The workshop is full of practical coordination tips from people who have been setting up research for years. The workshop is structured so that you will walk away with useful techniques, tools and tips to apply at your centre.
Workshop overview
This workshop for study coordinators has been developed by an Australian advisory board made up of individuals with over 100 years of combined experience in coordinating clinical research at hospital sites. The workshop is full of practical coordination tips from people who have been setting up research for years. The workshop is structured so that you will walk away with useful techniques, tools and tips to apply at your centre.
This ICH E6 GCP Investigator Site Training meets the Minimum Criteria for ICH GCP Investigator Site Personnel Training identified by TransCelerate BioPharma as necessary to enable mutual recognition of GCP training among trial sponsors.
Who should attend
- New coordinators looking for more information
- Individuals in an academic research capacity (including PhD students, staff in pharmacy, laboratories staff etc.) interested in how clinical research is coordinated
- Individuals looking for a toolkit to assist with coordinating research at their hospital/clinic
- Individuals looking to share experience and learn from others
- Those who do not have a clinical trial background and seek to broaden their understanding of the coordinator role.
N.B: This workshop forms part of the certification pathway.
Workshop highlights
Day 1 - Topics include:
- Research Foundations
- Coordination roadmap
- Types of human research, drug development and study design
- Research standards
- Roles and responsibilities
- Protocols, proposals, descriptions
- Submitting your project to HREC
- HREA orientation and tips
- Establishing your regulatory binder
- Participant recruitment planning
Day 2 - Topics include:
- Informed consent
- Participant safety
- Definitions and the safety cycle
- Source documents
- Definitions and the data cycle
- An auditor’s perspective
- Laboratory data
- Drug handling, compliance and accountability
- Delegation of responsibility
- QC & QA in clinical trials
- Demystifying audits
