This course will introduce research support staff to:
- The development process of a new investigation product
- The different clinical trials phases and common trial design terminology
- The main players involved in clinical trials
- High level overview of the steps involved in running and managing clinical trials
This course will introduce research support staff to:
- Different stages involved in running clinical trials
- The role of sponsor and site in the feasibility and start-up stage
- The clinical trial essential documents required to be retained at the site
- The process of enrolling participants in a clinical trial, including informed consent and required documentation
- The process of clinical trial data management
- The requirements for study closure and archiving
The course is also included in Trials Essentials for Research Support Team in a series of 6 courses with a package certificate
This course will introduce research support staff to:
- The Australian regulatory requirements governing clinical trials
- The impact of overseas regulatory agencies on trials conducted in Australia
- The roles of Human Research Ethics committees and Research Governance Offices in reviewing clinical trials in Australia
- The Australian research ethical values and criticise the ethical conduct of clinical trials
- the Australian national legislation impacting the conduct of a clinical trial in Australia
This course will introduce research support staff to:
- The different application forms used in submitting a clinical trial to ethics and governance
- The research application and sites coordination process in Australia
- The documents required for ethics and governance review and approval
- The post-authorisation reports required to be submitted during the lifetime of a clinical trial
This course will introduce research support staff to:
- The different safety terminologies used in clinical trials
- The safety reporting responsibilities of sponsors and principal investigators
- The safety reporting requirements for investigational products in accordance with the NHMRC guidelines 2016
This course will introduce research support staff to:
- The difference between monitoring, auditing and inspection
- The role of monitors (CRAs) in clinical trials
- Different monitoring approaches in a clinical trial
- The auditing process and its relation to the quality management of a clinical trial
- Concepts of root cause analysis and corrective and preventive actions for trials audit/inspection findings
- Guiding tools and checklists to prepare for site audit/inspection visits
This Course will introduce investigators to:
- The Australian regulatory requirements governing clinical trials
- The impact of overseas regulatory agencies on trials conducted in Australia
- The roles of Human Research Ethics committees and Research Governance Offices in reviewing clinical trials in Australia
- The Australian research ethical values and the ethical conduct of clinical trials
- The Australian national legislation impacting the conduct of a clinical trial in Austral
- The different application forms used in submitting a clinical trial to ethics and governance
- The research application and sites coordination process in Australia
The course is also included in Trials Essentials for Investigators in a series of 5 courses with a package certificate
This course will introduce investigators to:
- Site enablers to run effective trials
- Core components of trial feasibility assessment
- Standard of Care (SOC) and Above SOC trial procedures and the impact on trial budgeting
- Process, components and responsibilities of trial budgeting and contracting
- Core elements of study start-up & initiation
The course is also included in Trials Essentials for Investigators in a series of 5 courses with a package certificate
This course will introduce investigators to:
- Safety reporting requirements for investigational products in accordance with: NHMRC EH59 guidance on safety monitoring and reporting in clinical trials involving therapeutic goods 2016
- The safety reporting responsibilities of sponsors and principal investigators in therapeutic goods clinical trials
- PI oversight in safety management of their trial participants
The course is also included in Trials Essentials for Investigators in a series of 5 courses with a package certificate
This course will introduce investigators to:
- PI responsibility in overseeing protocol compliance
- The reporting responsibilities of PI & sponsor when serious breaches occur in trials
- Protocol deviations and serious breaches in trials
The course is also included in Trials Essentials for Investigators in a series of 5 courses with a package certificate
This course will introduce investigators to:
- Roles and responsibilities of PI’s research support team
- Importance of delegation of trained staff
- PI oversight during the trial management
- Role of PI in recruitment and requirements of informed consent
- Difference between monitoring, auditing and inspection
- The auditing process and PI oversight
The course is also included in Trials Essentials for Investigators in a series of 5 courses with a package certificate
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