Important timelines Flashcards
If informed consent is not feasible and the investigator does not have enough time to consult, how long do they have to get the decision reviewed and evaluated by an outside physician?
5 working days
If informed consent is not feasible, how long does the investigator have to submit documentation to the IRB?
5 working days
When does emergency use of a test article need to be reported to the IRB?
5 working days
How often does IRB registration need to be renewed?
Every 3 years
How quickly does an IRB need to submit changes to contact or chair person’s information?
90 days
How quickly does an IRB need to report its decision to review new types of FDA-regulated products OR discontinue reviewing clinical investigations regulated by the FDA?
30 days
How quickly does an IRB need to report its decision to disband?
30 days after permanent cessation of IRB’s review of research
How often shall an IRB conduct a continuing review of research?
At least once a year, more if the level of risk requires it.
How long should an IRB keep required records?
3 years, need to be accessible by the FDA
How often should information amendments to the IND be submitted?
As necessary, but not more than once every 30 days
How quickly should an IND safety report be submitted to the FDA?
ASAP, no later than 15 calendar days
When does additional information requested by the FDA for an IND safety report need to be submitted?
ASAP, no later than 15 calendar days
When does the sponsor need to notify the FDA of an unexpected, fatal, or life threatening suspected adverse reaction by?
ASAP, no later than 7 calendar days
When should an annual report be submitted for an IND?
Within 60 days of the anniversary date the IND went into effect
How long does the ICH require the sponsor retain essential documents for after the last approval of a marketing application in an ICH region and until there are no pending or contemplated marketing applications in an ICH region?
At least 2 years
