Record Retention

Question 1

The IRB/IEC should retain all relevant records…

Answer 1

For at least 3 years after completion of the trial

Question 2

Investigator essential documents should be retained…

Answer 2

• 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

Question 3

IRB must renew registration

Answer 3

Every 3 years

Question 4

Health Canada retains records for…

Answer 4

25 years

Question 5

A sponsor shall retain the records and reports for…

Answer 5

• 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.