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e-Pathway: Study Management
Adverse Events & Deviations
Last updated on 4 November 2024
Clinical evaluation of SAEs
Clinical evaluation of SAEs
The researcher should ensure that site staff are appropriately trained to record and assess adverse events. The recording and reporting requirements of adverse events will need to be decided and documented within the protocol on an individual project basis.
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See UoB Adverse Event Reporting SOP (UoB-AES-SOP-001) [Word - 212 KB]
Documented evidence of the recording and reporting process should be retained, and projects may wish to develop a project-specific serious adverse event (SAE) form:
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See UoB Serious Adverse Events (SAE) Form Template QCD (UoB-AES-QCD-001) [Word - 311 KB]
- See also 'Reporting Requirements' in the Project Management - Quality & Oversight section of the e-Pathway.
Unexpected & related SAEs/SUSARs processing
Unexpected & related SAEs/SUSARs processing
It is important that adverse events are reported appropriately and in line with regulatory requirements. Depending on the type of project, the procedures for safety reporting and the regulatory timeframe for reporting will differ and the protocol will include appropriate information. In addition, please refer to the UoB Adverse Event Reporting SOP (UoB-AES-SOP-001) [Word - 212 KB].
The safety reporting page of the HRA website has further details on safety reporting for clinical research. Effective as of the 1st Aug 2024, the HRA have also updated the process for how they acknowledge SUSARs, further guidance is available via 'Important changes to progress reports and safety reports’ link.
Serious breach reporting
Serious breach reporting
In the case of any unexpected serious events that might impact participant safety or data integrity (for example any breaches of protocol), please contact the Research Governance Team via researchgovernance@contacts.bham.ac.uk as soon as possible. The Team will need the details of the event that occurred and the corrective / preventative actions that have been taken or will be put into place. The Team will assist with reporting needs.
Please see the UoB Deviations & Serious Breach Reporting SOP (UoB-DSB-SOP-001) (Word - 74 KB) for more information.
For UoB CTU-managed trials, please refer to internal CTU procedures.