ARCS can deliver in-house training for your team so you can maximise your training budget, save money on individual employee travel and most of all save time out of the office. ARCS in-house training is a cost-effective option that offers the convenience of learning from highly qualified and professional experts from the MTP sector at your office.
Conducting Clinical Research – Essential GCP Training for New Coordinators and Researchers (CCR1)
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.
Note: 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
Workshop overview:
Do you want to be more confident when starting up your next research project or when dealing with quality and GCP issues at your research site? Would you like to develop skills to coordinate more complex projects? This workshop will explore tools, strategies and best practice for a range of processes essential to the effective starting up and running of single and multi-centre research sites.
You will be guided through practical issues such as study feasibility assessments, resourcing, budget management and the multi-centred ethics submission process as well as quality systems, audit-readiness and communications to strengthen relationships.
This workshop seeks to build on the topics covered during the first workshop titled ’Conducting Clinical Research – Essential GCP training for New Coordinators and Researchers’ by helping attendees apply what they have learnt and broaden their understanding of effective investigational site management. To ensure a quality program, ARCS has developed this workshop in consultation with an Australian advisory board. Collectively, the individuals on the board have over 100 years’ experience in managing investigational sites.
Who should attend?
This two-day workshop is intended for experienced study site staff; including investigators, and study coordinators. There is a basic assumed knowledge of terminology and processes as outlined in ’Conducting Clinical Research – Essential GCP training for New Coordinators and Researchers.’ This workshop is for study site staff from hospitals as well as academic research. Attendees will value the opportunity to discuss and share experiences regarding successful site management and practical application and problem solving of ethical issues in clinical research.
Workshop highlights:
Assess the feasibility of a study at your site
Plan study resources and responsibilities for a study; including staff, equipment and facilities
Devise, negotiate and manage a study budget
Discuss the roles and responsibilities of the lead and local site in multi-centre research
Research standards overview
Having the right quality systems, such as SOPs, in place for your study site
Maintain your site as ’inspection/audit ready’
Managing GCP issues more effectively
What is effective communication?
Identify your areas of influence to better manage your Site - CRO/Sponsor Relationships
Workshop overview:
Do you have questions about the role of the Clinical Research Associate (CRA) in clinical research? Do you need a good solid foundation in GCP? This introductory workshop covers the current regulatory environment, drug development process and guides CRAs through their role in conducting studies in Australia and New Zealand. This workshop will give you a solid introduction to the major areas that need to be considered when conducting clinical research. It is essential training for a new CRA.
Who should attend?
The workshop is aimed at:
New CRAs who need more information about the typical roles, tasks and responsibilities of CRAs
Site personnel with experience in clinical research, interested in a better understanding of the CRA's role
Those that do not have a clinical trial background who are seeking to broaden their understanding of the role of the CRA
Workshop highlights:
Day 1
Therapeutic goods and their regulation
Access to unapproved therapeutic goods
The drug development process
The big picture
The clinical trial process
GCP (ICH, WHO and others)
Declaration of Helsinki
Protocol Review
Day 2
Getting a study started:
Site selection
Ethical review of research and Research Governance
Monitoring
The whole story
The role of the CRA
Monitoring - what is it?
Useful tools, checklists & forms
Data clarification
Hands on experience!
SDV exercise
Study Closure, Audits and Inspections
Workshop overview:
This is an intermediate workshop that seeks to build on topics covered during the first workshop titled “Clinical Research Associate (CRA): An Introduction" (previously "Essential and Practical GCP Training for New Monitors and CRAs”). It will help improve your site management skills by starting with a high level review of the ABCs of project management. The workshop then covers a number of challenges and strategies to effectively manage risk within key clinical trial processes and to assist you to get the most from your trial sites.
Who should attend?
Individuals with 12 months' or more experience implementing clinical research looking to develop better site management skills
Experienced monitors looking to move into more senior positions
Individuals looking for a forum to discuss how different people tackle typical problems encountered when implementing clinical trials
Workshop highlights:
Day 1
Review of research standards
The ABCs of clinical trial project management
The role of the project manager
The project trade-offs
Ten critical considerations when planning your next clinical trial
Project reporting
Project risk
How to manage risk via effective:
Feasibility assessments
Site selection
Informed consent process
Day 2
How to manage risk via effective (continued):
Recruitment strategies and contingencies
Investigational product (IP) management
Supporting your sites with effective communication and motivating the team
Quality Management
Managing GCP issues more effectively
Fraud and misconduct
Common audit issues
Please contact arcs for additional information regarding in house trainings. We are happy to tailor content to your specific needs*
Better job skills
Help your team develop skills relevant to their roles and responsibilities. Our experts will come to your workplace to deliver the workshops, we’ll create customised training programs tailored to your business needs.
Maintain confidentiality
Maintain and protect confidentiality of your systems and data ensuring the right people learn about your proprietary information, business plans and operating methods.
Higher information retention
Group interaction reinforces learning and professional growth. Your organisation will benefit from increased collaboration built on interactive learning.
Better ROI
Boost the return on your training investment even more by spending less on travel and reducing downtime.
Contact us on arcs@arcs.com.au to find out more about a tailored ARCS in-house training solution.
.png){kind=logo}
.png)
%20(2).jpg)
