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21st Jul 2015, 12:00 PM
#1
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?
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