Timelines Flashcards
(32 cards)
Fatal or life-threatening,
unexpected ADRs should be reported as soon as possible but no later than
7 calendar days
after first knowledge by the sponsor that a case qualifies, followed by as complete a report as possible within 8 additional calendar days.
Serious, unexpected ADRs that are not fatal or life threatening must be filed asap but no later than _____ calendar days after first awareness by SPONSOR
15 days
emergency use where informed consent cannot be granted, PI must submit to IRB within ____ working days
5 days
From when IND came into effect, sponsor shall provide a brief report within
60 days
Division Director with responsibility for review of the IND. As
soon as possible, and no more than ___ days after imposition of the clinical hold, the Division Director will provide the sponsor a
written explanation of the basis for the hold.
30 days
IND will be inactivated if clinical hold lasts for ___
1 year
Ground for termination of IND if IND remains inactive for _____ years
5 or more years
If there are no subjects enrolled within _____ years or if IND remains on hold for ____ year, the IND can be inactive status
2 years, 1 year
How long is IRB registration with HHS effective for? 45CFR46.502
3 years
IRB must renew registration every ___ years (45CFR46.505)
3 years
IRB Registration info must be updated within ____ days after changes occur regarding the contact person who provided the IRB registration OR the IRB chairperson
90 days
An institution or organizations decision to disband a registered IRB also must be reported to OHRP in writing within ___ days after permanent cessation of IRBs review of supported research (45cfr46.505)
30 days
IRB determinations for emergency situations are to be retained by IRB for at least ___ years after completion of clinical investigation
3 years
All IRB records need to be kept for ____ years follow completion of research
3 years
FDA will provide written determination within ____ days after FDA receives IND or IDE
30 days
Sponsor needs to report IND SAFETY reports to FDA and investigators within ____ calendar days
15 days
FDA has ____ days to respond to a sponsor request to lift an IND hold
30 calendar days after receipt
If FDA proposes to terminate IND, they will notify sponsor within ____ days
30 days
The sponsor request for regulatory hearing must be made within ___ days of sponsor receipt of FDA notification of nonacceptance of IND
10 days
A sponsor and investigator shall retain records for ____ years after marketing is approved OR investigation becomes inactive
2 years
The clinical investigator shall update FDF (financial disclosure form) with any relevant changes that occur during the course of the study and for _____ year(s) following its completion
1 year
The sponsor must provide notice to FDA within ______ working days when making a change to an IDE
5 days
A sponsor who determines an unanticipated AE presents UNREASONABLE risk then termination shall occur within _____ working days and not later than ___ working days after sponsor first received notice of effect
5 days; 15 days
Unanticipated device AE should be reported by investigator to sponsor and IRB within ____ working days of knowledge of effect
10 days
