Sponsor Responsibilities

Question 1

How long does the sponsor have to submit an annual report to the FDA

Answer 1

60 days from the anniversary date of the IND approval

Question 2

If the fda proposes termination of an IND The sponsor may provide in writing corrective action or explanation within how many days

Answer 2

30 days

Question 3

If the FDA does not accept the sponsor’s corrective action or explanation to prevent termination of an IND the sponsor may request a regulatory meeting within how many days of receiving fda’s notification of non acceptance

Answer 3

10 days

Question 4

The sponsor must maintain accurate records Of drug shipments investigators financial interests the sponsors financial interests for how long after Market apprevil or last shipment of drug

Answer 4

2 years

Question 5

How often does the sponsor have to provide progress reports to the fda

Answer 5

Annually

Question 6

IDE monitoring requirements for sponsor

Answer 6

Insure investigator compliance with plan and regs.
Must review unanticipated device effects

Question 7

Sponsors device use termination determination 2/2 UADE to be reported to investigators, IRBs, and FDA within ______ days but no more than ______days after event occurs.

Answer 7

UADE that present unreasonable risk, may be cause for termination of some or all of the investigation. Termination to be made with 5 working days of determination but no more than 15 days after UADE.
May not be reinstated without IRB and/or FDA approval depending on device type.

Question 8

In the case of IDE withdrawal sponsor to notify

Answer 8

All IRBs, FDA, and investigators within 5 working days.

Question 9

Sponsor to provide FDA with list of investigators participating in study every

Answer 9

6 months

Question 10

Recalled or returned devices must be disclosed to fda and irb within

Answer 10

30 working days and disclose the reason for return or recall.

Question 11

For significant risk devices, Sponsor to notify fda with _____ of study completion and provide final report within ________.

Answer 11

30 days
6 months

Question 12

Device use without informed consent must be reported to IRB and sponsor within

Answer 12

5 working days

Question 13

If irb determines a device is significant risk when the sponsor thought it was NSR, this must be reported to the fda within

Answer 13

5 working days

Question 14

Sponsor may request fda waiver if

Answer 14

1. Statement of why requirement is unnecessary
2. Description of alternate actions to satisfy requirement
3. If noncompliance will not cause significant or unreasonable risk
4. Compliance is unachievable or not needed due to type of study.

Question 15

If FDA grants emergency expanded access the MD or sponsor must submit expanded access submission within:

Answer 15

15 working days of FDA authorization