Good
Clinical Practice

ICH-GCP E6R2

A professionally developed, interactive and engaging online training course.

Delivering unique, exciting and interactive e-learning technology courses.

ABOUT THE COURSE

This is a professionally developed, interactive and engaging online Good Clinical Practice training course which incorporates the ICH E6 R2 update implemented in June 2017.

It is suitable for anyone carrying out or involved in clinical research and will provide individuals with official certification in GCP that is widely accepted by all Sponsors and CROs.

It was created by our subject matter expert who has worked in clinical research for 30 years and has delivered training in GCP all around the world. The course meets the required standards for ICH GCP Investigator site personnel training identified by Transcelerate Biopharma inc. (This can be checked on their website)

 

Finally an online learning platform thats fun, engaging and can be taken on any device, anywhere, anytime.

HOW LONG
WlLL THE COURSE TAKE?

This course takes approx. 2-3 hrs to complete. This time will vary depending on the users previous knowledge and as the course contains lots of links to more information, it will also depend how many the user choose to access.

At the end of the course the user can download and print their own certificate as a record of their course completion.

Good Clinical Practice Online Courses

Good Clinical Practice (E6 R2)

 

£99 (inc VAT)

This is the new updated course of GCP for 2020 to remain current and has improved knowledge checks and interaction to create a more engaging experience for our users.

You will also gain free access to our online course – “Managing Clinical Trials During COVID-19

Taken the older course? If you have taken the older course (if taken before 10th October 2020) and need to access the course to complete or print off your certificate it can be accessed by following this link.

COURSE CONTENTS

 

 

Module 1 – Introduction to ICH GCP/Ethics

Chapter 1 – What is ICH GCP

  • What is Good Clinical Practice (GCP)
  • The Historical background to GCP
  • The Principles of ICH GCP

Chapter 2 – Key Legislation and Regulations

  • Regulatory and Advisory Bodies
  • Key Legislation

Chapter 3 – Ethics and Safeguarding

  • What is an Ethics Committee and why do we need it?
Module 2 - Key people and their responsibilities

Chapter 4 – Investigator

  • Who is an Investigator?
  • Investigator responsibilities
  • Investigator non-compliance
  • Investigator scenario

Chapter 5 – Sponsor

  • Who is a Sponsor?
  • Sponsor responsibilities
  • Quality Management, Risk, QA, QC
  • Delegation
  • Trial Management, data handling and record keeping
  • Investigator and Monitor selection
  • Sponsor scenario

Chapter 6 – Monitor

  • What is Monitoring and why is it necessary?
  • Monitoring approaches
  • Monitoring visits and reporting
  • Monitoring scenario
Module 3 - How is compliance with GCP ensured

Chapter 7 – Patient Safety

  • What is Patient Safety?
  • Who is responsible for Patient Safety?
  • Safety Reporting
     

Chapter 8 – Informed Consent 

  • What is Informed Consent?
  • How is Informed Consent acquired?

Chapter 9 – Investigational Product (IP)

  • What is IP
  • IP responsibilities

Chapter 10 – Protocol and Investigator Brochure 

  • Clinical Trial Protocol
  • Investigator Brochure

Chapter 11 – Essential Documents

  • Essential Documents
  • Electronic records and Trial Master File (TMF)

Chapter 12 – Summary

  • Summary
  • GCP exam
  • Accessing your certificate

I just wanted you to know that I thought the GCP course was good. The right level and I liked the fact you could read more if you wanted to e.g. articles.

Fiona Duthie, PhD
2018-03-26T10:49:01+01:00
I just wanted you to know that I thought the GCP course was good. The right level and I liked the fact you could read more if you wanted to e.g. articles. Fiona Duthie, PhD

"I found the system easy to use and the navigation through various screens was easy too. Varying the way information was accessed and the way the quizzes were done made it more interesting than if it was all the same throughout" 

Veronica
5
2017-08-02T14:39:48+01:00
"I found the system easy to use and the navigation through various screens was easy too. Varying the way information was accessed and the way the quizzes were done made it more interesting than if it was all the same throughout"  Veronica

I certainly enjoyed using the course and I thought it was easy to use overall. I thought the interactive part of the course and a little tests at the end of each section were especially useful.

Ewelina Testoni, PhD
5
2017-12-11T15:31:09+00:00
I certainly enjoyed using the course and I thought it was easy to use overall. I thought the interactive part of the course and a little tests at the end of each section were especially useful. Ewelina Testoni, PhD
5
2

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Phone

0161 633 4594

Address

82 Lane Head Farm, Lane Head Road, Lees, Oldham, OL45RT

If you prefer to speak to someone call us on 0161 633 4594 and we'll be happy to help.

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