23rd Oct 2015, 12:43 PM
SUSARs sent to pharmacies
If a pharmacy in a clinical trial requires an IB to be filed in their pharmacy file, my understanding is that they should also receive all new safety information (e.g. SUSARs) in order to ensure they have up to date information, is this correct? Most pharmacies do not want this; is it adequate enough for the SUSARs to be sent to the PI and maintained in the site master file, even if the pharmacy is at a different location to the Investigational site?