Description
The Genesis Research Services Good Clinical Practice (ICH GCP) Training Course is designed to prepare investigators and research staff for the conduct of clinical trials with human participants.
The ICH Good Clinical Practice (GCP) Guideline (ICH E6 R2) is a unified, globally recognised, ethical, scientific, and quality standard for conducting clinical trials. It sets the responsibilities and expectations of sponsors, investigators, and all other professionals involved in designing, conducting, monitoring, recording, and reporting of clinical trials. Complying with the guideline helps to ensure that the rights, safety, and well-being of participants are protected, and that the trial data and results are reliable.
This course satisfies the Minimum Criteria for Good Clinical Practice (GCP) training of investigators and site personnel (based upon ICH E6 R2) as defined by TransCelerate. To satisfy these criteria, the course includes an overview of GCP, the principles of ICH GCP, and investigator responsibilities. Additionally, our course provides an overview of the Australian regulatory environment, and the roles and responsibilities of the sponsor, contract research organisation, and clinical trial monitor.
This is an online, self-paced course consisting of 2 lessons and a final assessment quiz. The course covers a total of 16 learning objectives (topics) and takes approximately 2 – 4 hours to complete.
Access to a complete (71 page) downloadable study guide is provided to course users.
A personalised GCP training certificate will be available for download upon successful completion of the course lessons and assessment quiz.
Learning Objectives
- Introduction to Clinical Trials
- Good Clinical Practice – An Overview
- The Australian Regulatory Environment
- Roles and Responsibilities
- Investigator Qualifications and Agreements
- Resourcing
- Medical Care of Trial Participants
- Communication with HREC
- Compliance with Protocol
- Investigational Products
- Randomization Procedures and Unblinding
- Informed Consent of Trial Participants
- Records and Reports
- Progress Reporting and Final Reports
- Safety Reporting
- Premature Termination or Suspension of Trial
Course Recognition
The Genesis Research Services Good Clinical Practice (ICH GCP) Training Course and certificate are compliant with the Mutual Recognition (MR) Program for ICH E6 (R2) Good Clinical Practice (GCP) Training developed by the TransCelerate Site Qualification and Training (SQT) Initiative. This enables professional recognition of GCP training and certification within the clinical research industry. Read more about GCP Mutual Recognition here.
Our Good Clinical Practice (ICH GCP) Training Course is recommended by: