Medical Care of Trial Participants|
|Unit 4||Communication with HREC|
|Unit 5||Compliance with Protocol|
|Unit 6||Investigational Products|
|Unit 7||Randomization Procedures and Unblinding|
|Unit 8||Informed Consent of Trial Participants|
|Unit 9||Records and Reports|
|Unit 10||Progress Reporting / Final Reports|
|Unit 11||Safety Reporting|
|Unit 12||Premature Termination or Suspension of Trial|
|Unit 13||GCP Assessment|
|Unit 14||GCP Course Evaluation Survey|