Study close-out archiving issues

Australian regulations stipulate that records need to be retained for 15 years following the completion of a clinical trial, thus adhering to GCP. Investigational sites will often request financial support from the sponsor for offsite archiving by a third party.

Study close-out archiving issues

Australian regulations stipulate that records need to be retained for 15 years following the completion of a clinical trial, thus adhering to GCP. Investigational sites will often request financial support from the sponsor for offsite archiving by a third party.