Good Clinical Practice Guide
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Thread: IMP temp monitoring

  1. #11
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    Nov 2011
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    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.

  2. #12
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    Hi All,

    My understanding about importance of temperature monitoring is that, as the product is in investigation use, every single thing they take as serious. And I think that if MHRA is linear with temperature control then people might misuse that phrase and start storing at any places.

  3. #13
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    Dear skumar,

    It might not be a good idea to use any thermometer to use as reference point. Normally this responsibilities lies with QC department. If you want to calibrate some thermometer, you must have one reference thermometer which normally calibrated by manufacturer. Using that manufacturer calibrated thermometer you can calibrate other thermometers.........

  4. #14
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    Jan 2012
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    Just realised in my post above I should have said apply for 30 degrees in the CTA application even if the SmPC says store at 25 degrees, not to apply for 30 degrees in the SmPC....obviously!!

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