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 hours to complete.
Learning Objectives
  1. Introduction to Clinical Trials
  2. GCP in Australia – 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 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.
Access the course
Registration Form
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