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Joint Research Management Office

Breadcrumb

  1. JRMO
  2. Performing research
  3. Conducting research in the NHS
  4. Setting up a study

Setting up a study

Is it research?

The Health Research Authority (HRA) has published a decision-making toolkit to determine whether a piece of work, a project or an investigation is classified as research. 

Only research requires a submission to the Research Ethics Committee, the Health Research Authority (HRA) or approval from the JRMO. Clinical Audits, Service Improvement Projects and Service Evaluations are not research. However, if conducted within Barts Health, they will need to be registered with the Clinical Effectiveness Unit or, if you are outside of Barts Health, contact them at bartshealth.clinicaleffectiveness@nhs.net 

If you are unsure whether your work should be defined as research, audit or service evaluation, please contact research.governance@qmul.ac.uk 

Roles within trials, what counts as a site, along with other matters about setting up, running and closing studies are explained on the HRA website and the IRAS MyResearch website.

Al research needs costing – for further information see the C&C section of this website and Worktribe.

Applications and Approvals

You may also require a Capacity and Capability review at the site level (the JRMO or NIHR North Thames CRN, as applicable, will assess the capacity and capability for Barts Health or Queen Mary if named as a site); and/or site activation and sponsor green light (for studies regulated by the MHRA, the sponsor will confirm sponsor green light and permission to activate sites).

  • If the research is being conducted as part of either an educational qualification or employment with Queen Mary you should seek approval from the QMERC before commencing your research.
  • The Medicines and Healthcare Products Regulatory Agency (MHRA) part of each application is completed within IRAS but submitted to the MHRA via the Central European Submission platform [CESP]. Access to CESP will be given during the sponsorship process by the GCP team. The MHRA has produced a clinical trial algorithm to help you decide if you need to complete a CTA and how to apply. The MHRA will inform the researchers of a decision regarding the CTA form within 60 days. There is a fee associated with this application.
  • To obtain an EudraCT number, where relevant, go to the EudraCT website. Request a security code, which will be sent to you via e-mail. This email MUST be kept securely as the MHRA does not accept applications without it. Upon receipt of the code, you can apply for the EudraCT number on the same website.
  • If you are planning a project involving a medical device, you may need to obtain a 'Letter of No Objection' from the MHRA. A Letter of No Objection can be obtained by completing the MHRA Devices form on IRAS and submitting it to the MHRA with supporting documentation.

Should you require assistance with any of this please email research.governance@qmul.ac.uk 

The legislative framework

Good Clinical Practice is mandatory for all CTIMPs and recognized as the best practice for all other clinical research. For more information on this, including the internationally accepted principles of GCP see NIHR online guidance.

All research conducted with or involving NHS patients, staff, data, or facilities must comply with the UK Policy Framework for Health and Social Care Research This outlines the principles of good governance applying to all research.

Other regulations may also apply:

Please seek advice from the research governance team if you need advice about what is relevant to your study: research.governance@qmul.ac.uk 

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