Event Detail

Applied GCP Training for Investigational Sites and Sponsor Representatives (Full Programme)
Start Date: 01 Jan 2016
Start Time: 00:00
End Date: 31 Dec 2017
End Time: 00:00
Type: Online
Rank: Introductory
Venue: Online


Dates: 1 month to complete all 3 certificates

Venue: Computer based training (CBT) These are web-based programmes which include narration. A CBT must be completed within a set time frame, in your own time. As the trainer and you are not on-line the same time, this type of event is also know as asynchronous elearning (no live interaction with the instructor).

Access to a CBT requires one computer (with printer and speakers to hear the narration) and one internet connection with login information provided by ARCS. Please see internet requirements below.

Requirements to view online content:
• Flash
Adobe Flash Player 10 or later, and one of these browsers:
Window: Internet Explorer 8 or later, Microsoft Edge (latest version), Google Chrome (latest version), Firefox (latest version)
Mac: Safari 7 or later, Google Chrome (latest version), Firefox (latest version)

• HTML5
Window: Google Chrome (latest version)
Mac: Safari 7 or later, Google Chrome (latest version)
Mobile: Safari in Apple iOS 5 or later, Google Chrome (latest version) in Android OS 4.1 or later


Who Should Attend: 
This programme consists of three GCP certificates of completion. It is applicable to all research stakeholders (including clinical investigators, study coordinators, as well as sponsor representatives). This approach of looking at GCP from the three perspectives ensures that each stakeholder understands their role and obligations under GCP and how these relate to those of the other stakeholders.


Course Overview: 
Applied GCP Training For Investigational Sites And Sponsor Representatives


Certificate 1: Research and GCP Foundations Module 

1.1: Understanding the regulatory environment for clinical trials
•Why we have regulation
•The history of regulations
•An overview of ICH-GCP
•Clinical trial regulation in Australia
•Duration: Up to 60 minutes

Module 1.2: Drug development and trial process
•Type of research
•Drug development - where do clinical trials fit in?
•The clinical trial process
•Trial set up - Recruitment
•Maintenance
•Closure and completion
•GCP through the clinical trial process
•Duration: Up to 60 minutes

Module 1.3: Research roles & responsibilities
•An Introduction
•Who are the research stakeholders
•The role in clinical trial of the:
•Sponsor/Monitor
•Investigator
•Sponsor-Investigator
•Ethics committee
•Duration: Up to 30 minutes

Certificate 2: Stakeholder roles and responsibilities 

Module 2.1: Research roles and responsibilities - clinical trial sponsors
•General sponsor responsibilities including:
•Getting the trial started
•Recruitment
•Managing the trial
•Trial closure
•Sponsor monitoring responsibilities
•Getting the trial started
•Ongoing
•Audits
•Assessment
•Duration: Up to 60 minutes

Module 2.2: Role and responsibilities of a clinical trial investigator
•What is involved in being a clinical investigator including:
•Getting the trial started
•Recruiting patients  
•Manging the ongoing trial  
•Trial closure
•How best to comply with the requirements outlined in GCP
•Duration: Up to 60 minutes

Module 2.3: Roles and Responsibilities of the ethics committee
•GCP requirements and composition
•What is the role of the ethics committee
•Before a trial begins
•Once a trial is approved
•Top tips for working with ethics committees  
•Assessment and Certificate 2 case studies
•Duration: Up to 30 minutes

Certificate 3: Practical Considerations in the conduct of clinical trials 

Module 3.1: The ethical management of participants
•How patients rights and safety are protected in research
•Various stakeholder responsibilities with respect to:
•Ethical review - Recruitment
•Consent
•Ethical guiding principles
•Common consent issues
•Case study and assessment
•Duration: Up to 60 minutes

Module 3.2: Adverse event reporting
•AE Reporting and the life cycle of therapeutic goods
•Definitions and the safety cycle
•Standards for expedited reporting
•Minimum criteria for reporting
•Australian requirements
•Assessment Duration: Up to 30 minutes

Module 3.3: Quality management and clinical trial
•Quality management in clinical trials  
•What are the audits?
•Key questions asked during an audit
•The audit process
•Fraud
•What is it?
•How is it detected?
•How to deal with it?
•Assessment Duration: Up to 30 minutes

Module 3.4: Clinical trial documentation
•What are the clinical trial documents
•The data cycle - Good documentation tips
•Best practices with regards to:
•Source documents
•Electronic records
•Protocol amendments
•FDA study documentation
•Delegation of responsibilities
•Investigational product accountability
•Archiving considerations
•Duration: Up to 60 minutes


Course Highlights: 
Those who successfully complete all 3 certificates will receive a GCP certificate of completion from ARCS Australia. This programme is based on:

•Access to Unapproved Therapeutic Goods
•Clinical Trials in Australia (October 2004)
•National Statement on Ethical Conduct in Human Research (2007)
•Good Clinical Practice (ICH-GCP)
•Australian Code for the Responsible Conduct of Research (2007)

Each module is accompanied by a series of assessment questions and/or case studies which ask students to apply the learning.

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 Those who successfully complete the assessment will receive a GCP certificate of completion from ARCS Australia which is valid for 3 years.


What others have said:
"The ARCS GCP online training course has led me through the research stages from sponsors, investigators and patients, and HRECs. Having the bigger picture, and everyone's roles clearly set out, I can take more initiative my work. I've also got a sense of the particular needs of clinical research. I see how I could develop my role from the general medical admin skills I first brought to it. (The technical support from ARCS was excellent, too.)"


Entry Criteria: 
There are no entry criteria for this computer based training. If you have any questions on your suitability for this course, do not hesitate to call the ARCS Business Office on (02) 8905 0829. Important Registration Information Immediate payment must be made before you will be sent access to the online training. You will have access for 1 month from when you pay for this training to pass and complete the modules.  You will be emailed access details within three business days of your payment being received.


Refunds, Transfers and Cancellations: 
No refunds, transfers or cancellations will be accepted after access to the online training has been granted.


Online Training Fees
ARCS Member - $269.00
Retired/Student Member - $205.00
Non Member - $340.00