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Safety Reporting Guidance
There are separate safety reporting procedures for use in:
Clinical Trials of Investigational Medicinal Products
The Central Office of Research Ethics Committees website contains guidance on the Safety Reporting Process for CT IMPs
For further guidance on safety reporting procedures, please refer to the Safety Reporting section of the Clinical Trials Toolkit
Please note that there are specific timeframes within which to report any Suspected Unexpected Serious Adverse Reactions (SUSARs). A SUSAR which is fatal or life-threatening must be reported as soon as possible and in any event within 7 days after the sponsor became aware of the event. Any additional information must be reported within eight days of sending the first report. A SUSAR which is not fatal or life-threatening must be reported as soon as possible and in any event within 15 days after the sponsor became aware of the event.
Please send a copy of CT IMP safety reports to the following:
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Main REC that provided a favourable opinion – REC contact details
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Research Sponsor – where LTHT/UoL is the sponsor, please send documentation to the R&D Department
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Competent Authority – MHRA
LTHT Requirements
Any adverse events/adverse drug reactions must be reported to the appropriate research ethics committee, research sponsor and any other regulatory authority.
If you have any doubt, please contact your Sponsor.
All other research
Research Ethics Committee
Requirements
Please refer to the Central Office of Research Ethics Committee website for guidance on the reporting process for all other research
Please send a copy of safety reports to:
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Main REC that provided a favourable opinion – REC contact details
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Research Sponsor – where LTHT/UoL is the sponsor, please send documentation to the R&D Department
Please consult the your research protocol for guidance.