TIMELINES FOR REPORTING

Question 1

Emergency procedures: if Written submission of IND is not possible to be submitted to FDA, FDA may authorize via phone. But physician or sponsor must still submit an expanded access submission

Answer 1

Within 15 working days of FDA’s authorization of use

Question 2

21CFR50.23 4b: If immediate use of test article is required to preserve life of subject and there is insufficient time to obtain consent, the determinations of the clinical investigator shall be made (also applies to investigational device)

Answer 2

within 5 working days after use of test article, be reviewed by physician not participating in clinical investigation and submitted to IRB within 5 working days after use of test article

Question 3

21CFR56.104 emergency use of test article is exempt from IRB review if it is reported to IRB within

Answer 3

5 working days

Question 4

IF IRB contact or chairperson information changes, the IRB must revise its registration information by submitting new information with

Answer 4

90 days of change

Question 5

IRB must report a change in decision of IRB to review new types of FDA-regulated products (such as studies pertaining to food additives whereas previously only reviewed studies pertaining to drug products)

Answer 5

within 30 days of the change

Question 6

IRB must report decision to discontinue reviewing clinical investigations regulated by FDA

Answer 6

within 30 days of the change

Question 7

IRB’s decision to disband must be reported

Answer 7

within 30 days of permanent cessation of IRBs review of research

Question 8

IRB changes that are not related to change in review of types of studies, discontinuation of review of clinical investigations, or permanent cessation may be reported

Answer 8

when IRB renews its registration

Question 8

how often must IRB renew registration

Question 9

FDA shall provide written determination of IND disapproval

Answer 9

30 days after FDA receives the IND or earlier. If not placed on hold, study may proceed

Question 10

Once IND is active, sponsor must notify FDA of new investigator

Answer 10

within 30 days of investigator being added

Question 11

Protocol amendments to add a new investigator or provide information about investigators may be grouped and submitted

Answer 11

at 30 day intervals

Question 12

IND Safety reports, sponsor and shall notify participating investigators and FDA of an IND safety report of potential serious risk, from clinical trial, or any other source

Answer 12

ASAP, but no later than 15days after sponsor determines that information qualifies for reporting

Question 13

if FDA requests additional data or information that is deemed necessary, sponsor must submit to FDA

Answer 13

ASAP, but no later than 15 calendar days after receiving the request

Question 14

sponsor must notify FDA of any unexpected fatal or life threatening suspected adverse reactions

Answer 14

ASAP but no later than 7 calendar days after sponsor’s initial receipt of information

Question 15

if sponsor’s investigation show that an adverse event not initially determined to be reportable, is in fact reportable, the sponsor must report adverse reaction in an IND safety report

Answer 15

ASAP but in no case later than 15 calendar days after the determination is made

Question 16

a sponsor within ____ _____ of the anniversary date that an IND went into effect, submit a brief report of progress

Answer 16

60 days

Question 17

an IND goes into effect __________ after FDA receives IND unless IND are subject to clinical hold

Answer 17

30 days

Question 18

The division director will provide the sponsor with a written explanation of the basis of the hold no more than

Answer 18

30 days after imposition of clinical hold

Question 19

If sponsor responds to FDA clinical hold, but FDA doesn’t accept explanation or correction. The sponsor may request a regulatory hearing

Answer 19

within 10 days of sponsor’s receipt of FDA’s notification of nonacceptance

Question 20

312.45 IF FDA places IND on inactive status, the sponsor will have _______ ____ to respond as to why IND should continue to remain active

Answer 20

30 days

Question 21

312.56 A sponsor who determines that its investigation drug presents an unreasonable and significant risk to subjects must discontinue investigation

Answer 21

ASAP, but no later than 5 working days after determination that the investigation must be discontinued

Question 22

Investigations subject to IND’s. A sponsor that, on July 16, 1980, has an effective investigational new drug application (IND) for an investigation of a device shall continue to comply with the requirements of part 312 until ___ ___after that date

Answer 22

90 days

Question 23

sponsor or applicant must retain records of clinical study not conducted under an IND for

Answer 23

2 years after an agency decision that application for marketing approval, for 2 years after submission of the IND

Question 24

Drugs for investigational use in lab research animals or in vitro tests: records of shipments are to be maintained

Answer 24

2 years after the shipment

Question 25

a sponsor or applicant must retain records of clinical investigation for an IDE

Answer 25

for 2 years after termination or completion of IDE

Question 26

financial disclosure and changes over the course of investigation are to be reported for ______ _____ following completion of study

Answer 26

1 year

Question 27

An investigator or sponsor shall maintain the records required by this subpart during the investigation and for a period of ___ ___ after the latter of the following two dates: The date on which the investigation is terminated or completed, or the date that the records are no longer required for purposes of supporting a premarket approval applica

Answer 27

2 years