Record Retention Flashcards
(5 cards)
The IRB/IEC should retain all relevant records…
For at least 3 years after completion of the trial
Investigator essential documents should be retained…
- 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
IRB must renew registration
Every 3 years
Health Canada retains records for…
25 years
A sponsor shall retain the records and reports for…
- 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.