Reporting Timelines Flashcards
How long Does the sponsor have to notify the FDA and all participating investigators of POTENTIAL serious risks
15 calendar days from determination
How long does the sponsor have to notify the FDA of any unexpected fatal or life-threatening suspected adverse reactions
7 calendar days
A serious adverse event That is determined at a later date To be reportable to the fda must be submitted within
15 calendar days
If the sponsor finds the drug presents unreasonable or significant risk to subjects they will discontinue all investigations notify the FDA and all clinical investigators and IR b’s within how many working days
Notification must be made within 5 working days of determination
How long does the investigator have to respond the Form 483
15 days
Investigators must notify sponsors, and Sponsors must report UADEs to FDA and IRBs within
10 working days
