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.
Introduction to Clinical Trials
GCP in Australia – An Overview
The Australian Regulatory Environment
Roles and Responsibilities
Investigator Qualifications and Agreements
Medical Care of Trial Subjects
Communication with HREC
Compliance with Protocol
Randomization Procedures and Unblinding
Informed Consent of Trial Participants
Records and Reports
Progress Reporting and Final Reports
Premature Termination or Suspension of Trial
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.