Following UK government guidelines in response to the COVID-19 pandemic, we will not be holding face-to-face training throughout Wales until advised otherwise.
However, e-learning courses are available and you can complete the training in your own time.
The Introduction to Good Clinical Practice (GCP) and GCP Refresher sessions are available as e-learning courses. They are CPD accredited and a certificate can be downloaded on completion of the course.
For those in associated study roles, such as pharmacy dispensing, we also have the GCP Fundamentals presentation slides.
We are currently working to extend the library of e-learning available from Health and Care Research Wales.
Good Clinical Practice, or GCP, is an international ethical and scientific quality standard for conducting clinical trials. Complying to this standard provides the public reassurance that the rights, safety and wellbeing of the people taking part in the research are taken care of, and that the clinical trial data is credible.
Many research staff are required to complete GCP training and to evidence this with a valid GCP certificate. It is only a legal requirement for staff working on clinical trials of investigational medicinal products (CTIMPs).
There is no timeframe detailed in UK research legislation for repeating GCP training at specific intervals or for expiration of certificates.
The Medicines and Healthcare products Regulatory Agency (MHRA)/Health Research Authority (HRA) stance, on repeating GCP training for those working on clinical trials of investigational medicinal products (CTIMPs), is that it must be appropriate and proportionate.
Often Research & Development (R&D) departments and sponsors have their own local requirements for GCP training updates. Please speak to them about their requirements and inform them of the UK Joint Statement and the all-Wales Standard Operating Procedure (SOP) where relevant.
If you do need to update your GCP certificate there is e-learning available for both the Introduction to Good Clinical Practice (GCP) and GCP Refresher.
All of our GCP training is in collaboration with the National Institute of Health Research (NIHR) Clinical Research Network and is evident by being listed on the TransCelerate website, which is global recognition for the quality of GCP training.
If you are carrying out a limited role within a research study in labs or pharmacy you may not require full GCP training. Our GCP Fundamentals presentation slides provide alternative training.
Please check with your sponsor and Research & Development (R&D) department what level of training they require you to take and refer to the UK Joint Statement and all-Wales Standard Operating Procedure for further guidance.
There is no legal requirement for staff on non-drug studies to complete GCP. However, staff on these studies must be appropriately trained and experienced to carry out their role.
They must be able to conduct the study in a manner which provides the public reassurance that the rights, safety and wellbeing of research participants are protected and that research data is reliable. Please refer to your sponsor and Research & Development (R&D) department for their local training requirements.
No, staff who are not actually conducting any research activity do not require full GCP training. However, it is important that staff have a good understanding of what is going on around them. The all-Wales Standard Operating Procedure states that this can be achieved through internal discussion or training. We have developed a Research Awareness Factsheet that can be used to help with this.
No, the sessions are set up so you can dip in and out prior to completion. When you leave the e-learning page, your session will resume from that point next time.