Record Retention Flashcards by madeline donnerstag

Q

How long after receiving FDA approval do PIs need to retain records?

A

2 years

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Q

How long should PIs retain records after study completion?

A

2 years

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Q

____ sponsors have to retain records for 2 years after approval

A

drug sponsors

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Q

How long do records need to be retained after the last product shipment?

A

2 years

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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

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Q

These records need to be kept for 3 years after termination or study completion.

A

IRB records

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