timelines

Question 1

investigator must submit documentation of consent exception to the IRB in ____ days

Answer 1

5 working days

Question 2

the IRB must keep emergency research documentation for ___

Answer 2

3 years after completion of investigation

Question 3

the IRB has to submit registration renewals to the FDA ___

Answer 3

every 3 years

Question 4

IRB records are kept for __

Answer 4

3 years after completion of investigation

Question 5

the FDA has ___ to respond to sponsor re: IND determination

Answer 5

30 days

Question 6

sponsor has ___ to submit new IND investigators to FDA

Answer 6

30 days

Question 7

sponsor must submit an IND safety report to the investigators and FDA no later than __

Answer 7

15 calendar days

Question 8

If the FDA requests for additional info to IND safety reports, the sponsor has ___ days to submit it

Answer 8

15 calendar days

Question 9

Sponsor must report any unexpected FATAL or LIFE THREATENING SAR reports to FDA ASAP but no later than ___

Answer 9

7 calendar days

Question 10

Adverse events that become reportable as an IND safety report, has to be reported by sponsor to FDA, no later than ___

Answer 10

15 calendar days

Question 11

Within _____ days of the anniversary date that an IND went into effect, a sponsor-investigator must submit a brief annual report of the progress of the trial.

Answer 11

annually within 60 days of the anniversary of the date that the IND was initially accepted by the FDA

Question 12

FDA has ___ to respond to a sponsor’s request to remove IND clinical hold

Answer 12

30 calendar days

Question 13

IND clinical hold will be moved to inactive status after __

Answer 13

1 year

Question 14

An IND’s inactive status will be moved to termination after __

Answer 14

5 years of being inactive

Question 15

Sponsor has ___ days to respond to the FDA’s notice of IND termination

Answer 15

30 days

Question 16

If the sponsor wants to request for a regulatory hearing with the FDA, they must respond within ___ of receiving the receipt

Answer 16

10 days

Question 17

Sponsor has ___ days to respond to the FDA’s notice of IND inactivation

Answer 17

30 days

Question 18

FDA has ___ to respond to the sponsor’s protocol amendments submitted for the request to resume an inactive IND

Answer 18

30 days

Question 19

sponsor must keep records and reports for __

Answer 19

2 years after the end of the investigation

Question 20

investigator must keep records and reports for ___

Answer 20

2 years after the end of the investigation

Question 21

investigator must keep the financial disclosure form updated for ___

Answer 21

up to 1 year following the completion of an investigation

Question 22

if a device is used without informed consent, the investigator must report this to sponsor within ___

Answer 22

5 working days

Question 23

Investigator must notify sponsor of an IRB approval withdrawal within ___

Answer 23

5 working days

Question 24

Sponsor must notify FDA and all investigators if they receive a withdrawal of IRB approval within ___

Answer 24

5 working days

Question 25

investigator has __ to report unanticipated adverse device effects to sponsor

Answer 25

10 working days

Question 26

sponsor has ___ to report any unanticipated adverse device effects to the FDA and all investigators

Answer 26

10 working days

Question 27

sponsor must notify investigators of an approval withdrawal from the FDA within __

Answer 27

5 working days

Question 28

The current investigators list must be updated by the sponsor and reported to FDA and investigators every ___

Answer 28

every 6 months and for 6 months after the end of the investigation

Question 29

sponsor has __ to inform FDA and investigators of a device disposition and recall

Answer 29

30 working days

Question 30

sponsor has to notify the FDA of the completion or termination of an investigation within ___

Answer 30

30 working days after the end

Question 31

sponsor must submit the final report to the FDA ___

Answer 31

6 months from the end of the investigation

Question 32

If the IRB determined a significant risk device, the sponsor has ___ to report it to the FDA

Answer 32

5 working days

Question 33

if sponsor determined an unexpected adverse event to be an unreasonable risk, the termination of investigation would occur __ days after determination by sponsor and no later than ___ after receiving notice

Answer 33

5 WORKING DAYS after determination by sponsor

no later than 15 DAYS after receiving notice

Question 34

Any changes to the investigational plan, the sponsor has to report it to the FDA within ___

Answer 34

5 working days

Question 35

FDA has ___ to inform sponsor of treatment IDE determinations

Answer 35

30 days

Question 36

Sponsor must submit a treatment IDE report to the FDA and IRBs every ____

Answer 36

every 6 months and 6 months after the end of the investigation

Question 37

At least _____ in advance of an End-of-Phase 2 meeting, the sponsor should submit background information of the sponsor’s plan for Phase 3.

Answer 37

1 month

Question 38

A clinical protocol change that that does not have a significant impact on the study design, analysis, and that does not affect the rights, safety, and welfare of the subjects can be made without prior FDA approval if the sponsor _____.

Answer 38

submits a notice of change to the IDE no later than 5 days after making the change