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 course 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 course 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.
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.
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
Anna Megalakakis
Anna is the Senior Training Manager at ARCS Australia.
Continuing Professional Development (CPD) points
Upon completion of this workshop, attendees will receive 14 CPD points.
ARCS CPD points meet the requirements of the Nursing and Midwifery Board of Australia (NMBA).
This is an entry level/introductory workshop. There are no entry criteria for this course. If you have any questions on your suitability for this workshop, please contact the ARCS office on (02) 8905 0829.
Course fees (inc. GST):
Early bird - until 29 May
ARCS member - $1,005
Non-member - $1,660.00
Government/Institutional - (Please contact the ARCS office on (02) 8905 0829)
Standard - from 30 May
ARCS Member - $1,330.00
Non Member - $2,145.00
Government/Institutional - (Please contact the ARCS office on (02) 8905 0829)
Registration terms and conditions
This course runs for two full days from 09:00-17:00
Attendee requirements:
Computer/laptop connected to power
Good internet access (1Mbps or better – broadband recommended)
A charged mobile phone and headphones (if using your phone for audio)
Phone charger – given the event goes all day, you will need a way of charging your phone
Headphones for computer audio (if using computer audio)
A quiet room/space
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