Timelines Flashcards
How many days does a sponsor have to report an emergency use of an IP to the FDA
5 WD
How long must an IRB retain records per 21 CFR 56
3 years after completion of research
How many days does the IRB have to report a change in registration info due to a change in chairperson or contact?
90
How many days does an IRB have to inform the FDA that it is reviewing different types of FDA products?
30
How oftem must an IRB renew its registration
3 years
Sponsors must report SAEs to the FDA within how many days of discovering the event?
15 calendar days
Investigators must report SAEs toa sponsor within how many days of discovering the event?
immediately
Sponsors must report what kind of serious events to the FDA within 15 calendar days?
- serious and unexpected AR
- Findings from other studies that suggest a significant risk in humans
- Findings from animal or in-vitro testing that suggest risks to humans
- increased rate of occurrence of serious suspected ARs
Sponsors must submit unanticipated adverse device effects to the FDA within how many days?
10 WD
Investigator retains study records for ____ years after date a marking application is approved for indication for which it was investigated or for _____ years after an investigator was discontinued and FDA notified
2 years 2 years
How many day sdoes a sponsor have to submit a report to the FDA/ investigators/IRBs aout withdrawal of IRB approval
5wd
How many days does a sponsor have to submit a report to investigators/IRB about withdrawal of FDA approval
5wd
How many days does a sponsor have to submit a report to FDA/ Investigators/ IRB about returns, repairs or disposal of units of a device?
notive to be provided within 30 days
How many days does a sponsor have to submit a report to FDA about SR DEVICE IF SPONSOR SUGGESTED NSR
5WD
wwhen must a sponsor submit a brief report of investigation progress to FDA for drug trials
within 60 days of anniversary date that IND went into effect