Good Clinical Practice (ICH GCP) Course
About the Course
The GRS Good Clinical Practice (GCP) Course is designed to prepare both investigators and research staff for the conduct of clinical trials with human participants. 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 an overview of GCP, the principles of ICH-GCP, and investigator responsibilities.
The course is self-paced and takes approximately 2 – 4 hours to complete. Course enrolment is free. Please complete the registration form below to create a student account and enrol.
Learning Objectives
1. Introduction to Clinical Trials
2. Good Clinical Practice – An Overview
3. The Australian Regulatory Environment
4. Roles and Responsibilities
5. Investigator Qualifications and Agreements
6. Resourcing
7. Medical Care of Trial Subjects
8. Communication with HREC
9. Compliance with Protocol
10. Investigational Products
11. Randomization Procedures and Unblinding
12. Informed Consent of Trial Participants
13. Records and Reports
14. Progress Reporting and Final Reports
15. Safety Reporting
16. Premature Termination or Suspension of Trial
Certification
A GRS course administrator will issue a personalised GCP training certificate upon completion of the training course.
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.
Confirmation of registration will be emailed to you.
Once registered, you may enrol into this course by logging into your User Account and navigating to the Account > Courses page.