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Important new operating procedures for UCL-sponsored CTIMPs
6 February 2012
The UCL standing operating procedure (SOP) for reporting adverse events has been updated and UCL-sponsored CTIMP investigators are advised to make sure their staff are trained in it.
The updated version of the UCL SOP for the recording management and reporting of adverse events by investigators is JRO/INV/S05/04 and can be downloaded from the web page for UCL-sponsored CTIMPs SOPs.
This SOP replaces the version JBRU/INV/S05/03 which should now be archived. Investigators are asked to read the SOP and make sure their staff are trained it.
The last page of the SOP is a signature log which needs to be filled in to demonstrate to monitors/auditors/MHRA inspectors that you are aware of the Pharmacovigilance process: Event assessment, recording and reporting.
If you have any queries please contact Farhat Gilani, the JRO Senior Pharmacovigilance Coordinator on f.gilani@ucl.ac.uk.
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