Important Timelines

Question 1

How long is IRB registration with HHS effective for? 45CFR46.502

Answer 1

3 years

Question 2

IRB must renew registration every ___ years (45CFR46.505)

Answer 2

3

Question 3

IRB Registration info must be updated within ____ days after changes occur regarding the contact person who provided the IRB registration OR the IRB chairperson

Answer 3

90 days

Question 4

An institution or organizations decision to disband a registered IRB also must be reported to OHRP in writing within ___ days after permanent cessation of ORBs review of supported research (45cfr46.505)

Answer 4

30 days

Question 5

For Fatal or life threatening Unexpected ADRs or adverse events regulatory agencies should be notified ____ but no later than ____ calendar days after first knowledge by sponsor, follow by a completed as possible report within ____ additional calendar days

Answer 5

ASAP, 7, 8

Question 6

Serious,unexpected ADRs that are not fatal or life threatening must be filed ASAP but no later than ____ calendar days after first knowledge by sponsor that case meets criteria

Answer 6

15

Question 7

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

Answer 7

5

Question 8

IRB determinations for emergency situations are to be retained by IRB for at least ___ years after completion of clinical investigation

Answer 8

3

Question 9

Al IRB records need to be kept for ____ years follow completion of research

Answer 9

3

Question 10

FDA will provide written determination within ____ days after FDA receives IND or IDE

Answer 10

30 days

Question 11

Sponsor needs to report IND safety reports to FDA and investigators within ____ calendar days

Answer 11

15

Question 12

A sponsor shall within _____ days of anniversary date the IND went into effect provide a brief report

Answer 12

60

Question 13

No more than _____ days after imposing a clinical hold on an IND will the division director provide sponsor a written explanation for the hold

Answer 13

30 days

Question 14

FDA has ____ days to respond to a sponsor request to lift an IND hold

Answer 14

30 calendar days after receipt

Question 15

If all investigators covered by an IND Regina on clinical hold for ______ or more, IND will be inactivated

Answer 15

1 year

Question 16

Ground for termination : IND remains inactive for ____ years

Answer 16

5 or more

Question 17

If FDA proposes to terminate IND, they will notify sponsor within ____ days

Answer 17

30

Question 18

The sponsor request for regulatory hearing must be made within ___ days of sponsor receipt of FDA notification of nonacceptance of IND

Answer 18

10

Question 19

If no subject are enrolled within ___ years or or if IND remains on hold for___ year, the IND can be out in inactive status

Answer 19

2 years, 1 year

Question 20

A sponsor and investigator shall retain records for ____ years after marketing is approved OR investigation becomes inactive

Answer 20

2

Question 21

The clinical investigator shall update FDF with any relevant changes that occur during the course of the study and for _____ year following its completion

Answer 21

1

Question 22

The sponsor must provide notice to FDA within ______ working days when making a change to an IDE

Answer 22

5

Question 23

A sponsor who determines and unanticipated AE presents unreasonable risk, termination shall occur within _____ working days and not later than ___ working days after sponsor first received notice of effect

Answer 23

5; 15

Question 24

Unanticipated device AE should be reported by investigator to sponsor and IRB within ____ working days of knowledge of effect

Answer 24

10

Question 25

And investigator shall report to sponsor within _____ working days of there is a withdrawal from IRB approval

Answer 25

5

Question 26

Deviation from protocol that are emergencies situations should be reported within ___ working days after emergency

Answer 26

5

Question 27

If an investigator uses a device without consent, it needs to be reported to sponsor and IRB within ____ working days

Answer 27

5

Question 28

Within _____ months after termination or completion of trial, submit a final report to sponsor and IRB

Answer 28

3 months

Question 29

A sponsor shall notify all IRBs and investigators within ____ working days of there is withdrawal of FDA approval

Answer 29

5

Question 30

A sponsor should submit to FDA a current list of names of investigators participating every ___ months

Answer 30

6

Question 31

Sponsor will notify FDA, IRBS and Investigators within _____days after learning of a recall and device disposition.

Answer 31

30 working

Question 32

In sig risk device, sponsor shall notify FDA within _____ days after completions of or investigation and shall submit a final report within _____ months

Answer 32

30 working ; 6 months