WAHT 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.
For information about the approval process, including support department proformas, please view our page.
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 WAHT, companies may wish to discuss with PIs whether support in preparing the paperwork can be provided. Other requirements are as follows:
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.
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.
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.
Information on set up fees and other costs for commercial studies is available here.
In order to help you meet your timelines, it is helpful if you can provide us with the following information:
To find out more about the solutions the Trust can offer to collecting e-data, visit this page.
Information on staff contact details is available here.
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.