Reporting Timeframes

Question 1

How long must the IRB keep correspondence after the completion of a clinical trial?

Answer 1

3 years

Question 2

How long do Essential documents have to be retained?

Answer 2

2 years

after the last approval of a marketing application in an ICH region

until there are no pending or contemplated marketing applications in an ICH region

at least 2 years have elapsed since formal discontinuation of clinical development of the IP

Question 3

How long does the FDA have to review an IND?

Answer 3

30 days

Question 4

How long does the FDA have to approve an NDA?

Answer 4

Within 180 days after NDA filing

Question 5

What is the reporting time frame fora serious and fatal or life-threatening AE reported by investigator to sponsor?

Answer 5

7 days

Question 6

What is the reporting time frame for a serious and not fatal or life-threatening AE reported by investigator to sponsor?

Answer 6

15 days

Question 7

What is the reporting time frame for a UAP discovery and IRB notification?

Answer 7

2 weeks or 10 business days

Question 8

What is the reporting time frame for acquiring or discovering a significant financial interest (SFI) and submitting an updated disclosure to the institution?

Answer 8

30 days