Record Retention Flashcards
1
Q
How long after receiving FDA approval do PIs need to retain records?
A
2 years
2
Q
How long should PIs retain records after study completion?
A
2 years
3
Q
____ sponsors have to retain records for 2 years after approval
A
drug sponsors
4
Q
How long do records need to be retained after the last product shipment?
A
2 years
5
Q
A device study has been terminated or completed, what is done with the records?
A
They are retained for 2 years after termination or completion
6
Q
These records need to be kept for 3 years after termination or study completion.
A
IRB records
