Reply To: IMP Accountability in IRT & Returns/Destruction @ site


Pia Rudberg
Participant

Reply To: IMP Accountability in IRT & Returns/Destruction @ site

Hi. I am used to that site destruction is preferred, however, at study start sponsor/CRO must review the site destruction process and templates/documents used for traceability and documentation of the destruction itself, in order to ensure it is sufficient. If the process is not acceptable, returns must be arranged back to a depot for destruction. My experience is that this is often performed if the site cannot provide a proper destruction certificate/documentation of the destruction.