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Important new operating procedures for Ïã¸ÛÁùºÏ²Ê-sponsored CTIMPs

6 February 2012

The Ïã¸ÛÁùºÏ²Ê standing operating procedure (SOP) for reporting adverse events has been updated and Ïã¸ÛÁùºÏ²Ê-sponsored CTIMP investigators are advised to make sure their staff are trained in it.

The updated version of the Ïã¸ÛÁùºÏ²Ê SOP for the recording management and reporting of adverse events by investigators is JRO/INV/S05/04 and can be downloaded from the .

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.