This TransCelerate recognised refresher GCP E6R3 course provides a focused update on the revised International Council for Harmonisation Good Clinical Practice (ICH-GCP) guidelines, equipping clinical research professionals with the knowledge to integrate the E6(R3) requirements into daily practice.
By the end of this course, you will have the practical understanding needed to apply the revised 11 GCP principles, maintain compliance, and strengthen oversight and accountability in clinical research operations.
Target Audience: This training is focused on Research Investigator and Site Personnel in Australia.
This course is mutually recognised and listed by TransCelerate as meeting the minimum requirements of ICH E6 (R3) GCP.
Target Audience: Investigators, research support staff, research office staff
This course will introduce you to:
- What is plain language
- The National Statement requirements when writing PICF
- Participants needs
- Principles of plain language writing
- Writing tips for PICF
Target audience: Investigators, Research Nurses/Coordinators, Clinical Trial Assistants
This module includes :
This module is also included in the comprehensive package: Research Ethics and Governance Process.
Target audience: Investigators, Research Nurses/Coordinators, Clinical Trial Assistants
This module includes :
- How to submit an Ethics Application
- HREA
- VSM
- SSA
This module is also included in the comprehensive package: Research Ethics and Governance Process.
Target audience: Investigators, Research Nurses/Coordinators, Clinical Trial Assistants
This module includes :
- Post approval reporting requirements, including routine and non-routine
reports
This module is also included in the comprehensive package: Research Ethics and Governance Process.
This short course will assist you in conducting your research with integrity and complying with the Code principles. The course topics follow the research lifecycle, starting from peer review and ethics approval, and ending with publications and authorship.
- Target Audience: All researchers who conduct, or assist with the conduct of, research.
- Expected time for completion: 30 min
This course is a guide on how to get started in your new role in clinical trials and thrive, not just survive.
This course should be used in conjunction with other courses, and resources available on A-CTEC and we will provide suggestions on these resources throughout the course.
Target Audience:
- Individuals new to Clinical Trials and Clinical Research coordination
- Staff experienced in Clinical Research transitioning from non-clinical trial programs to coordinating their first clinical trials
- Senior staff and managers for guidance on how to orientate and mentor a new staff member
Target audience: Data managers, investigators, study coordinators, unit managers, quality/project managers, trial statisticians
This course includes :
- Data management overview and lifecycle
- Data privacy Regulations
- Data management plan
- Designing data collection instruments
- Data validation plan and tracked changes
- Data registries as source of data for clinical trials
Target audience: Data managers, investigators, study coordinators, unit managers, quality/project managers, trial statisticians
This course includes :
- Data management overview and lifecycle
- Handling externally collected data
- Data metrics reporting
- Surveilling data quality
- Data storage and sharing
Targeted audience: Research Support Staff, Investigators, supporting departments
Course Objectives:
- Define and differentiate clinical trials from other medical research studies
- Describe the different clinical trial phases
- Recognise the purpose of trial protocol
- Identify the main elements to include in a trial protocol
- Navigate the trial protocol based on your role
- Conduct effective feasibility of the trial protocol
- Explore the different risks associated with a trial protocol
- Implement protocol risk assessment before conducting a trial