PharmaSchool Online Course: EU Clinical Trial Regulation

Price and Information about the Course
EU Clinical Trial Regulation
Price: $79
Price Includes: Course Manual, Self Assessments, Examination (and retake if required), Certificate
Satisfaction Rating by Users: 4.45 out of 5
 
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Details of the Course: EU Clinical Trial Regulation

Description

The new Regulation covering clinical trials in the EU will bring about some major changes in the approval and conduct of clinical trials in EU Member States. This module provides a detailed introduction to the requirements of this legislation and also highlights the key differences from previous legislation.

Who is this module for?

Everyone involved in conducting clinical research in the European Union.

At the end of this module you should know

The background to the introduction of this legislation
The main requirements of this legislation
The main differences from previous legislation

Course Content:

Background

The European Union And European Legislation
Development Of The New EU Regulation (536/2014)

Part 1: General Concepts And Considerations

Part 2: Articles Of The EU Regulation

Chapter One - General Provisions
Chapter Two - Authorisation Procedures
Chapter Three - Authorisation Procedure For A Substantial Modification Of A Clinical Trial
Chapter Four - Application Dossier
Chapter Five - Protection Of Subjects And Informed Consent
Chapter Six - Start, End, Temporary Halt, And Early Termination Of A Clinical Trial
Chapter Seven - Safety Reporting In The Context Of A Clinical Trial
Chapter Eight - Conduct Of A Clinical Trial, Supervision By The Sponsor, Training And Experience, Auxiliary Medicinal Products
Chapter Nine - Manufacturing And Import Of Investigational Medicinal Products And Auxiliary Medicinal Products
Chapter Ten - Labelling
Chapter Eleven - Sponsor And Investigator
Chapter Twelve - Damage Compensation
Chapter Thirteen - Supervision By Member States, Union Inspections And Controls
Chapter Fourteen - IT Infrastructure
Chapter Fifteen - Cooperation Between Member States
Chapter Sixteen - Fees
Chapter Seventeen - Implementing Acts And Delegated Acts
Chapter Eighteen - Miscellaneous Provisions
Chapter Nineteen - Final Provisions

Annexes I-VII

What Prior Knowledge is Needed?

This module covers the EU Clinical Trials Regulation which we expect to be implemented in 2017. It does not cover any of the other regulations and guidelines which govern clinical research in medicinal products. [See the current version of the PharmaSchool module Essential Regulations and Guidelines] Nor does it cover the drug development process, the clinical trial process or the pharmaceutical industry. It is helpful, though not essential, to have this background knowledge in advance of taking this module. There are other PharmaSchool Modules available that cover this information.

Overview of PharmaSchool Online Modules

Over 10,000 users have completed PharmaSchool Online Modules & Packages. They are globally recognised as providing cost effective, high quality and relevant training and certification to new and existing clinical researchers. The modules have been used in over 50 countries by the full range of clinical research and clinical trial roles.

Individual users can purchase the modules by adding to basket underneath the description below.

If you are interested in purchasing for multiple users click here to learn about our Multi User Schemes

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EU Clinical Trial Regulation Online Module $79
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About PharmaSchool Online Learning

Each module consists of two components: Course Manual and Learning Management Centre (LMC). If you already have purchased online modules you can login to your account by clicking here.

Course Manual & LMC

The Course Manual provides the information for the module. This Manual is designed to be used as the core component of each Module. The Manual is organised into chapters that will take around 2 hours each to complete. Once you have read a chapter you will then be directed to the online LMC. The LMC contains links to websites that are referenced in the Course Manual, Self Tests to test your understanding of the material, model answers, a Q&A section and the examination. The manual is available in pdf format. This means it can be downloaded and printed and therefore allows you to study away from your computer as well as enable you to make notes, highlight sections and quickly access information when needed.

Examination

Once you have completed the module you can take the examination. The examination is in multiple choice format. You have 90 seconds to answer each question. You can access each question just once. You may pause the examination after any question.

