Good Clinical Practice (regulated trials) online training
The course covers the key issues necessary to ensure that clinical trials comply with standards of good clinical practice
About the course
The online GCP (regulated trials) training is mainly intended for those involved in CTIMPs research. The principles can also be applied to non-CTIMP research, thus the course is suitable for all types of studies. However, some modules may not be applicable for non-CTIMP research.
Course overview
The full 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 15 randomly generated questions.
- Protocol and associated documents
- Applications, agreements and approvals
- Trial Master Files
- Conducting the trial
- Safety reporting
Registration
This course is only available to University of Oxford (OU) or Oxford University Hospitals NHS Foundation Trust (OUH). Your substantive employment status determines which e-learning to complete:
- If your substantive employer is OU, then use the CoSy e-learning system to register and access the OU Good Clinical Practice training
- If your substantive employer is OUH, then use the My Learning Hub e-learning system to register and access the OUH Good Clinical Practice Training
FAQs
You are eligible to take the course if:
- you are employed by the University of Oxford or Oxford University Hospitals NHS Foundation Trust
- you are a student of the University of Oxford
The NIHR offers an online GCP course for people supporting clinical research delivery at the NHS, UK universities and other publicly funded organisations in England.
If you are affiliated with the University, but do not have an SSO account and cannot access the NIHR training, then you may be eligible to access the training by applying for a 'virtual card access'. Further information on this is available on the University Estates card application webpage.
Your substantive employment status determines the which e-learning to complete:
- If your substantive employer is OU, then use the CoSy e-learning system to register and access the OU Good Clinical Practice training
- If your substantive employer is OUH, then use the My Learning Hub e-learning system to register and access the OUH Good Clinical Practice Training
The courses are online and available 24/7.
The GCP course is comprised of five topics which are split into a content module and a quiz for each topic, making a total of ten elements to complete. These must be completed in the order they appear. You cannot access the next content module in the list until the previous content module and quiz have been completed (with a pass mark of 80%).
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.
The pass mark is 80% in each quiz.
The recommended time is eight hours to work through all the course material and complete the quizzes for all five modules.
Candidates can come out of the course at any time and do not have to fully complete a module, quiz or the entire course at once. The course will save at your current position, ready for you to resume and complete upon your return to the course. Your previous score will be overridden if you have completed a quiz and then re-take it.
You can go back into the quiz and retake it at any time, you will be able to retake it as many times as you require until you have passed. The quiz questions are taken from a bank and there will be a different set of 15 for every attempt in each module. Your previous score will be overridden if you have completed a quiz and then re-take it.
No, there is no refresher course available at present. We have recently moved to new hosting platforms, so all eligible candidates must complete the full course the first time they access the course through the new e-learning systems.
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 NHS 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 regulations and requirements. 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 training is renewed every three years.
It is the responsibility of all delegates completing the training to have an up-to-date copy of their certificate available for audit purposes. Please ensure you keep a copy of your certificate. Failure to do so may result in having to complete the full training again.
If your substantive employer is the University of Oxford, or you are a student of the University, then use the CoSy e-learning system to register and access the OU Good Clinical Practice training
To book a course login to CoSy, with your university single sign-on (SSO), and then book the 'Good Clinical Practice' course by adding it to your shopping basket and checking out. Once you have booked the course, it will show in the 'My eLearning' tile on your dashboard.
A 'Play' button will appear next to the course title. Click 'Play' to start the course. When you have finished the course, make sure you exit it as per the instructions within the course.
eLearning courses need to be booked in the system. If the course does not appear in your 'My eLearning' tile, please book the 'Good Clinical Practice' course.
Please check the browser you are using - we recommend a modern, up-to-date browser (e.g Chrome or Edge).
You need to take the quiz after each content module to proceed. The 'Play' button will not show for any modules where you have not taken the quiz for the previous module.
For the Good Clinical Practice module, the courses must be completed in order (content, followed by quiz). Access to the next course in the list will not be granted until the previous topic's quiz has been completed and passed (with a pass mark of 80% in each quiz). Your previous score will be overridden if you have completed a quiz and then re-take it.
It is recognised that the success status within CoSy for each of the content modules remains as 'Awaiting Assessment'.
The CoSy support team will complete routine checks for this status and will update CoSy to change the 'Awaiting Assessment' status into a 'Passed' status for all individuals who have completed the course.
It is recognised that the status within CoSy, for an overall module, may say 'Not Started' even though you have completed it.
The CoSy support team will complete routine checks for this status and update CoSy to change the status to 'Completed' for all individuals who have completed the course.
If you do not receive a confirmation email, ensure that you have clicked on the 'Exit' button when completing the eLearning course. If you still have not received an email within 1 hour, contact cosy-support@it.ox.ac.uk.
You will receive your certificate, via email, after completing the fifth and final quiz (safety reporting).
You can also access your certificate at any time via the 'My Awards' section of your CoSy account.
In the 'My eLearning' tile there is a column that shows your score for each quiz. Your previous score will be overridden if you have completed a quiz and then re-take it. Any previous scores will be listed in the column.
If your substantive employer is OUH, then use the My Learning Hub e-learning system to register and access the OUH Good Clinical Practice Training
Please contact the OUH Research & Development Team if you are having difficulty accessing the system. Email them on OUHTMA@ouh.nhs.uk
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.
