21st Jul 2015, 12:00 PM
Temp controlled storage of IMP - Provision of Temperature logs by site
We are setting up a study with a new site. The study requires temperature controlled storage of the IMP and the site has a good system in place for monitoring storage temperature but they tell us they will not provide printed temperature logs for out ITMF and STMF as this out of compliance with their own SOP and we are unusual in requesting these documents, no other sponsors do!
Almost all our IMPs need temperature controlled storage and we use sites across the whole UK and no other site has refused to provide these logs. If this site refuses to provide logs, how else can we evidence the IMP has been correctly managed during storage?
4th Aug 2015, 04:31 PM
Can the temperature logs be reviewed during on-site monitoring instead? Then you can check they exist and confirm no deviations noted.
10th Aug 2015, 01:35 PM
We can do that but we will not be given any evidence from site that this is the case during or after the study
22nd Jan 2016, 05:39 PM
What sort of SOP are they quoting that prohibits them from providing documented evidence that they have taken appropriate care of somebody else's property?
What happens when the trial master file is audited several years down the track, when their temperature monitoring system has been superseded and they can no longer retrieve historical data?
Speaking from the QP/GMP auditor perspective that sort of response aks me wonder what else they might make difficult to prove?