Certificate

Once you have completed the exam you will be able to download your certificate and print if desired. The certificate will include PharmaSchool's unique Certificate Verification Code (CVC) which will enable inspectors, auditors and prospective employers to verify the authenticity of your course.

Feedback from Users

"Great Module. I enjoyed while studying the Course Material. Thank you very much to Pharmaschool." (ES1)

"Very informative, well balanced and excellent resources." (ES3)

"Overall a very good course with the right amount of content and a modular design that meant it was easy to pick up and put down over several days study." (ES2)

"It was fantastic study and I have gained alot and very confident and happy to be clinical research nurse." (ES2)

"Very nice course, hardcopy manual really easy to follow, excellent links. I am really impress that the examinations are fair in the level of difficulty." (ES5)

"I found the course and accompanying tests and exam nicely challenging and a huge help in understanding what is actually in the documents referenced - challenges what I thought I knew." (ES6)

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Can I purchase a corporate license for a group of people: Multiple Users from 25/$37/30

You can contact PharmaSchool to ask for a proposal to meet your organisation’s needs. We currently work with organisations who have purchased from 10 modules up to over 2000 modules from us.

If you are an organisation wishing to buy online learning modules for a groups of your staff or investigators then the Corporate Purchase Schemes start from just £25/$37/€30 per module per user. Unlike many schemes that offer a discount based on how many modules are purchased at a single point in time, the PharmaSchool scheme offers discounts for purchases over a period of time. This means that our customers can obtain a discount for the initial purchase and then any further modules added into the scheme afterwards will attract the same discount or more. The discount thresholds are cumulative so once the next discount level is reached (based on total number of modules in the scheme) all subsequent purchases will attract the new discount level.

Our unique Customer Participant Management Centre allows the lead user to assign modules to users, review progress, monitor the average examination scores across all users as well as access certificates.

We have a wide range of Corporate Users including Pharma, Biotech, CROs, Contract Manufacturing, Health Service providers and Investigational Sites.

For more information please contact us at sales@pharmaschool.co

Licenses

Customers can purchase a fixed number of unnamed participant access accounts

Allocating people to a modules

A Customer Participant Management Centre (CPMC) is set up for the customer. The CPMC provides an easy to use self managed system to allocate new participants to the Flexible Online Learning Modules and also allows the lead user to review the examination results achieved by each participant.

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How do I purchase modules?

The process is straightforward.

Shopping Basket

Firstly you fill your basket with which modules you would like to purchase. You can do this by either viewing the basket from the link on the right hand side or by going into each module description and again adding the module to your basket.

Once you have filled your basket you then need to checkout. You can again do this from the link on the right hand side.

Input Details

Complete the details of the person who will be taking the modules and you will then be shown your order screen. Make a note of the invoice number and access number as these will allow you to return to the order at a later date and to check the status of the order.

Payment

At this point you can choose to pay online using the Secure PayPal System or you can print the invoice and mail that to PharmaSchool with a cheque.

If you pay online as soon as you have completed the payment you will have access to the online components and if you have elected for electronic course manuals these will be available immediately.

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Do I get a certificate?

Yes. The format of your certificate will depend on how you elected to receive the course manual.

If you elected for an electronic course manual then you will be able to download your certificate on completion of your examination.

If you elected to receive a hard copy course manual then you will receive a certificate with your manual. When you have successfully completed the examination you will be given a Certificate Validation Code (CVC). This CVC will be added to your certificate. The CVC allows auditors, inspectors or managers to verify the authenticity of the certificate using the Online CVC Checker.

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Can I pay in other ways

There are three ways you can pay.

  1. Payment by credit card online or by PayPal online
  2. Print off and post the invoice along with a cheque
  3. Your organisation can be invoiced directly – if you enter your purchasers details for the invoice then you can print the invoice and pass to them for payment. Alternatively you can e-mail us at sales@pharmaschool.co to request an invoice.

