Reply To: EU guideline on shipping and temp monitoring (536/2014)
April 11, 2023 at 1:14 pmHi, something to consider as well. Smart packaging (electronic tag and printed sensor) tracks adherence to the prescribed medication by recording date, time and dose location for each unit-dose removed from the blister card/wallet; providing a unique ID # per cavity for IMP traceability. If you include this in your trial design there is an optional temperature tracking feature -25°C to 75°C (5°F to 149°F). This way as the participant goes to take the medication from the blister card/wallet, a simple scan (tap) using their smartphone will indicate whether or not the drug is save to use. Once safe, the participant takes the drug which is also tracked and marked as adherent or non-adherent.
