Good Clinical Practice (ICH GCP) 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 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. A  personalised GCP training certificate will be available for download upon successful completion of the course.

Course enrolment is free. Please complete the registration form below to create a student account.

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 Participants
  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

Course Recognition

The GRS GCP course and certificate are compliant with the Mutual Recognition (MR) Program for ICH E6 Good Clinical Practice (GCP) Training developed by the TransCelerate Site Qualification and Training (SQT) Initiative. This enables professional recognition of GCP training within the clinical research industry. Read more about GCP Mutual Recognition here.

The GRS Good Clinical Practice (GCP) Course is recommended by:

NSW Health - Newcastle Research Institute - Genesis Research Services
Good Clinical Practice - Newcastle Research Institute - Genesis Research Services

Course Registration Form

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