Requirement of temperature data before dosing [Study Performance]
❝ Storage condition is to store product between 15-30 degree centrigrade
If you are not sure the IMP was stored within the storage recommendation interval, or that any deviations do not affect the quality (/safety/efficacy) then you should probably not dose any subjects with it. Storage conditions exist for a reason.
Quarantine the IMP, contact the sponsor to get a statement from the release office or QP. All this is likely a part of your QMS already.
Pass or fail!
- Requirement of temperature data before dosing anky1212 2017-07-20 08:08
- Requirement of temperature data before dosing Ohlbe 2017-07-20 09:57