It was highlighted by the MHRA that pharmacy should be taking more responsibility for IMPs which are stored outside of pharmacy departments (i.e. on wards for inpatients, in Emergency Departments / ITU for emergency situations).
We've started looking at issues which may arise and have identified the following points to assess before and during the conduct of the trial:
1. Are ward staff (inparticular the ward managers) aware and happy that the IMP is being stored in the area?
2. Is the IMP stored securely with restricted access?
3. Is adequate temperature monitoring being performed (min / max on a daily basis using a calibrated thermometer)
4. Are IMPs being allocated correctly (e.g. randomisation numbers assigned in sequential order)?
Just wondering if anyone else had any other areas of concern?