A clinical trial sample cannot be taken again, so two things are protected together in transport: the sample's temperature and the record that tells its story. The protocol writes the conditions. ICH E6(R3) expects the protocol to document the collection, chain of custody, processing, analysis and retention or destruction of biological samples, and lists documentation of collection, processing and shipment of samples and of their storage conditions among the essential records.
| On the shipment form | What goes in |
|---|---|
| Protocol and sample | Protocol version, coded sample ID, sample type |
| Time | Collection and planned processing time |
| Packaging | Packaging and cold-source configuration, storage condition from the protocol |
| Record | Logger ID, raw data |
| Chain of custody | Giver, receiver and time at every handover |
After a delay, logger alarm, damaged packaging or handover mismatch, write down the time and the action taken in the field, leave the raw data unchanged and hold the sample under the protocol's deviation route. The field team does not decide whether it goes to analysis; that decision belongs to the study and laboratory staff the protocol authorises.