Reporting Timelines Flashcards
Within how many days must fatal or life-threatening unexpected adverse drug reactions must be reported?
7 calendar days
Within how many days must a non-life threatening unexpected ADR must be reported?
15 calendar days
Within how many days must the sponsor report serious unexpected safety events when not life-threatening to the FDA?
15 calendar days
Within how many days must sponsor submit an annual report to the FDA?
Within 60 calendar days of anniversary
Within what timeframe must the sponsor submit the final report on non-SR IDE to IRB?
Within 6 months of finishing the trial
Within what timeframe must the sponsor report final report on SR IDE to FDA and IRB?
Within 6 months of finishing the trial
Within how many days should the sponsor report serious unexpected life-threatening safety events to the FDA?
7 calendar days
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?
5 working days
Within how many days must the investigator submit serious events to the sponsor?
ASAP - typically stated in protocol (24 hours)
Within how many days should the sponsor notify the FDA of completion or termination of a SR IDE investigation?
30 working days
Within what timeframe should the sponsor notify the IRB and participating investigators of completion or termination?
6 months
Within how many days should the sponsor notify the FDA of an IDE unexpected adverse event?
10 working days
How often should IRBs renew their registration?
Every 3 years
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
Within 5 working days of use
Changes to IRB contact or chair person needs to be reported to the FDA within
90 days
IRBs need to notify the FDA within what time frame if they are discontinuing investigations regulated by the FDA?
Within 30 days
Sponsor needs to notify FDA within what time frame if a new investigator is added to the investigation?
30 days
Sponsor needs to send IND safety reports to FDA & all investigators within what time frame?
15 days
Sponsor must send FDA annual report within what time frame of the anniversary IND went into effect?
60 days
Sponsor must submit IND safety follow up to FDA after they request within what timeframe?
15 days
An IND will be placed on inactive status after how long on hold?
1 year
If an IND has not had enrollment in what timeframe, will the FDA place it on inactive status?
2 years
Within what timeframe can an inactive IND be terminated?
5 years
Financial disclosure information must be kept up to date during the study and for how long after?
1 year
