[Anonymous]

Reply To: Trial Site temperature control – audit findings

We have a check list that the site must comply to at the time of site qualification visit prior to the study start, and the site is required to have a qualified temp monitor to monitor the IP; then, after the study is on-going, the site MUST (quarantine the IP physically and in IRT) report any temperature excursion so generally it is rare for an audit finding with issues with site monitoring of IP.