Important Timelines Flashcards
How long is IRB registration with HHS effective for? 45CFR46.502
3 years
IRB must renew registration every ___ years (45CFR46.505)
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
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 ORBs review of supported research (45cfr46.505)
30 days
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
ASAP, 7, 8
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
15
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
5
IRB determinations for emergency situations are to be retained by IRB for at least ___ years after completion of clinical investigation
3
Al IRB records need to be kept for ____ years follow completion of research
3
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
A sponsor shall within _____ days of anniversary date the IND went into effect provide a brief report
60
No more than _____ days after imposing a clinical hold on an IND will the division director provide sponsor a written explanation for the hold
30 days
FDA has ____ days to respond to a sponsor request to lift an IND hold
30 calendar days after receipt
If all investigators covered by an IND Regina on clinical hold for ______ or more, IND will be inactivated
1 year
Ground for termination : IND remains inactive for ____ years
5 or more
If FDA proposes to terminate IND, they will notify sponsor within ____ days
30
The sponsor request for regulatory hearing must be made within ___ days of sponsor receipt of FDA notification of nonacceptance of IND
10
If no subject are enrolled within ___ years or or if IND remains on hold for___ year, the IND can be out in inactive status
2 years, 1 year
A sponsor and investigator shall retain records for ____ years after marketing is approved OR investigation becomes inactive
2
The clinical investigator shall update FDF with any relevant changes that occur during the course of the study and for _____ year following its completion
1
The sponsor must provide notice to FDA within ______ working days when making a change to an IDE
5
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
5; 15
Unanticipated device AE should be reported by investigator to sponsor and IRB within ____ working days of knowledge of effect
10
And investigator shall report to sponsor within _____ working days of there is a withdrawal from IRB approval
5
Deviation from protocol that are emergencies situations should be reported within ___ working days after emergency
5
If an investigator uses a device without consent, it needs to be reported to sponsor and IRB within ____ working days
5
Within _____ months after termination or completion of trial, submit a final report to sponsor and IRB
3 months
A sponsor shall notify all IRBs and investigators within ____ working days of there is withdrawal of FDA approval
5
A sponsor should submit to FDA a current list of names of investigators participating every ___ months
6
Sponsor will notify FDA, IRBS and Investigators within _____days after learning of a recall and device disposition.
30 working
In sig risk device, sponsor shall notify FDA within _____ days after completions of or investigation and shall submit a final report within _____ months
30 working ; 6 months
