Reporting Timelines

Question 1

A sponsor shall provide an annual report within ___ days of the anniversary date the IND activation.

Answer 1

60

Question 2

Unexpected fatal/life-threatening suspected ADR reports must be notified to FDA ___, but in no case later than ___

Answer 2

ASAP; 7 calendar days but most cases, protocol-specific

Question 3

Sponsor needs to report IND safety reports to FDA and investigators within ___

Answer 3

15 calendar days

Question 4

Grounds for termination of IND: If it remains ___

Answer 4

Inactive for 5 or more years.

Question 5

What are the two criteria for a IND to be inactive?

Answer 5

1) No enrollment within 2 years
2) On hold per FDA for 1 year

Question 6

Upon receiving rejection of IND, the sponsor needs to request for regulatory hearing within ___

Answer 6

10 days

Question 7

For an IND, when does the Investigator need to submit the final report to the sponsor?

Answer 7

No specific time constraints, can be contingent on sponsor request but should be completed following study completion

Question 8

For IDE, when does the sponsor need to report an unexpected adverse device event?

Answer 8

ASAP, in no event later than 10 working days after discovery.

Question 9

When IRB withdraws approval of the investigator, the investigator shall report to the sponsor within ___

Answer 9

5 working days

Question 10

How often are progress reports and what is the traffic for those communications?

Answer 10

Annual reports are the minimal expectation.
Twice a year for sig risk device studies.
Investigator -> Sponsor -> FDA

Question 11

For sig risk devices, sponsors shall notify FDA within ___ following study completion, and the final report should be submitted within ___

Answer 11

30 days; within 6 months

Question 12

Who communicates protocol deviations and what is the timeline of it?

Answer 12

The investigator shall report to sponsor ASAP but no later than 5 working days. The sponsor will then report to FDA if the deviation impacts study integrity.

Question 13

Devices utilized w/o ICF should be reported to sponsor and IRB within ___

Answer 13

5 working days

Question 14

For IDE, describe how final reports work: (NSR; 2)

Answer 14

1. Investigator complete detailed reports of findings, AEs, and etc per CRF guidelines and submit to sponsor within 3 months
2. Sponsor integrates investigator detailed reports from sites and preps for submission to FDA , usually within 6 months following study completion.

Question 15

How often do sites need to update current investigator list?

Answer 15

q6months

Question 16

Recall and device disposition: A sponsor shall notify FDA when an investigator returns/repairs any units of device and the notice shall occur within ___ after the request is made and should state the reason why:

Answer 16

30 working days

Question 17

If an IRB determines that a device is a sig risk device, despite initial proposal indicating otherwise, then the sponsor shall submit to FDA a report of the IRB’s decision within ___ after the sponsor first learns of the IRB’s determination.

Answer 17

5 working days

Question 18

How long do FDF be made for following study completion?

Answer 18

1 year

Question 19

After FDA receives IND or IDE, FDA must provide written determination to ___ within ___

Answer 19

Sponsor; 30 days

Question 20

FDA has ___ after receipt to respond to a sponsor request to lift an ___ hold.

Answer 20

30 days; IND

Question 21

Serious unexpected ARs (SADR) that are non-fatal must be filed ___ but no later than ___ after initial discovery.

Answer 21

ASAP; 7 calendar days

Question 22

For fatal/life threatening unexpected AEs, regulatory agencies should be notified ASAP to initiate consideration for ___. This must occur no less than ___ after discovery followed by a ____

Answer 22

Suspension or unexpected limitations of a protocol

7 calendar days

A complete report within 8 additional calendar days

Question 23

Under 21 CFR Part 812, what is required if a device study results in a serious adverse event?

Answer 23

10 working days

Question 24

Within how many days must an investigator submit a final report to the sponsor and the reviewing IRB after completion of a clinical investigation involving a medical device?

A. Within 7 calendar days
B. Within 15 calendar days
C. Within 30 calendar days
D. Within 90 calendar days

Answer 24

C