This eLearning course includes the new ICH-GCP E6(R2) updates and is essential for all clinical researchers. 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.
GCP Training Timeframe: Generally speaking, site investigators complete GCP training within three (3) years of the start of a new study. Investigators are not expected to retake GCP training during the study (unless required by local regulation or at the discretion of the sponsor). The ARCS programs include all updates to local regulations and guidelines (above and beyond the requirements set out by Transcelerate and ICH-GCP). ARCS strongly recommends site investigators assess the need to undertake refresher training at the start of all new studies.
ARCS in the past (before Jan 2019) has issued expiration dates on our GCP certificates. Sponsors may decide to recognise a certificate regardless of an expiration date being present on a certificate.
The full program comprises certificates 1, 2 and 3
Certificate 1: Research and GCP Foundations
Module 1.1: Understanding the regulatory environment for clinical trials
* Why we have regulations
* The history of regulations
* An overview of ICH-GCP
* Clinical trial regulations 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
* 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
- 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
- Managing 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
This program 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.
Highlights:
Those who successfully complete all 3 certificates will receive a GCP certificate of completion from ARCS Australia. This program is based on:
Australian Clinical trial handbook. Guidance on conducting clinical trials in Australia using unapproved therapeutic goods (current version)
National Statement on Ethical Conduct in Human Research (current version)
Good Clinical Practice (ICH-GCP) (current version)
Australian Code for the Responsible Conduct of Research (current version)
Each module is accompanied by a series of online assessment questions and/or case studies which ask students to apply the learning.
Computer-based training (CBT):
These are web-based programs which include narration. CBT must be completed within a set timeframe, at a time suitable to you. You are not on-line at the same time as the trainer. This type of event is known as asynchronous e-learning (no live interaction with the instructor).
Requirements to view online content:
Access to a CBT requires one computer (with printer and speakers to hear the narration), an internet connection and the login information and link provided by ARCS.
Flash Player 6.0.79 or later. Download the latest version here.
Access will be granted from the day payment is received. You will be given one month to complete the program.
Entry criteria:
There are no entry criteria for this computer based training. If you have any questions on your suitability for this workshop, do not hesitate to call the ARCS Business Office (02) 8905 0829. Payment must be made before you will be sent access to the online training.
Online training fees (incl. GST):
ARCS Member - $269.00
Non-member - $340.00
Access to training provided first business day after payment is received.
Click here for the terms and conditions
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