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Good Clinical Practice

TransCelerate-accredited course on the GCP guidelines including Revision 2


Trainingonline4U Ltd

Summary

Price
£249 inc VAT
Or £83.00/mo. for 3 months...
Study method
Online
Duration
6 hours · Self-paced
Access to content
90 days
Qualification
No formal qualification
CPD
6 CPD hours / points
Certificates
  • Certificate of completion - Free
Additional info
  • Exam(s) / assessment(s) is included in price

2 students purchased this course

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Overview

This is a professionally developed, interactive and engaging online Good Clinical Practice training course incorporating 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.

It meets the required standards for ICH GCP Investigator site personnel training identified by Transcelerate Biopharma inc.

This GCP course has been updated for 2022 with increased interactivity and knowledge checks.

Certificates

Certificate of completion

Digital certificate - Included

CPD

6 CPD hours / points
Accredited by The CPD Certification Service

Course media

Resources

Description

Learning Objectives

Following this course you will:

  • Understand the background and reasons for GCP
  • Understand the Guidelines and Regulations surrounding GCP
  • Know the specific roles and responsibilities of the different individuals and organisation involved in clinical research
  • Understand the Documentation and reporting obligations.
  • Identify a range of essential documents required
  • Know the informed consent process and its key aspects
  • Demonstrate an awareness of safety reporting requirements
  • Understand trial management and trial design.

Who is this course for?

This course is recommended 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.

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).

Requirements

As our GCP course is Transcelerate accredited, this means that this certification is recognised by many different Sponsor companies.

Career path

This course will provide you with all the relevant knowledge and information needed to work in a clinical trial environment, leading to certification upon successful completion of a short exam (80% pass rate required). This course has been designed to incorporate Good Clinical Practice E6 R2 which was finalised in November 2016 and implemented in 2017.

Questions and answers


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Gina asked:

Is your course recognised by Transcelerate? Many Thanks :)

Answer:

Hi Yes our GCP course is recognised by Transcelerate, which means it can be used across multiple Sponsor companies. You can find our company listed on their website for GCP mutual recognition program. Please let us know if you want any more information.

This was helpful. Thank you for your feedback.
Costa asked:

Hi Is this a PowerPoint format lessons please 🤔? Thanks Regards

Answer:

No its an interactive online course. Broken down into small modules. We dont use PowerPoint. Its some small reading, images, videos, quizzes and puzzles all to help the user fully understand the subject.

This was helpful. Thank you for your feedback.
Genotec asked:

Hello, hope you are well. By taking this course will I get all the same information as I would if I was to go on a GCP training day? Many Thanks

Answer:

Hi, Yes, our GCP course is recognised by Transcelerate which means it must contain all the content required so that all Sponsors accept it as recognised GCP training. The advantage of this online course means you can take it at any time to suit yourself and works well on any device. The course is very interactive and engaging rather than listening to long PowerPoint presentations that often lose your interest. Hope this answers your question.

This was helpful. Thank you for your feedback.

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FAQs

Study method describes the format in which the course will be delivered. At Reed Courses, courses are delivered in a number of ways, including online courses, where the course content can be accessed online remotely, and classroom courses, where courses are delivered in person at a classroom venue.

CPD stands for Continuing Professional Development. If you work in certain professions or for certain companies, your employer may require you to complete a number of CPD hours or points, per year. You can find a range of CPD courses on Reed Courses, many of which can be completed online.

A regulated qualification is delivered by a learning institution which is regulated by a government body. In England, the government body which regulates courses is Ofqual. Ofqual regulated qualifications sit on the Regulated Qualifications Framework (RQF), which can help students understand how different qualifications in different fields compare to each other. The framework also helps students to understand what qualifications they need to progress towards a higher learning goal, such as a university degree or equivalent higher education award.

An endorsed course is a skills based course which has been checked over and approved by an independent awarding body. Endorsed courses are not regulated so do not result in a qualification - however, the student can usually purchase a certificate showing the awarding body's logo if they wish. Certain awarding bodies - such as Quality Licence Scheme and TQUK - have developed endorsement schemes as a way to help students select the best skills based courses for them.

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