Reporting Timelines

Question 1

Within how many days must fatal or life-threatening unexpected adverse drug reactions must be reported?

Answer 1

7 calendar days

Question 2

Within how many days must a non-life threatening unexpected ADR must be reported?

Answer 2

15 calendar days

Question 3

Within how many days must the sponsor report serious unexpected safety events when not life-threatening to the FDA?

Answer 3

15 calendar days

Question 4

Within how many days must sponsor submit an annual report to the FDA?

Answer 4

Within 60 calendar days of anniversary

Question 5

Within what timeframe must the sponsor submit the final report on non-SR IDE to IRB?

Answer 5

Within 6 months of finishing the trial

Question 6

Within what timeframe must the sponsor report final report on SR IDE to FDA and IRB?

Answer 6

Within 6 months of finishing the trial

Question 7

Within how many days should the sponsor report serious unexpected life-threatening safety events to the FDA?

Answer 7

7 calendar days

Question 8

Within how many days must sponsor report to IRB and FDA emergency use of a device or drug, where immediate use of the product was required and the patient was not able to be consented?

Answer 8

5 working days

Question 9

Within how many days must the investigator submit serious events to the sponsor?

Answer 9

ASAP - typically stated in protocol (24 hours)

Question 10

Within how many days should the sponsor notify the FDA of completion or termination of a SR IDE investigation?

Answer 10

30 working days

Question 11

Within what timeframe should the sponsor notify the IRB and participating investigators of completion or termination?

Answer 11

6 months

Question 12

Within how many days should the sponsor notify the FDA of an IDE unexpected adverse event?

Answer 12

10 working days

Question 13

How often should IRBs renew their registration?

Answer 13

Every 3 years

Question 14

An investigator needs to report to IRB within what time frame if there was an exception of informed consent to preserve the life of a subject

Answer 14

Within 5 working days of use

Question 15

Changes to IRB contact or chair person needs to be reported to the FDA within

Answer 15

90 days

Question 16

IRBs need to notify the FDA within what time frame if they are discontinuing investigations regulated by the FDA?

Answer 16

Within 30 days

Question 17

Sponsor needs to notify FDA within what time frame if a new investigator is added to the investigation?

Answer 17

30 days

Question 18

Sponsor needs to send IND safety reports to FDA & all investigators within what time frame?

Answer 18

15 days

Question 19

Sponsor must send FDA annual report within what time frame of the anniversary IND went into effect?

Answer 19

60 days

Question 20

Sponsor must submit IND safety follow up to FDA after they request within what timeframe?

Answer 20

15 days

Question 21

An IND will be placed on inactive status after how long on hold?

Answer 21

1 year

Question 22

If an IND has not had enrollment in what timeframe, will the FDA place it on inactive status?

Answer 22

2 years

Question 23

Within what timeframe can an inactive IND be terminated?

Answer 23

5 years

Question 24

Financial disclosure information must be kept up to date during the study and for how long after?

Answer 24

1 year

Question 25

If a sponsor discontinues a trial due to significant risks to subjects, sponsor needs to alert FDA, IRBs, and Investigators within what timeline?

Answer 25

5 working days

Question 26

How long should IRBs retain their records?

Answer 26

3 years

Question 27

How long should sponsors retain their records?

Answer 27

2 years

Question 28

How long should investigators retain their records?

Answer 28

2 years