If you are a researcher wishing to carry out a research study at University Hospitals Bristol we hope the information on this part of our website will guide you through the process.

The R&I Department have created a number of process maps to help you plan your study and follow the correct procedures. Please click on the links below to access the maps

Preparing, writing and submitting NIHR grant applications through UH Bristol

Register Project with Research & Innovation

Submit for Sponsorship to Sponsorship Issued

Complete IRAS to NHS Permission Granted

We want to help you get your research started as quickly and easily as possible, so either follow the relevant links for further guidance, or if you cannot find the information you need, contact Research and Innovation on 0117 342 0233.

Guidance is available on:

• how to check your work is research and not audit or service evaluation
• how to get help from the Research Design Service (RDS) in protocol development, study design, data management and analysis etc.
• setting up a study
• how to get Trust and ethics approval

Information is also available on:

• training courses
• national and local funding opportunities
• The Trust's research governance polices

Information on funding opportunities from the National Institute for Health Research (NIHR) can be found here 

For performance on initiating clinical research, UH Bristol must now measure and publish data on the days elapsing between the time we receive a valid research application for a clinical trial and the time when the first patient is recruited to the trial, for all the clinical trials we host. This applies to all clinical trials irrespective of the funder. Wherever the duration exceeds 70 days, we will be expected to explain the reason  for the delay to the NIHR in writing. Fore more information on what the NIHR targets consist of and how we can reach them, read our guidance document.

If you have any queries on the process, phone Research and Innovation on 0117 342 0233 and we will be happy to help.

Contract commercial research - information for sponsors and CROs

UH Bristol supports commercial research where it is of a high standard and of benefit to our patients and the Trust as a whole.

Companies wishing to undertake commercial clinical trials should contact Research and Innovation as early as possible to ensure that appropriate reviews and approvals required prior to starting the study are initiated in good time. This includes R&D approval, review of costings and contract, and signature of the contract.

Trust approval

For information about the approval process, including support department proformas, please view our page.  Our key contact to help you with the Trust approval processes is Jake Harley.  Jake's direct dial number is 0117 342 0229.

Lab accreditation

Evidence of Clinical Pathology Accreditation (CPA) for our laboratories can be found on the CPA website. To find the relevant laboratories for this Trust, select Medical Laboratories in the left hand menu, then choose Avon, Gloucester and Wiltshire and Bristol in the Area and City boxes, then search.  It should not be necessary to request a hard copy certificate in addition to this evidence

Whilst R&D approval is the responsibility of the Principal Investigator at UH Bristol, companies may wish to discuss with PIs whether support in preparing the paperwork can be provided. Other requirements are as follows:

Contracting

Information on the Trust's preferred contract for commercial clinical trials of investigational medicinal products (IMPs)/devices, together with additional hints and tips is available.

Indemnity

If the mCTA is not in use, the standard ABPI or ABHI form of indemnity is required in addition to the contract. Two copies of the ABPI form on Trust headed paper should be printed, completed by hand, signed and returned to this office with the contract.

Protocol

The Trust is responsible for the recovery of funds for care/procedures over and above normal clinical care. A protocol (one hard copy, one electronic copy preferred) is required in order to assess the costs of the study; this will be done by this office in conjunction with the Investigator, support departments and the finance department, prior to agreeing the fees in the contract.

Charges and costing

Information on set up fees and other costs for commercial studies is available here.

Timelines

In order to help you meet your timelines, it is helpful if you can provide us with the following information:

• Expected date of REC approval
• Planned dates of Initiation visit, first patient first visit & last patient last visit

e-data collection

To find out more about the solutions the Trust can offer to collecting e-data, visit this page.

Contact details

Information on staff contact details is available here.

Further reading

• Guidance to facilitate the conduct of commercially funded research in the NHS

This guidance document, produced jointly by the NHS R&D Forum, the Institute of Clinical Research and the Association of the British Pharmaceutical Industry was launched in February 2007.