TIMELINES FOR REPORTING Flashcards
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
Within 15 working days of FDA’s authorization of use
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)
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
21CFR56.104 emergency use of test article is exempt from IRB review if it is reported to IRB within
5 working days
IF IRB contact or chairperson information changes, the IRB must revise its registration information by submitting new information with
90 days of change
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)
within 30 days of the change
IRB must report decision to discontinue reviewing clinical investigations regulated by FDA
within 30 days of the change
IRB’s decision to disband must be reported
within 30 days of permanent cessation of IRBs review of research
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
when IRB renews its registration
how often must IRB renew registration
FDA shall provide written determination of IND disapproval
30 days after FDA receives the IND or earlier. If not placed on hold, study may proceed
Once IND is active, sponsor must notify FDA of new investigator
within 30 days of investigator being added
Protocol amendments to add a new investigator or provide information about investigators may be grouped and submitted
at 30 day intervals
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
ASAP, but no later than 15days after sponsor determines that information qualifies for reporting
if FDA requests additional data or information that is deemed necessary, sponsor must submit to FDA
ASAP, but no later than 15 calendar days after receiving the request
sponsor must notify FDA of any unexpected fatal or life threatening suspected adverse reactions
ASAP but no later than 7 calendar days after sponsor’s initial receipt of information
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
ASAP but in no case later than 15 calendar days after the determination is made
a sponsor within ____ _____ of the anniversary date that an IND went into effect, submit a brief report of progress
60 days
an IND goes into effect __________ after FDA receives IND unless IND are subject to clinical hold
30 days
The division director will provide the sponsor with a written explanation of the basis of the hold no more than
30 days after imposition of clinical hold
If sponsor responds to FDA clinical hold, but FDA doesn’t accept explanation or correction. The sponsor may request a regulatory hearing
within 10 days of sponsor’s receipt of FDA’s notification of nonacceptance
312.45 IF FDA places IND on inactive status, the sponsor will have _______ ____ to respond as to why IND should continue to remain active
30 days
312.56 A sponsor who determines that its investigation drug presents an unreasonable and significant risk to subjects must discontinue investigation
ASAP, but no later than 5 working days after determination that the investigation must be discontinued
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
90 days
sponsor or applicant must retain records of clinical study not conducted under an IND for
2 years after an agency decision that application for marketing approval, for 2 years after submission of the IND
