Pharmacovigilance

CPTU ensures that all issues relating to patient safety adhere to the strict legal requirements in this area by carrying out the following activities:

• advising on how adverse events should be detailed in the protocol
• designing CRFs to capture all the relevant information on adverse events
• providing centres with written procedures on how to record and report adverse events
• monitoring clinical sites to check that safety is being properly reported
• organising a Data Monitoring Committee to regularly assess safety
• alerting principal investigators to important safety issues which may occur during the trial
• managing all aspects of safety reporting to the relevant authorities