This online course has been designed specifically for professionals employed on non-commercial clinical trials and research studies (chief/principal investigators, administrators and managers, quality assurance/control personnel, pharmacists, data managers, research nurses, DPhil students).
The programme covers the key issues of good clinical practice to ensure that clinical trials comply with the ICH Guidelines for Good Clinical Practice, in accordance with the Medicines for Human Use (Clinical Trials) Regulations 2004 and subsequent amendments.
The course uses interactive activities, case studies, scenarios and video interviews to address difference learning styles.
- developed in collaboration with Epigeum and licensed by the University of Oxford
- accredited by the Royal College of Physicians for CPD points
- meets the TransCelerate GCP Training Minimum Criteria
The course is available for those seeking to complete GCP training and can also be used to refresh previous training.
The course is available in five modules.
Protocol and associated documents
- the contents of a GCP-compliant protocol
- how to write and review a study protocol
- the other documents essential for the conduct of a clinical study
Applications, agreements and approval
- the agreements needed for a clinical trial and the division of responsibilities between the sponsor, chief investigator and principal investigator
- the application process for NHS, MHRA and other approvals for a study and common problems that might arise
- the approvals needed to ensure compliance with ICH GCP and how these relate to amendments
Trial master files
- essential documents and the trial master file
- why maintaining a trial master file is essential to trial management
- the archiving process
- how trial master files apply to trial regulation
Conducting the trial
- what needs to be in place before the start of a trial
- the principles behind recruitment and the informed consent process
- drug accountability
- what aspects of the trial need to be reviewed as the trial progresses
- the definitions of the different classifications of adverse events and the associated reporting requirements
- how to assess whether an adverse event is serious, expected and related to the study drug
- the process of expedited reporting
- how to compile an annual safety report
The revalidation assessment is for researchers who currently work in clinical research and wish to revalidate their understanding of GCP, without attendance at face-to-face training or completion of the full online GCP training.
The quizzes are available in five modules:
- Protocol and associated documents
- Applications, agreements and approval
- Trial master files
- Conducting the trial
- Safety reporting
Access is free through online registration.
Elibility: You should be employed either by the University of Oxford or the Oxford University Hospitals NHS Trust, or working on clinical research either sponsored or hosted by one of these organisations. 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.
Frequently asked questions (FAQs)
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. If your GCP training has expired your online GCP account cannot be used to refresh/redo the course quizzes and reissue certificates because the system does not have the capacity to refresh users' course information. A new registration must be completed and submitted and new user details will be sent to you.
Full online GCP course
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.
GCP revalidation assessment (refresher quiz)
There are five quizzes in total, 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.