WAHT processes

If you wish the Trust to act as sponsor for your research study you should:

• contact the Research & Development Dept. as early as possible by email or phone, to request a study number.
• where other departments will be asked to provide resources or services, contact them and arrange an appointment to discuss what is required.
• pro-formas should be completed for feasibility and used as a basis for discussion when contacting support departments e.g. pharmacy, radiology (or using ionising radiation), laboratory medicine or MEMO.
• complete a request for sponsorship form as early as possible.  A copy of the study protocol should be included with the request. At this stage it is acceptable to name WAHT in the protocol as the sponsor of the study, despite formal approval not having been received. In the event of the Trust not agreeing to sponsor the study the protocol will, of course, need to be amended.
• e-mail the sponsorship request form, protocol and, where applicable, pro-formas and scientific reviews to the Research & Development Dept..

Follow this process map to help guide you through the steps

Before agreeing to act as sponsor the Trust will need to assure itself of the scientific quality of the study and that the protocol contains all required information.

Suggested standard text is available to be included for IMP (Investigational Medicinal Product) studies and for non IMP studies.

A flowchart settting out which individuals and departments should be considered when writing your protocol is available. Also available is more detailed information on writing a protocol including sections on standard text.

Requests for electronic authorisation by the sponsor on the IRAS system should be sent to: mailto:wnt-tr.researchmailbox@nhs.net  

 Assessing scientific quality

• If your study has been or will be reviewed for scientific quality by an external funder and this can be evidenced it may not need further review.
• Where external review has been conducted you must send us a copy of the reviewers' comments and any responses.
• If the study will not be reviewed by an external funder, or further review is considered desirable, the Research & Development Dept. will arrange for this to be undertaken prior to agreeing to act as sponsor.
• Where the Trust agrees to act as sponsor we will provide a provisional sponsorship letter outlining responsibilities; The Trust may then be named as the sponsor on subsequent applications to the MHRA (Medicines and Healthcare products Regulatory Agency), NRES (National Research Ethics Service).
• WAHT's agreement to act as sponsor is not approval for the study and is conditional on full Trust approval being gained through the normal study approval processes.