University of Southampton IV Year Medical Students

SUHT R&D Approval Process

Version 1.2 18-09-07

SUHT R&D approval process version 1.2 18-09-07

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Core Documents - What they are and where to find them

1. Application for SUHT R&D approval checklist: To be completed for all applications and must accompany core documents. Available from HERE.

1. NRES application form, parts A&B: The standard National Research Ethics Service (NRES) application form used by all NHS Research Ethics Committees is web-based & can be found at the NRESwebsite.

1. Study Specific Information Form (SSIF) for SUHT: The SSIF is the national NRES form used for applying to local REC for site-specific assessment (SSA) where required, & for applying to NHS R&D offices in England. To create an SSIF you will need to follow the instructions on the NRES website. For local guidance on how to complete the form see SCRI Information Sheet 7a: Completion of Site Specific Information Form for SUHT/UoS Joint R&D Office.

1. SUHT R&D Non-commercial costing form: A local form designed to provide information required on the cost of the study to the organisation. It is vital that this form is completed accurately. For assistance please contact Michelle Cawte x5146. Available from HERE.

1. Protocol: A document that describes the objective(s), design, methodology, statistical considerations & organisation of a study. The protocol also usually gives the background & rationale for the study. Guidance on writing protocol is available on the Information Sheets page. Assistance in also available from the Research and Development Support Unit.

1. Participant Information Sheet(s): An information sheet given to those who have been invited to participate in a research study. Guidance on how to write a PIS is available HERE.

1. Consent form(s): A form signed & dated by a study participant which voluntarily confirms their willingness to participate in a study after having been informed of all aspects of the study relevant to the their decision to take part. For more on consent forms please look at this Information Sheet.

1. Invitation letter(s) (if applicable): The letter sent to potential research participants inviting them to participate in the research.

1. Evidence of sponsorship where SUHT or UoS is not sponsor: This may be in the form of a letter or contract issued by the sponsor.

1. UoS insurance form: A local form to be used where research involves the University of Southampton & designed to provide the UoS with the information required to secure necessary insurance. Available from HERE.

1. MHRA Clinical Trials Authorisation (if applicable): The regulatory approval for a clinical trial of an investigational medicinal product issued by the Medicines & Healthcare products Regulatory Agency. It replaces the previous CTX, DDX. To determine whether your study is a clinical trial go to this Information Sheet. To apply for a CTA go to the MHRA website.

1. MHRA Medical Devices Approval (if applicable): The regulatory approval for a clinical investigation of a medical device issued by the Medicines & Healthcare Regulatory Agency (Medical Devices). Further guidance is available from the NRES website – Medical Device Guidance booklet.

13.Contract /Agreement (if required): This will be the contract or agreement issued by the sponsor or the funder or both.

14.Evidence of Funding (if funded): Issued by the funder for funded studies.

15.SUHT Data protection application: Data Protection approval is required from SUHT as part of the R&D Approval Process. Please click here for the Data Protection registration pack.

16.ARSAC (Administration of Radioactive Substances Advisory Committee) certificate (if applicable): The person administering radioactive materials must hold an ARSAC certificate which is site-holder and procedure-specific. For further guidance see the Radiation Guidance booklet and the Radiation Guidance flowchart.

17.Radiation protection approval (IRMER): The Ionising Radiation (Medical Exposure) Regulations 2000 (IRMER) govern the exposure to ionising radiation of patients or other persons voluntarily participating in medical or biomedical, diagnostic or therapeutic research programmes. Detailed guidance is available on the Radiation Guidance booklet and the Radiation Guidance flowchart.

18. NRES favourable opinion letter: Issued by the Main Research Ethics Committee confirming a favourable opinion to conduct the study. Please note, for multi-centre research studies that are NOT Site Specific Assessment exempt (see NRES website), the ethics approval letter must list Southampton as an approved site.

SUHT R&D approval process version 1.2 18-09-07

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