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Question 1

Form 3500 vs 3500A vs 3500B

Answer 1

3500 – form for voluntary submission by a health care professional with concerns about FDA-regulated product

3500A is used for mandatory reporting of medical device adverse events by manufacturers, user facilities and importers.

3500B – form for voluntary reporting
by a consumer

Question 2

For IND, the sponsor shall discontinue the investigation that poses unneccessary, significant risk as soon as possible, and in no event later than

Answer 2

5 days

Question 3

For a significant risk device, the sponsor must notify FDA and all reviewing IRBs within …..days of the completion or termination of the investigation.

Answer 3

30 days

Question 4

Adverse reaction reporting requirements by sponsor under 312

Answer 4

Serious: 7 days
Otherwise 15 days

Question 5

An investigator must report to the sponsor any serious adverse event, whether or not considered drug related, including those listed in the protocol or investigator brochure

Answer 5

Immediately

Investigator must include an assessment of whether there is a reasonable possibility that the drug caused the event.

Question 6

Under 21 CFR 812, the sponsor who conducts an evaluation of an unanticipated adverse device effect ) shall report the results of such evaluation to…..within … working days after the sponsor first receives notice of the effect.

Answer 6

1) FDA and to all reviewing IRB’s and participating investigators

2) 10

Question 7

In 21 CFR 812.150(a)(1), the researcher is required to submit reports of unanticipated adverse device effects to the IRB and the sponsor

Answer 7

“as soon as possible”, but in no event later than 10 working days

Question 8

Does “statement of new findings provided to subjects” needs to be retained by IRB?

Answer 8

Yes