Training | What training do I need to attend?
What training do I need to attend?
The JRMO provides training for a variety of research projects that it oversees.
It is the responsibility of those working in research to book onto the appropriate course and to ensure training is completed prior to working on a project. If a project is in design/ set-up please contact the JRMO at researchtraining@bartshealth.nhs.uk.
The following training is available:
- Research GovernanceFramework (RGF)
- Good Clinical Practice (GCP)
- GCP Refresher
- Other training options (Making better R&D applications; Tissue storage; Taking informed consent)
In general, if you will be working with a study of an Investigational Medicinal Product (IMP), you will need to atttend the GCP course. If not, the RGF course is usually sifficient. If you are unsure whether your study is a clinical trial of IMP (CTIMP) please refer to the MHRA CTIMP algorithm.
Research that requires R&D and REC approval: Research Governance Framework (RGF) Training (half day)
All research staff must ensure that research projects are conducted according to the Research Governance Framework.
This course explains the requirements of the RGF, which is applicable to everyone involved in research. The course is run for half a day (usually between 9am and 1.30pm)
This course is mandatory for research staff wishing to undertake any kind of research within the Trust or University.
Research that requires R&D, REC and MHRA approval (CTIMPs): Good Clinical Practice (GCP) training (one day)
The Medicines for Human Use (Clinical Trials) Regulations 2004 require that research active staff must be aware of all relevant legislation so they can adhere to its constraints. The GCP course is for anyone working on a trial of an Investigational Medicinal Product (IMP), such as a novel drug or a licenced drug in an unlicenced form.
The Good Clinical Practice (GCP) course has been set up to inform research active staff of their roles and responsibilities within the scope of the Directive and the processes required by the regulations. The GCP course covers all ofthe material on the RGF course, but with an emphasis on appliactionof the legislation to CTIMP studies and with more information.
The course is mandatory for research staff wishing to undertake Clinical Trials of Medicinal Products (CTIMPs) within the Trust or University.
GCP Refresher
This course is designed for those who have completed the full day GCP course and needs to be attended every 2 years (post initial training). It lasts about two hours. It exists to update researchers on new legislation and amendments since the introductory training. Between courses it is useful if researchers visit the JRMO website for updates and read the R&D News Bulletin.
Please note, if you are to be involved with a Clinical Investigation (device trial that requires MHRA approval i.e. non CE marked, or with commercial intent), then please book onto the RGF course.
Other Training Options
The JRMO also runs other workshops, such as how to complete submissions (see making better R&D related submissions for further information).
In addition the JRMO recommends the following external online training:
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Tissue storage
Tissue stored (not as part of an active research project) in a licensed tissue collection centre must be registered with Graham Tate who is the Designated Individual in accordance with the Human Tissue Act Bank License. For those involved in tissue storage please see more information at: Human Tissue Resource Centre
A useful free, online training exercise about Tissue Storage, that is certificated on completion, is provided by the MRC: Human Tissue Act training
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Taking informed consent
