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 firstname.lastname@example.org.
Policies & Guidance
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.
Standard Operating Procedures
R&I – Preparation Of Research
R&I – Obtaining R&I Confirmation For Research To Start
R&I – Research Study Amendments
R&I – Maintenance Of Research Equipment
R&I – Research Staff Training
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)
R&I – Writing A Protocol For ctIMPs
R&I – Periodic Reporting To Regulatory Authorities
DSUR Template (009a)
R&I – Archiving
R&I – Closing, Suspending And Terminating Research
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)
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)
R&I – Computer System Validation & Backup
R&I – Research Contracts & Vendor Selection
R&I – Data Management
R&I – Management of R&I Fridges And Freezers
R&I – RESTART During Urgent Public Health Emergencies
R&I – Management of Healthy Volunteers In Research
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