Event Detail

ARCS GCP Refresher Training for Investigational Sites
Start Date: 01 Jan 2016
Start Time: 00:00
End Date: 30 Dec 2017
End Time: 00:00
Type: Online
Rank: Introductory
Venue: Online


Dates: 2 weeks to complete

Venue: Computer based training (CBT)

Duration: Up to 30 minutes

Computer based training (CBT).  These are web-based programs which include narration. A CBT must be completed within a set timeframe, in your own time. As the trainer and you are not on-line the same time, this type of event is also known 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.


Technical Requirements:

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 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.


Course Overview:
Topics covered in this programme 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

Course Highlights: 

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.


Entry Criteria: 

To be eligible to complete this course, you must have completed relevant GCP training offered by ARCS, or have completed equivalent training (please send in your training certificate to This email address is being protected from spambots. You need JavaScript enabled to view it.).  If you have any questions on your suitability for this course, do not hesitate contact us at This email address is being protected from spambots. You need JavaScript enabled to view it.


Important 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 typically be given access within 24 hours of your payment being received. Please contact This email address is being protected from spambots. You need JavaScript enabled to view it.  for quotes for bulk purchase.


Refunds, Transfers and Cancellations:

No refunds, transfers or cancellations will be accepted after access to the online training has been granted.


Pricing:

Members who have completed relevant ARCS GCP training - FREE*

Members who have completed equivalent non-ARCS GCP training - $89**

Non-members/NFPs who have completed relevant ARCS GCP training - $99*

Non-members/NFPs who have completed equivalent non-ARCS GCP training -  $119**

*Please contact This email address is being protected from spambots. You need JavaScript enabled to view it. before registering

**Before registering please send a pdf of your past GCP training certificate to This email address is being protected from spambots. You need JavaScript enabled to view it.