Important Timelines Flashcards
IND will be inactivated if all Investigators covered by it remain on clinical hold for ______ or more.
1 year
How long is IRB registration with HHS effective for?
3 years
Sponsor shall notify all IRBs & Investigators within ____ if there is withdrawal of FDA approval.
5 working days
Sponsor should submit to FDA a current list of names of Investigators participating every ____.
6 months
The FDA must make a decision on an NDA within ___ of receipt.
12 months
Sponsor & Investigator shall retain records for at least ____ after marketing is approved OR investigation becomes inactive.
2 years
For fatal or life-threatening unexpected ADRs or adverse events, regulatory agencies should be notified ____, but no later than ____ after first knowledge by Sponsor, followed by a complete-as-possible report within ____.
ASAP, 7 calendar days, 15 calendar days
Sponsor must report IND safety reports to FDA & Investigators within ____.
15 calendar days
FDA has how long to respond to Sponsor request to lift IND hold after receipt?
30 calendar days
A Sponsor shall provide a brief report within _____ of anniversary date IND went into effect.
60 days
Serious, unexpected, ADRs that are NOT fatal or life-threatening should be filed ___ but no later than ____ after first knowledge by Sponsor that case meets criteria.
ASAP, 15 calendar days
Grounds for termination if IND remains inactive for ____ or more.
5 years
The Investigator shall update FDF with any relevant changes that occur during the course of the study, plus _____ following its completion.
1 year
Sponsor request for regulatory hearing must be made within ___ of Sponsor receipt of FDA notification of nonacceptance of IND.
10 days
If Sponsor determines an unanticipated AE presents unreasonable risk, termination shall occur within _____ and not later than ____ after Sponsor received notice of AE.
5 working days, 15 working days
If FDA proposes to terminate IND, they must notify Sponsor within ____.
30 days
How often must an IRB renew HHS registration?
Every 3 years
If no subjects are enrolled within ___ or IND remains on hold for___ or more, IND can be put in inactive status.
2 years, 1 year
FDA will provide written determination within ____ after FDA receives IND/IDE.
30 days
Within _____ after termination or completion of trial, Investigator must submit a final report to Sponsor & IRB.
3 months
Deviations from protocol in emergency situations should be reported to the Sponsor within ___ after emergency.
5 working days
All IRB records must kept for at least ____ following completion of research.
3 years
Decision to disband a registered IRB must be reported to OHRP in writing within ___ after permanent stop of review of research.
30 days
The Sponsor must provide notice to FDA within ______ when making a change to an IDE.
5 working days
If immediate use of test article is required (as determined by PI), where IRB determination cannot be granted, a statement of exemption from PI plus independent clinician must be submitted to IRB within ___ after use.
5 working days
Investigator shall report to Sponsor within _____ if there is a withdrawal from IRB approval.
5 working days
IRB determinations for emergency situations must be retained by IRB for at least ___ after completion of clinical investigation.
3 years
In significant risk device research, Sponsor shall notify FDA within _____ after completion of investigation and shall submit a final report within _____.
30 working days, 6 months
IRB registration info must be updated within ____ after changes to contact person who provided IRB registration OR the IRB chairperson occurs.
90 days
The Division Director will provide Sponsor written explanation no more than _____ after imposing a clinical hold on an IND.
30 days
Sponsor will notify FDA, IRBs & Investigators within ____ after learning of a recall and device disposition.
30 working days
Unanticipated device AE should be reported by Investigator to Sponsor & IRB within ____ of knowledge of AE.
10 working days
An IND goes into effect ___ after the FDA acknowledges receipt, unless FDA notifies Sponsor of clinical hold.
30 days
If an Investigator uses a device without consent, it must be reported to Sponsor & IRB within ____.
5 working days
