Reporting timelines

Question 1

A sponsor must notify all reviewing IRBs and participating investigators of an FDA approval withdrawl within XXX days

Answer 1

5 working days

Question 2

Significant Risk Device Determination

Answer 2

5 working days

Question 3

No consent obtained after using device

Answer 3

5 working days

Question 4

Investigator submits FINAL REPORT to IRB & Sponsor within?

Answer 4

3 months/90days

Question 5

Unanticipated Adverse Device Effect, Sponsor to FDA

Answer 5

10 working days

Question 6

Unanticipated Adverse Device Effect, Investigator to Sponsor & IRB

Answer 6

ASAP, 10 working days

Question 7

Recall and Device Disposition report to FDA within how many days?

Answer 7

30 working days

Question 8

Deviation from Investigational Plan

Answer 8

5 working days

Question 9

The time it takes to submit an IND depends on the severity of the event. When would the sponsor have to submit for a follow up or serious unexpected but non-fatal? IND Safety Report, Sponsor to FDA & Site

Answer 9

15 calendar days

Question 10

Unexpected Fatal or life threatening suspected adverse reaction, Sponsor to FDA

Answer 10

7 calendar days

Question 11

A sponsor shall within X days of the XXX date that the IND went into effect, submit a brief report of the progress of the investigation

Answer 11

60 days of anniversary of IND

Question 12

IND application goes in effect in how many days

Answer 12

30 days after FDA receives IND.

Question 13

sponsor shall maintain adequate records for X years

Answer 13

2

Question 14

The sponsors request for a regulatory hearing must be made within ___ of the sponsors receipt of FDA’s notification of nonacceptance.

Answer 14

10 days

Question 15

Sponsor to report non threatening unexpected ADRs (adverse drug reactions)?

Answer 15

15 calendar days after first knowledge.

Question 16

For emergency use of a drug, where immediate use of the product was required and the patient was not able to be consented, how long does the sponsor have to notify the FDA of the use of the product?

Answer 16

5 working days

Question 17

For an IND, how soon should the sponsor report serious unexpected life-threatening safety events to FDA?

Answer 17

7 calendar days

Question 18

INDs that are “Inactive” for ___+ years may be terminated

Answer 18

5 years

Question 19

IRB must maintain records for X years

Answer 19

3 years

Question 20

Sponsor submits FINAL REPORT to IRB within?

Answer 20

6 months

Question 21

Sponsor must notify FDA of completion or termination within XX days

Answer 21

30 working days

Question 22

The sponsor of a clinical trial must submit a final report to ClinicalTrials.gov no later than

Answer 22

1 Year after the primary completion date:

Question 23

Records custody. An investigator or sponsor may withdraw from the responsibility to maintain records for the period
required in paragraph (d) of this section and transfer custody of the records to any other person who will accept responsibility for
them under this part, including the requirements of §812.145. Notice of a transfer shall be given to FDA not later than XXX working
days after transfer occurs

Answer 23

10 working days