Important new operating procedures for ¹û¶³Ó°Ôº-sponsored CTIMPs
6 February 2012
The ¹û¶³Ó°Ôº standing operating procedure (SOP) for reporting adverse events has been updated and ¹û¶³Ó°Ôº-sponsored CTIMP investigators are advised to make sure their staff are trained in it.
The updated version of the ¹û¶³Ó°Ôº 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.