Reporting timelines

Question 1

Fatal or life-threatening unexpected adverse drug reactions

Answer 1

7 calendar days

Question 2

Non-life threatening unexpected ADRS

Answer 2

15 calendar days

Question 3

Serious unexpected safety events when non-life threatening

Answer 3

15 calendar days (sponsor to FDA)

Question 4

Serious unexpected life-threatening safety events

Answer 4

7 calendar days (sponsor to FDA)

Question 5

Emergency use of device or drug, where immediate use of product was required and patient was not able to consent

Answer 5

5 working days (sponsor to IRB and FDA)

Question 6

IDE unexpected adverse device event

Answer 6

10 working days (sponsor to FDA)

Question 7

Serious risk IDE notification of trial completion

Answer 7

30 working days (sponsor to FDA)

Question 8

Annual report from sponsor to FDA

Answer 8

within 60 calendar days of anniversary

Question 9

IRB Registration renewal

Answer 9

Every 3 years

Question 10

Changes in IRB registration

Answer 10

within 90 days of change

Question 11

IRB discontinuing review of clinical investigations

Answer 11

30 working days of IRB cessation

Question 12

PI response to FDA Form 482 and 483

Answer 12

15 days (PI to auditors)

Question 13

Expanded access IND effect day after FDA receipt

Answer 13

30 days (or earlier)

Question 14

Sponsor retention time for records and reports per 21 CFR Part 312 after marketing application is approved

Answer 14

2 years

Question 15

Sponsor retention of foreign clinical study not conducted under IND

Answer 15

2 years

Question 16

Study is inactivated after how many years for no SUBJECT enrollment?

Answer 16

2 years

Question 17

Study is inactive after how many years of a clinical hold?

Answer 17

1 year

Question 18

Study is inactive for how long after IND that remains in active for?

Answer 18

5 years for termination

Question 19

How long for financial disclosures after completion of study?

Answer 19

1 year

Question 20

How long should investigator or sponsor hold records after study is terminated or completed or not required for premarket approval application

Answer 20

2 years

Question 21

Sponsor notification to FDA for termination or completion of study?

Answer 21

30 working days

Question 22

Investigator report to sponsor of withdrawal or approval by IRB within?

Answer 22

5 working days

Question 23

Final report from investigator to sponsor and IRB?

Answer 23

3 months after termination