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Good Clinical Practice (GCP) is a standard for the design, conduct, performance, monitoring, auditing, recording, analysis, and reporting of clinical trials or studies. In 1997, the Food and Drug Administration (FDA) endorsed the Good Clinical Practice (GCP) guidelines developed by the International Conference on Harmonization (ICH).
Infonetica's ICH GCP online course complies with FDA requirements and delivers an up-to-date and comprehensive guide to the basic principles of ICH Good Clinical Practice.
Originally written by Dr Isaac John, Assistant Director of Research and Development at Ashford and St Peter's Hospitals NHS Trust, the course is endorsed by Royal Holloway, University of London. Our US GCP course was designed by Dr. Laura Brown to comply with FDA requirements. She is currently the Course Director, MSc Clinical Research, Cardiff University, UK.
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The online GCP course is aimed at anyone requiring a thorough understanding of the key areas critical to ICH Good Clinical Practice and is also suitable for those looking for a refresher course to update previous GCP training. The course is also ideal for organizations wishing to purchase multiple licenses for their employees. A nominated administrator within the organization is able to control the allocation of licenses and track user progress via a comprehensive administration panel.
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Yes, if you would like to preview the course or the administration panel, please click the following link:
http://www.enggei08.top/default.aspx?page=freepreview
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In order to set up a multi-license account, you would fill in the following purchase order form:
http://www.enggei08.top/default.aspx?page=purchaseorderform
On receipt of your completed order form Infonetica will set up a group account for your organization. Your GCP licenses will be placed into this account and you will be asked to elect one or more group administrators to manage individual license allocation.
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Yes. We understand that having control over the working and learning process is of vital importance. We have developed a very easy to use and comprehensive administrator panel. It allows the group administrator to fully monitor every person’s progress through the course and the exam, as well as generating useful statistics related to exam performance.
To preview the administrator panel, please click the following link:
http://www.enggei08.top/default.aspx?page=login and scroll down.
You will then need to enter the following login details:
User name:
Password:
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The GCP online package includes interactive course chapters with embedded useful documents, links to related websites, searchable glossary, printable course material and key learning points, and a bookmarking facility. Trainees must score 80% on the multiple choice exam to get a certificate.
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Immediately after you have passed the online multiple choice exam, your certificate will download into your user account. The certificate can be saved as an electronic file and also printed out for your training records. If you would like to view a sample certificate please click the following link:
http://www.enggei08.top/Files/Doc/Certificate.pdf
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A single license for our GCP online course costs 125 USD. However, discounts are available for bulk licenses. Please click the following link to see our full price list:
http://www.enggei08.top/default.aspx?page=purchaseoptions
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We accept the following cards: Visa Debit, Visa Credit, MasterCard, American Express and Solo. The payment is processed through Sagepay.
Follow the links on the website to purchase your license:
For a single license, please visit the ‘Purchase Options’ page, choose the options from the drop-boxes, which apply to you, and proceed to pay online by completing the card payment details.
For multiple licenses, please visit the ‘Purchase Options’ page, choose the options from the drop-boxes, which apply to your organization, and click on ‘Send a Purchase Order Form’ to complete the order details.An invoice will be issued, based on the information you provided, which you will use to complete the payment by bank transfer. If your organization prefers payment through a credit card, you will need to fill out a credit card form, in addition to the above-described. Once we have received the completed purchase order and credit card forms, we will complete the transaction on your behalf and send you a receipt for your purchase.
If your organization works on a Purchase Order number system, please ensure that you provide the Purchase order number in the relevant box.
If you or your trust/organization has already purchased multiple GCP licenses and you would like to purchase additional licenses, please enter your order details, ensuring that you enter the name of the organization that holds the existing account in the relevant box. Once we receive your order the licenses will be added to your account and an invoice will be sent to the address provided.
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As a rough guide, it takes an average of one hour to complete each of the nine chapters which make up the course. However, the pace is dictated entirely by the user and those with an existing knowledge of ICH-GCP may complete the course more quickly. The online exam can be taken as soon as preferred and it may take about one hour to complete the 30 multiple-choice questions.
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Users can log in and out of the course at any time. Trainees can work through the course materials at their own pace, whenever they have access to the Internet.
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There is no limit. You can sit the exam as many times as necessary. However, please note that once you have passed the exam - by answering 80% or more questions correctly - you will no longer have access to the exam.
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If you would like to get a receipt for the course, you should send a request to Manish.Kainth@infonetica.net containing your account details as well as a return address.
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Yes, our GCP course has been accredited for 9 Continuing Professional Development credits by the Faculty of Pharmaceutical Medicine, Royal Holloway, University of London.
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Our GCP course is available in many different languages and country-specific versions. Our training course is a perfect solution for international companies who need to train investigators in many different locations. There are several versions of the course, each one is dedicated to a country or a region and, as such, follows the rules and regulations applicable there. Currently, there are versions available for:
- International ICH-GCP – this version of the training covers strictly ICH regulations
and guidelines, which are internationally accepted and serve as basis to each country’s
local GCP regulations. The International version of the training is also available
in Russian, Spanish, Italian, Polish, and Hungarian.
- UK GCP – this version covers both ICH and UK-specific regulations, including statutory
instruments
- US GCP – this version covers both ICH and US regulations, as administered by the
FDA
- German GCP – this version covers ICH and German regulations under the local guidelines
and the AMG (Arzneimittelgesetz)
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If you are a group administrator, your email has been registered in the system as such. If you would like to issue a license to yourself for the course you should use a different email address – this could be either a work or personal email address.
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