Record Retention Flashcards
(5 cards)
1
Q
The IRB/IEC should retain all relevant records…
A
For at least 3 years after completion of the trial
2
Q
Investigator essential documents should be retained…
A
- At least 2 years after last approval of marketing application in ICH region
- Until there are no pending marketing applications
- At least 2 years have elapsed since formal discontinuation of product
3
Q
IRB must renew registration
A
Every 3 years
4
Q
Health Canada retains records for…
A
25 years
5
Q
A sponsor shall retain the records and reports for…
A
- 2 years after a marketing application is approved for the drug OR
- 2 years after shipment and delivery of the drug for investigational use is discontinued and FDA has been so notified.
