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 be accessed via the 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 the SOPs.

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 comments or suggestions, please contact Research@nbt.nhs.uk.

Reference	SOP	Supporting Documents
RI/QMS/SOP/001	Preparation of Research SOPs.pdf	No supporting documents for these SOPs
RI/QMS/SOP/002	Obtaining R&I Confirmation for Research to Start.pdf
RI/QMS/SOP/003	Research Study Amendments.pdf
RI/QMS/SOP/004	Maintenance of Research Equipment.pdf
RI/QMS/SOP/005	RI QMS SOP 005 - Research Staff Training.pdf
RI/QMS/SOP/006	Honorary Research Contracts & Letters of Access.pdf	External Researcher Information Form.doc
RI/QMS/SOP/007	Applying for NBT Sponsorship.pdf	Sponsorship Request Form.doc
		NBT Terms & Conditions of Sponsorship.pdf
		Delegation of Responsibilites.pdf
		Delegation of Responsibilities Log.doc
		Chief Investigation Declaration Form.pdf
RI/QMS/SOP/008	Writing a Protocol for CTIMPs.pdf	No supporting documents for this SOP
RI/QMS/SOP/009	Periodic Reporting to the REC and MHRA.pdf	DSUR Template.doc
RI/QMS/SOP/010	Archiving.pdf	No Supporting documents for these SOPs
RI/QMS/SOP/011	Closing, Suspending, and Terminating Research.pdf
RI/QMS/SOP/012	Managing Breaches of Good Clinical Practice or the Protocol.pdf	ICH GCP & Protocol Non-compliance Report Form.doc
		Identifying and Preventing Non-Compliance with GCP or the Protocol.pdf
		Protocol Deviation Review and Analysis Form.doc
RI/QMS/SOP/013	Safety Reporting: CTIMPs.pdf	SAE/SAR/SUSAR Initial Report Form - CTIMPs.doc
		SAE/SAR/SUSAR Follow Up Report Form - CTIMPs.doc
		Safety Reporting: Non-CTIMPs.pdf
		SAE/SAR Initial Report Form - Non-CTIMPs.doc
		SAE/SAR Follow Up Report Form - Non-CTIMPs.doc
RI/QMS/SOP/014	Monitoring.pdf	Preparation of a Monitoring Plan.pdf
RI/QMS/SOP/015	Computer System Validation & Backup.pdf	No Supporting documents for these SOPs
RI/QMS/SOP/016	Vendor Management.pdf
RI/QMS/SOP/017	Data Management.pdf
RI/QMS/SOP/018	Management of R&I Fridges and Freezers.pdf
RI/QMS/SOP/019	RESTART During Urgent Public Health Emergencies.pdf