Research Policies & Forms

From writing your initial proposal to statistical requests and patient & public involvement, here you will find all the documents, forms and standard operating procedures you will need to develop and set up your research idea at North Bristol NHS Trust.

Our Standard Operating Procedures (SOPs) should be used by Chief and Principal Investigators, Research Nurses and all other research personnel. They provide detailed guidance on all aspects of research study management from design through to completion.

If you are an NBT staff member, the current research SOPs should first be accessed via our Managed Learning Environment (MLE) in accordance with the Research Staff Training SOP. This will provide you with an electronic training record to evidence that you have read each SOP.

It is the responsibility of all staff who carry out research to ensure you are using the latest SOP.

If you would like a copy of any of the documents below, please contact:

Policies & Guidance

R&I - (PO1) Commercial Research Policy

R&I - (PO2) Sponsorship & Central Trial Management Fees Policy

R&I - (PO4) NIHR Research Funding Recovery Policy

R&I - (PO5) - PPI in Research Payment Policy

R&I – (P03) Excess Treatment Costs In Research at NBT has been suspended. All new research projects with excess treatment costs require approval from the General Manager/Clinical Director.

Study Set-Up

Guidance on Allocation of Research SPA time for Consultants

R&I NBT HRA Checklist

R&I Making amendments to NBT Sponsored studies that have HRA approval

R&I Setting up new studies where NBT are sponsor

Standard Operating Procedures

Ref: RI/QMS/SOP/001 : Preparation of Research Standard Operation Procedure

Ref: RI/QMS/SOP/002 : Obtaining R&I Confirmation for Research to Start

Ref: RI/QMS/SOP/003 : Research Study Amendments

Ref: RI/QMS/SOP/004 : Maintenance of Research Equipment SOP

Ref: RI/QMS/SOP/005 : Research Staff Training

Ref: RI/QMS/SOP/006 : Honorary Research Contract Letters of Access SOP
Ref: RI/QMS/SOP/006a External Researcher Information Form

Ref: RI/QMS/SOP/007 : Applying for NBT Sponsorship SOP
Ref: RI/QMS/SOP/007a Sponsorship Request Form
Ref: RI/QMS/SOP/007b NBT Terms of Sponsorship
Ref: RI/QMS/SOP/007c Delegation of Responsibilities
Ref: RI/QMS/SOP/007e Declaration Form

Ref: RI/QMS/SOP/008 : Writing a Protocol for ctIMPs
Ref: RI/QMS/SOP/009 R&I Periodic Reporting to Regulatory Authorities
Ref: RI/QMS/SOP/010 : Archiving
Ref: RI/QMS/SOP/011: R&I Closing Suspending and Terminating Research

Ref: RI/QMS/SOP/012 : R&I Managing Breaches of GCP or the Protocol
Ref: RI/QMS/SOP/012a : ICH GCP NonCompliance Report Form
Ref: RI/QMS/SOP/012b Identifying & preventing noncompliance with Good Clinical Practice or the protocol
Ref: RI/QMS/SOP/012c : Protocol Deviation Review & Analysis Form

Ref: RI/QMS/SOP/013 : R&I Safety Reporting
Ref: RI/QMS/SOP/014 : R&I Monitoring
Ref: RI/QMS/SOP/015 : R&I Computer System Validation & Backup
Ref: RI/QMS/SOP/016 : R&I Research Contracts & Vendor Selection
Ref: RI/QMS/SOP/017 : R&I Data Management
Ref: RI/QMS/SOP/018: R&I Management of Fridges & Freezers
Ref: RI/QMS/SOP/019 : R&I RESTART During urgent public health emergencies
Ref: RI/QMS/SOP/020 : Management of healthy volunteers in research
Ref: RI/QMS/SOP/021 : R&I Informed Consent in Adult Research Setting

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Contact Research

Research & Development
North Bristol NHS Trust
Level 3, Learning & Research building
Southmead Hospital
Bristol, BS10 5NB

Telephone: 0117 4149330

Research Policies & Forms