GCP online course and refresher course

The course covers the key issues necessary to ensure that clinical trials comply with the standards of good clinical practice, in accordance with the Medicines for Human Use (Clinical Trials) Regulations 2004 and subsequent amendments.

It is in line with national developments in research systems and has both Royal College of Physicians accreditation and TransCelerate endorsement, a standard generally recognised by industry sponsors.

Course options

Full course

Refresher course

The full GCP course is highly interactive, including a wide variety of exercises, illustrative video dramas and interviews. It is made up of five modules.

Each module is assessed by 20 randomly generated questions.

A revalidation assessment is available for researchers who currently work in clinical research and wish to revalidate their understanding of GCP.

Assessment is through quizzes covering the five course modules.

 

Course overview and registration

Modules

  • Protocol and associated documents
  • Applications, agreements and approvals
  • Trial Master Files
  • Conducting the trial
  • Safety reporting
     

Eligibility

The full course and refresher course are available free of charge to anyone involved in clinical trials sponsored or hosted by either the University of Oxford or Oxford University Hospitals NHS Foundation Trust (OUH). This access applies wherever in the world an individual is located.

Registration

Complete the online registration form and once eligibility has been established, a username and password will be issued for access to the course. Please note that it can take up to 48 hours for access details to be sent to you.

FAQs

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You are eligible to register for this course if:

  • you are employed by the University of Oxford or the Oxford University Hospitals NHS Foundation Trust, or 
  • you are working on a research project sponsored by either organisation, or 
  • you are a student of the University of Oxford.

Eligibility will be checked on registration.

There is a link on the course homepage to reset usernames and/or passwords.

This depends on your employer's policy, the policy of the sponsor of the research study you are working on, and/or the policy of the trust where the research takes place, and your previous experience.

The frequency of GCP training is not specified in the regulations. However, it is recommended that training is given at intervals appropriate to ensure staff maintain awareness of the current UK and EU regulations. If you have just participated in training and a relevant regulatory change is made, you will need to be informed of these changes and understand their implications for your practice. The University recommends that certificates are renewed every three years.

You will need to re-register for the online course via the registration page.

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There are five course modules in total, covering all aspects of GCP training: protocol and associated documents; applications, agreements and approvals; trial master files; conducting the trial; and safety reporting.

Yes, all five modules make up the required GCP training.

There are five individual module certificates available to view/download once the module quizzes have been completed. Please note there is no overall course certificate. You will need to present the five individual module certificates as evidence that you have completed the course.

There is no upper limit to the number of attempts allowed to pass the module quizzes. The quiz questions are taken from a bank and there will be a different set of 15 for every attempt in each module.

Each of the five module quizzes requires an 80% or higher mark to pass and receive a module certificate.

Via the course overview administration page: click into each of the five module hyperlinks to view/print the certificates.

There are no time restrictions. You are free to log in and out as you see fit. The course gives estimates of how long it will take to review the material in each module and complete the quizzes.

The recommended time is eight hours to work through all the course material and complete the quizzes for all five modules.

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There are five quizzes covering all aspects of GCP training: protocol and associated documents; applications, agreements and approvals; trial master file; conducting the trial; and safety reporting.

 

Yes, all five quizzes make up the required GCP revalidation course.

There are five individual certificates available to view/download once the quizzes have been completed. Please note that there is no overall course certificate: you will need to present the five individual module certificates as proof that you have completed the revalidation.

You are allowed only one attempt at each quiz.

Each of the five quizzes requires an 80% or higher mark to pass and receive a certificate.

Via the course overview administration page: click into each of the five module hyperlinks to view/print the module certificate.

You will need to complete each quiz within 30 minutes.

You will be given the option to self-enrol in the full GCP training course where you can work through the course material and take the module quiz.

Representatives of NHS trusts and universities across the UK collaborated to create this online course, which was driven by Epigeum, a spin-out company from Imperial, now owned by Oxford University Press.

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