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.
Topics covered in this program include:
* ICH-GCP introduction and overview
* Underpinning knowledge for clinical investigators
* Getting the trial started & HREC obligations
* Participant management, including recruitment, AE reporting, consent
* Clinical trial documentation (including Source & Essential)
* Investigational product accountability
* Delegation of responsibilities
* Managing the ongoing trial
* Trial closure
* Archiving considerations
* Assessment
* Duration Up to 60 minutes
Entry criteria
You must have completed a full GCP training course by a training provider who has attested it meets the criteria for mutual recognition set out by TransCelerate Biopharma*. GCP courses at ARCS underwent a major update (effective 19Jul2017) with the adoption of ICH-GCP E6(R2). Individuals who completed GCP training before this date should complete one of the full GCP courses being offered by ARCS Australia. If you have any questions about this requirement or your suitability of this course, do not hesitate to call the ARCS Business Office (02) 8905 0829.
* You will be required to provide proof of this certification.
Who should attend?
This program is applicable for investigational trial sites. It is designed as a refresher for those who have already completed relevant GCP training offered by ARCS or have completed equivalent training.
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 online 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.
Workshop fees (incl. GST)
ARCS Members who hold a current TransCelerate recognised GCP certificate - FREE
Non-members who hold a current TransCelerate recognised GCP certificate - $119.00
N.B: Once you have paid for the course you will be given access.
Click here for the terms and conditions
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