Reporting timelines Flashcards
Fatal or life-threatening unexpected adverse drug reactions
7 calendar days
Non-life threatening unexpected ADRS
15 calendar days
Serious unexpected safety events when non-life threatening
15 calendar days (sponsor to FDA)
Serious unexpected life-threatening safety events
7 calendar days (sponsor to FDA)
Emergency use of device or drug, where immediate use of product was required and patient was not able to consent
5 working days (sponsor to IRB and FDA)
IDE unexpected adverse device event
10 working days (sponsor to FDA)
Serious risk IDE notification of trial completion
30 working days (sponsor to FDA)
Annual report from sponsor to FDA
within 60 calendar days of anniversary
IRB Registration renewal
Every 3 years
Changes in IRB registration
within 90 days of change
IRB discontinuing review of clinical investigations
30 working days of IRB cessation
PI response to FDA Form 482 and 483
15 days (PI to auditors)
Expanded access IND effect day after FDA receipt
30 days (or earlier)
Sponsor retention time for records and reports per 21 CFR Part 312 after marketing application is approved
2 years
Sponsor retention of foreign clinical study not conducted under IND
2 years
Study is inactivated after how many years for no SUBJECT enrollment?
2 years
Study is inactive after how many years of a clinical hold?
1 year
Study is inactive for how long after IND that remains in active for?
5 years for termination
How long for financial disclosures after completion of study?
1 year
How long should investigator or sponsor hold records after study is terminated or completed or not required for premarket approval application
2 years
Sponsor notification to FDA for termination or completion of study?
30 working days
Investigator report to sponsor of withdrawal or approval by IRB within?
5 working days
Final report from investigator to sponsor and IRB?
3 months after termination
