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 check the website regularly to see if SOPs have been added or amended.

If you have any questions, comments or concerns about these documents, please get in touch with us via research@nbt.nhs.uk.

Policies & Guidance

Study Development

Study Set-Up

Standard Operating Procedures

Ref: RI/QMS/SOP/001
R&I – Preparation Of Research

Ref: RI/QMS/SOP/002
R&I – Obtaining R&I Confirmation For Research To Start

Ref: RI/QMS/SOP/003
R&I – Research Study Amendments

Ref: RI/QMS/SOP/004
R&I – Maintenance Of Research Equipment

Ref: RI/QMS/SOP/005
R&I – Research Staff Training

Ref: RI/QMS/SOP/006
R&I – Honorary Research Contract Letters of Access
External Researcher Information Form (006a)

Ref: RI/QMS/SOP/007
R&I – Applying For NBT Sponsorship
Sponsorship Request Form (007a)
NBT Terms Of Sponsorship (007b)
Delegation Of Responsibilities (007c)
Delegation Of Responsibilities (007d)
Declaration Form (007e)

Ref: RI/QMS/SOP/008
R&I – Writing A Protocol For ctIMPs

Ref: RI/QMS/SOP/009
R&I – Periodic Reporting To The REC And MHRA
DSUR Template (009a)

Ref: RI/QMS/SOP/010
R&I – 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
ICH GCP Protocol Noncompliance Report Form (012a)
Identifying And Preventing Noncompliance With Good Clinical Practice Or The Protocol (012b)
Protocol Deviation Review & Analysis Form (012c)

Ref: RI/QMS/SOP/013
R&I – Safety Reporting: ctIMPs
SAE/SAR/SUSAR Initial Report Form – ctIMPs (013a)
SAE/SAR/SUSAR Follow-Up Report Form – ctIMPs (013b)
Safety Reporting: Non-ctIMPs (013c)
SAE/SAR Initial Report Form – Non-ctIMPs (013d)
SAE/SAR Follow-Up Report Form – Non-ctIMPs (013e)

Ref: RI/QMS/SOP/014
R&I – Monitoring
Preparation Of A Monitoring Plan (014a)

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 R&I Fridges And Freezers

Ref: RI/QMS/SOP/019
R&I – RESTART During Urgent Public Health Emergencies

Ref: RI/QMS/SOP/020
R&I – Management of Healthy Volunteers In Research

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Contact Research & Innovation

Research & Innovation
North Bristol NHS Trust
Floor 3, Learning & Research Centre
Southmead Hospital
Westbury-on-Trym
Bristol, BS10 5NB

Telephone: 0117 4149330
Email: research@nbt.nhs.uk

Research Policies & Forms