Module 1 Time Points Flashcards
How long is IRB registration with HHS effective?
45 CFR 46.502
3 Years
IRB must renew registration every ___ years
45 CFR 46.505
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 organization’s decision to disband a registered IRB also must be reported to OHRP in writing within ___ days after permanent cessation or ORB’s review of supported research
45 CFR 46.505
30 days
For fatal or life-threatening unexpected ADR’s or adverse events- regulatory agencies should be notified ___ but no later than ___ days after first knowledge by sponsor, followed by a completed report within ___ additional days
ASAP
7 days
8 days
Serious, unexpected ADR’s that are not fatal or life threatening must be filed ASAP but no later than ___ calendar days after first knowledge by sponsor
15 days
If immediate use of test article is required (as determined by PI) where independent determination cannot be granted, a statement with exemption from the PI and independent clinician must be submitted to IRB within ___ working days after use of the test article.
5 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 following 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
A sponsor shall provide a brief report within ___ days of anniversary date the IND went into effect
60 days
No more than ___ days after imposing a clinical hold on an INBD will the division director provide a sponsor a written explanation for the hold.
30 days
FDA has ___ days to respond to a sponsor’s request to life an IND hold
30 calendar days after receipt
If all investigators covered by an IND remain on clinical hold for ___ year or more the IND will be inactivated.
1 year
Ground for termination if IND remains inactive for ___
5+ years
If FDA proposes to terminate an IND, they will notify the 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
If no subjects are enrolled within ___ years or if IND remains on hold for ___ year, the IND can be put into inactive status
2 years
1 year
A sponsor and investigator shall retain records for ___ years after marketing is approved OR investigation becomes inactive.
2 years
The clinical investigator shall update FDA with any relevant changes that occur during the course of the study and for ___ year following it’s completion.
1 year
The sponsor must provide notice to FDA within ___ working days when making a change to an IDE
5 days
When a sponsor determines that an unanticipated AE presents unreasonable risk, termination shall occur within ___ working days and no later than ___ working days after sponsor first received notice of effect.
5 days
15 days
Unanticipated device AE should be reported by investigator to the sponsor and IRB within ___ working days of knowledge
10 days
