For CTIMPs and projects involving complex procedures, a project-specific risk assessment must be performed and documented either within the protocol or within a separate risk assessment document for all clinical research.
For low-risk projects a statement may be included within the protocol to include an explanation that the project was assessed as being low risk or of comparable risk to standard of care.
Where the risk assessment is a separate document, this should be referenced in the protocol. RGT may request a copy of the risk assessment at sponsor review.
The risk-assessment will need to be reviewed during the lifetime of the project in particular where there are any substantial amendments made to the project or regulatory changes that could impact the project.
Please seethe UoB Project Oversight & Quality Management SOP (UoB-POS-SOP-001) (Word - 145 KB) for further details on carrying out a risk assessment. A Risk Assessment Template (UoB-CLN-TQM-QCD-001) is also available*.
* This document is currently under review and the link this document has temporarily been removed. If you wish to access it, please contact the Clinical Research Compliance Team at firstname.lastname@example.org.