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23rd May 2012, 11:54 AM
#10
Good post CTU - I think the MHRA are very reasonable in their expectations for IMP temp monitoring when the risks of not temp monitoring are demonstrably very low. We have a CTIMP running in which the IMP is a well established drug dispensed as per routine practice from hospital stock and used in it's licensed indication. We stated in the protocol and in the CTA application that the IMP will be stored as per routine practice; we don't maintain any temperature logs as part of the trial documentation therefore. That said, the trial is very much a 'Type A' trial.
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