Important Timelines

Question 1

IND will be inactivated if all Investigators covered by it remain on clinical hold for ______ or more.

Answer 1

1 year

Question 2

How long is IRB registration with HHS effective for?

Answer 2

3 years

Question 3

Sponsor shall notify all IRBs & Investigators within ____ if there is withdrawal of FDA approval.

Answer 3

5 working days

Question 4

Sponsor should submit to FDA a current list of names of Investigators participating every ____.

Answer 4

6 months

Question 5

The FDA must make a decision on an NDA within ___ of receipt.

Answer 5

12 months

Question 6

Sponsor & Investigator shall retain records for at least ____ after marketing is approved OR investigation becomes inactive.

Answer 6

2 years

Question 7

For fatal or life-threatening unexpected ADRs or adverse events, regulatory agencies should be notified ____, but no later than ____ after first knowledge by Sponsor, followed by a complete-as-possible report within ____.

Answer 7

ASAP, 7 calendar days, 15 calendar days

Question 8

Sponsor must report IND safety reports to FDA & Investigators within ____.

Answer 8

15 calendar days

Question 9

FDA has how long to respond to Sponsor request to lift IND hold after receipt?

Answer 9

30 calendar days

Question 10

A Sponsor shall provide a brief report within _____ of anniversary date IND went into effect.

Answer 10

60 days

Question 11

Serious, unexpected, ADRs that are NOT fatal or life-threatening should be filed ___ but no later than ____ after first knowledge by Sponsor that case meets criteria.

Answer 11

ASAP, 15 calendar days

Question 12

Grounds for termination if IND remains inactive for ____ or more.

Answer 12

5 years

Question 13

The Investigator shall update FDF with any relevant changes that occur during the course of the study, plus _____ following its completion.

Answer 13

1 year

Question 14

Sponsor request for regulatory hearing must be made within ___ of Sponsor receipt of FDA notification of nonacceptance of IND.

Answer 14

10 days

Question 15

If Sponsor determines an unanticipated AE presents unreasonable risk, termination shall occur within _____ and not later than ____ after Sponsor received notice of AE.

Answer 15

5 working days, 15 working days

Question 16

If FDA proposes to terminate IND, they must notify Sponsor within ____.

Answer 16

30 days

Question 17

How often must an IRB renew HHS registration?

Answer 17

Every 3 years

Question 18

If no subjects are enrolled within ___ or IND remains on hold for___ or more, IND can be put in inactive status.

Answer 18

2 years, 1 year

Question 19

FDA will provide written determination within ____ after FDA receives IND/IDE.

Answer 19

30 days

Question 20

Within _____ after termination or completion of trial, Investigator must submit a final report to Sponsor & IRB.

Answer 20

3 months

Question 21

Deviations from protocol in emergency situations should be reported to the Sponsor within ___ after emergency.

Answer 21

5 working days

Question 22

All IRB records must kept for at least ____ following completion of research.

Answer 22

3 years

Question 23

Decision to disband a registered IRB must be reported to OHRP in writing within ___ after permanent stop of review of research.

Answer 23

30 days

Question 24

The Sponsor must provide notice to FDA within ______ when making a change to an IDE.

Answer 24

5 working days

Question 25

If immediate use of test article is required (as determined by PI), where IRB determination cannot be granted, a statement of exemption from PI plus independent clinician must be submitted to IRB within ___ after use.

Answer 25

5 working days

Question 26

Investigator shall report to Sponsor within _____ if there is a withdrawal from IRB approval.

Answer 26

5 working days

Question 27

IRB determinations for emergency situations must be retained by IRB for at least ___ after completion of clinical investigation.

Answer 27

3 years

Question 28

In significant risk device research, Sponsor shall notify FDA within _____ after completion of investigation and shall submit a final report within _____.

Answer 28

30 working days, 6 months

Question 29

IRB registration info must be updated within ____ after changes to contact person who provided IRB registration OR the IRB chairperson occurs.

Answer 29

90 days

Question 30

The Division Director will provide Sponsor written explanation no more than _____ after imposing a clinical hold on an IND.

Answer 30

30 days

Question 31

Sponsor will notify FDA, IRBs & Investigators within ____ after learning of a recall and device disposition.

Answer 31

30 working days

Question 32

Unanticipated device AE should be reported by Investigator to Sponsor & IRB within ____ of knowledge of AE.

Answer 32

10 working days

Question 33

An IND goes into effect ___ after the FDA acknowledges receipt, unless FDA notifies Sponsor of clinical hold.

Answer 33

30 days

Question 34

If an Investigator uses a device without consent, it must be reported to Sponsor & IRB within ____.

Answer 34

5 working days