IMP temp monitoring

[susie]

Thanks John yes it is crazy that new thermometers cost less isnt it.

[CTU]

It's also worth being aware that most medications can be stored at up to 30 degrees even if the SmPC says 25 degrees. That knocks out many of the problems and one should request approval for up to 30 degrees in the SmPC.

How important this is should also surely depend on the study rather than being an arbitrary rule? It's a nonsense to waste time temperature monitoring wards for a few days at the start of a trial if you're dealing with a drug that has been on the market for 40 years and where each patient is dosed over 18 months - whereas a novel compound given for only 7 days while an inpatients might be important to monitor closely.

I don't understand why the risks of temperature excursions cannot be debated and agreed at study start and protocols written to say it will be ignored completely in low risk situations or study designs.

Has anyone seen that done? How would the MHRA feel about that? Perhaps it should form part of the CTA application?

CTU

[pgamble]

On the note of thermometers - we have recently bought electronic data loggers for temperature and I have checked with the MHRA regarding 're-calibration'. For non-trial loggers we usually get one logger externally recalibrated then use that one to 'validate' the use of the others in the department therefore getting around paying for recalibration of all loggers. I have been assured by the MHRA CT helpline that this is fine to do for loggers used for clinical trial stock :-) another cost saving for R&D and the NHS!!!

[skumar]

Hi pgamble,
We are in similar situation.New web based system installed in Pharmacy.As backup system can we calibrate min/max thermometer? Some of these thermometers are due calibration next month and some are due next year.Can we calibrate Min/max thermometers using one which are due next year or we need to calibrate using a brand new calibrated thermometer?

[Chris H]

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.

[ilyas ali]

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.

[ilyas ali]

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.........

[CTU]

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!!