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

PDF icon Preparation of Research SOPs.pdf

No supporting documents for these SOPs

RI/QMS/SOP/002

PDF icon Obtaining R&I Confirmation for Research to Start.pdf

RI/QMS/SOP/003

PDF icon Research Study Amendments.pdf

RI/QMS/SOP/004

PDF icon Maintenance of Research Equipment.pdf

RI/QMS/SOP/005

PDF icon 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

PDF icon Applying for NBT Sponsorship.pdf

File Sponsorship Request Form.doc

PDF icon NBT Terms & Conditions of Sponsorship.pdf

PDF icon Delegation of Responsibilites.pdf

File Delegation of Responsibilities Log.doc

File Chief Investigation Declaration Form.pdf

RI/QMS/SOP/008

PDF icon Writing a Protocol for CTIMPs.pdf

No supporting documents for this SOP

RI/QMS/SOP/009

PDF icon Periodic Reporting to the REC and MHRA.pdf

File DSUR Template.doc

RI/QMS/SOP/010

Archiving.pdf

No Supporting documents for these SOPs

RI/QMS/SOP/011

Microsoft Office document icon Closing, Suspending, and Terminating Research.pdf

RI/QMS/SOP/012

PDF icon Managing Breaches of Good Clinical Practice or the Protocol.pdf

Microsoft Office document icon ICH GCP & Protocol Non-compliance Report Form.doc

PDF icon Identifying and Preventing Non-Compliance with GCP or the Protocol.pdf

File 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

PDF icon Monitoring.pdf

PDF icon Preparation of a Monitoring Plan.pdf

RI/QMS/SOP/015

PDF icon Computer System Validation & Backup.pdf

No Supporting documents for these SOPs

RI/QMS/SOP/016

PDF icon Vendor Management.pdf

RI/QMS/SOP/017

PDF icon Data Management.pdf

RI/QMS/SOP/018

PDF icon Management of R&I Fridges and Freezers.pdf