Payment by credit card will result in the most rapid access to the modules as we are unable to grant access or dispatch manuals until payment has been received.

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Is there an examination?

Yes. At the end of each module an examination is required in order to validate your certificate. The examination consists of multiple choice questions and is accessed via the link in the bottom right hand corner of the Learning Management Centre page for the module. The way the examination works is as follows:

  • Once you elect to begin the exam you are presented with the first question. You have 60 seconds to answer the question.
  • Once you have submitted your answer to a question you will not be able to access that question again – this is to preserve the integrity of the exam.
  • You can quit the exam at any time and return to the point at which you left it at a later time. This is to allow for interruptions such as telephone calls.
  • When you complete the exam you will be presented with your Certificate Verification Code, which you should enter onto your certificate. You will also be given your score for the exam.

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How long do I have to take the course

You have access to the online components of the module for 1 year from the purchase date. If you find yourself unable to complete the module in that time please contact us and we will discuss alternative arrangements with you.

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Will the Courses help me get a job?


Our Online Courses are used throughout the World by individuals and organisations including Pharma, Biotech, CROs, Healthcare Providers, Academic Institutions and Investigational Sites. Feedback is always positive from individual users and many have gone on to secure a position within the industry of their choice. Recent feedback includes:

"Dear Pharmaschool, I finished module 1, pass the exam, got the certificate and finally got the job I wanted! THANK YOU! I am continuing my modules with great pleasure, and I have nothing but words of praise for you"

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Why is it called Flexible Online Learning

Many of the eLearning options available have limitations which can lead to frustrations. These limitations include:

  • difficulty reading and learning from the screen
  • inability to make notes and highlight points of interest on screen
  • ability to take tests/exam numerous times until achieving a pass mark
  • lack of tangible documentation at end of course

By including the option of a hard copy manual, PharmaSchool Flexible Online Learning addresses these issues by basing each module around 2 key elements, the Course Manual and the Learning Management Centre. The Course Manual provides written information and instructions for the module. This is supplemented by the Learning Management Centre which provides online self assessment exercises, essential links, online dictionary and a question and answer forum. In order to receive a certificate for the module an online examination is taken at the end of the module.

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Do I get a discount if I buy more than one module?

Yes. A multiple purchase discount will be applied to your shopping basket if you purchase more than one module at a time. The multiple purchase discounts range from 10% if you buy two modules, up to 25% if you buy five modules. The multiple purchase scheme only applies to individual users purchasing modules for their personal use.

For more information about our Corporate Scheme please see the relevant FAQ.

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How do I use a discount code?

To use your discount code please follow the online purchasing process and you will be asked to enter your code before making payment.

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Multiple Users from 25/$37/30

If you are an organisation wishing to buy online learning modules for a groups of your staff or investigators then the Corporate Purchase Schemes start from just £25/$37/€30 per module per user.

Our unique Customer Participant Management Centre allows the lead user to assign modules to users, review progress and monitor the average examination scores across all users.

We have a wide range of Corporate Users including Pharma, Biotech, CROs, Contract Manufacturing, Health Service providers and Investigational Sites.

For more information please contact us at sales@pharmaschool.co

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How long will the course take?

The time taken to complete each module will depend partly on how much reading around the subject you choose to do. It is estimated that each module takes a total of between 10 and 20 hours to complete, but this time can be spread over several days, weeks or months as you choose.

You have access to the module for 1 year from the purchase date. If you find yourself unable to complete the online components of the module in that time please contact us and we will discuss alternative arrangements with you.

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What is the difference between the ICH GCP Certificate and the GCP and Essential Guidelines Module?
The two modules contain the same information and material about ICH GCP, however, GCP and Essential Guidelines includes additional material covering the US and EU Guidelines. You do not need to take both. We recommend that if you are working with EU or US Trials you follow the GCP and Essential Guidelines Module.

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